A syringe is essentially a device used in medicine to inject fluid into or withdraw fluid from the body. Medical syringes consist of a needle attached to a hollow cylinder that is fitted with a sliding plunger. The downward movement of the plunger injects fluid; upward movement withdraws fluid. A prefilled syringe is a single-dose packet of vaccine to which a needle has been fixed by the manufacturer. A prefilled syringe is not positioned as a high technology product such as needle free injectors which involves pioneering drug delivery technologies. Neither is it a simple technology (for example tabulating). Instead it is positioned in the middle, being on the border line of simple to advance.
The growth rate is to be expected to remain at a high level of more than 10% annually. This is due to a number of factors such as greater medication safety and increased convenience from using a prefillable device.
Prefilled syringes accommodate volumes that typically range from 0.25 to 5.0 ml. They are therefore best suited to products administered by subcutaneous or intramuscular injection. The categories account for the bulk of prefilled syringes: vaccines, blood stimulants, therapeutic proteins, erythroproteins, interferons and rheumatoid arthritis
FDA on Prefilled Syringes and Combination Products (Lana Shiu,MD)Sun Kim
Audio at http://QbDWorks.com
(Courtesy of Dr. Lana Shiu of FDA)
I met Dr. Lana Shiu after her presentation at the PDA conference. She gladly agreed to share her talk with our QbDWorks community.
What Dr. Shiu covers:
Why FDA is focusing on Combination Products Now
Why this applies to all of us
Case study of failed combination product (prefilled syringe)
Background of Combination Products governed by FDA
Product Development Considerations
Human Factors Considerations
FDA Application Submission Guidelines
Lessons Learned
Key Steps to Successful Application
At the end of this article are links to the FDA guidelines:
Guidance Documents (finalized 2013)
Drug or Biologic using Injectors/Prefilled Syringes Assembled into Injectors
Prefilled Syringes - A Container of Choice for PharmaAjinomoto Althea
Special feature in the May 2012 issue of Drug Development and Delivery on Althea's Crystalomics technology, and how crystallized proteins create patient-friendly dosage and delivery.
Presentation given at SMI's Biosimilar and Biobetter Conference 2015 in London. The presentation discusses challenges and opportunities for developers of biosimilar products and how medical device components can provide a competitive advantage.
This document summarizes an upcoming conference on pre-filled syringes in Europe. The two-day conference will feature presentations and discussions on pre-filled syringe formulations, filling and finishing processes, primary and secondary packaging developments, regulatory compliance, and patient safety approaches. It will also include two post-conference workshops on self-injection devices and safety issues within pre-filled syringes. Key industry leaders and experts will speak on topics such as biologics formulations, extractables and leachables, facility design strategies, and regulatory trends. The conference aims to explore challenges and solutions for pre-filled syringe development and commercialization.
This document provides information about an upcoming conference on 4th Pre-Filled Syringes that will address challenges in developing efficacious pre-filled syringe products. The conference will take place from October 17-19, 2011 in London and will feature key speakers from companies such as AstraZeneca, Novartis, Bayer, and the UK Medicines and Healthcare products Regulatory Agency (MHRA). It will include topics such as manufacturing, formulation, quality, safety, and novel pre-filled syringe technologies. Attendees can gain insights on issues like ensuring drug identity, potency and sterility in pre-filled syringes.
The document advertises the 8th annual Pre-Filled Syringes Americas conference and exhibition taking place from March 31st to April 2nd, 2014 in Iselin, New Jersey. The conference will bring together over 85 key decision makers from leading biotechnology and pharmaceutical companies to discuss developments in pre-filled syringes and injection devices over the course of two days of presentations, panel discussions, and workshops. Attendees will have the opportunity to network with industry leaders, evaluate solutions from exhibitors, and return to their businesses with the information and contacts needed to make decisions for their products.
The document discusses the process for qualifying visual inspectors for pharmaceutical inspection including selecting inspectors based on vision and observation skills, extensive training using mock defect containers, and qualification testing to accurately identify defect types with acceptable error rates. It also reviews inspection parameters, defect categorization, sampling plans, and analytical techniques for investigating particulate matter found during inspection.
FDA on Prefilled Syringes and Combination Products (Lana Shiu,MD)Sun Kim
Audio at http://QbDWorks.com
(Courtesy of Dr. Lana Shiu of FDA)
I met Dr. Lana Shiu after her presentation at the PDA conference. She gladly agreed to share her talk with our QbDWorks community.
What Dr. Shiu covers:
Why FDA is focusing on Combination Products Now
Why this applies to all of us
Case study of failed combination product (prefilled syringe)
Background of Combination Products governed by FDA
Product Development Considerations
Human Factors Considerations
FDA Application Submission Guidelines
Lessons Learned
Key Steps to Successful Application
At the end of this article are links to the FDA guidelines:
Guidance Documents (finalized 2013)
Drug or Biologic using Injectors/Prefilled Syringes Assembled into Injectors
Prefilled Syringes - A Container of Choice for PharmaAjinomoto Althea
Special feature in the May 2012 issue of Drug Development and Delivery on Althea's Crystalomics technology, and how crystallized proteins create patient-friendly dosage and delivery.
Presentation given at SMI's Biosimilar and Biobetter Conference 2015 in London. The presentation discusses challenges and opportunities for developers of biosimilar products and how medical device components can provide a competitive advantage.
This document summarizes an upcoming conference on pre-filled syringes in Europe. The two-day conference will feature presentations and discussions on pre-filled syringe formulations, filling and finishing processes, primary and secondary packaging developments, regulatory compliance, and patient safety approaches. It will also include two post-conference workshops on self-injection devices and safety issues within pre-filled syringes. Key industry leaders and experts will speak on topics such as biologics formulations, extractables and leachables, facility design strategies, and regulatory trends. The conference aims to explore challenges and solutions for pre-filled syringe development and commercialization.
This document provides information about an upcoming conference on 4th Pre-Filled Syringes that will address challenges in developing efficacious pre-filled syringe products. The conference will take place from October 17-19, 2011 in London and will feature key speakers from companies such as AstraZeneca, Novartis, Bayer, and the UK Medicines and Healthcare products Regulatory Agency (MHRA). It will include topics such as manufacturing, formulation, quality, safety, and novel pre-filled syringe technologies. Attendees can gain insights on issues like ensuring drug identity, potency and sterility in pre-filled syringes.
The document advertises the 8th annual Pre-Filled Syringes Americas conference and exhibition taking place from March 31st to April 2nd, 2014 in Iselin, New Jersey. The conference will bring together over 85 key decision makers from leading biotechnology and pharmaceutical companies to discuss developments in pre-filled syringes and injection devices over the course of two days of presentations, panel discussions, and workshops. Attendees will have the opportunity to network with industry leaders, evaluate solutions from exhibitors, and return to their businesses with the information and contacts needed to make decisions for their products.
The document discusses the process for qualifying visual inspectors for pharmaceutical inspection including selecting inspectors based on vision and observation skills, extensive training using mock defect containers, and qualification testing to accurately identify defect types with acceptable error rates. It also reviews inspection parameters, defect categorization, sampling plans, and analytical techniques for investigating particulate matter found during inspection.
A phase 1 clinical trial includes the initial introduction of an investigational new drug product, including biological drug products, into humans. Such studies are conducted to establish the basic safety of the drug, and are designed to determine the metabolism and pharmacologic actions of the drug in humans. The total number of subjects in a phase 1 clinical trial is limited generally to no more than 80 subjects.
This presentation covers the CGMP’s for Investigation New Drugs for Phase I. The presentation has been compiled from publicly available material on the world wide web by “ Drug Regulations” a not for profit organization.
This document provides an agenda for the "2nd Prefilled Syringes Americas" conference taking place from April 5-7, 2011 in the USA. The conference will discuss trends in pre-filled syringes including new materials, components, and processes. Key topics include plastic syringe systems, drug delivery devices, technological developments, and advanced formulations for biologics. Speakers will represent companies like Bristol-Myers Squibb, Gerresheimer, West Pharmaceutical, and Arecor. The event aims to explore industry requirements and the latest innovations in pre-filled syringe product development.
Visual Inspection of Parentetal Drug Products in Pharmaceutical Quality testingKarishmaRK
Visual Inspection in Parenteral Drug Products
The document discusses visual inspection of parenteral drug products. It notes that visual inspection is needed to detect defects like particulate matter that could impact patient safety. Inspection is required by compendial and regulatory standards to ensure products are essentially free of visible particles. The summary describes the types of defects classified as critical, major, or minor and the acceptable quality limits for each. It also provides an overview of manual, semi-automated, and automated inspection methods and defines what constitutes a "visible particle" during the inspection process.
The document discusses guidelines for supplemental new drug applications (sNDAs) submitted to the FDA for post-approval changes. It categorizes changes as major, moderate or minor based on their potential impact. Major changes like new manufacturing sites or processes require prior approval. Moderate changes require submission 30 days before distribution or when received by FDA. Minor changes are described in annual reports. The types and levels of data required to support each change category are also outlined.
Bilcare provides clinical research and development, analytical, and formulation services for pharmaceutical products. They offer technical support and GMP-qualified scientists during product development and manufacturing. Their services include pre-formulation studies, clinical trial supplies manufacturing, analytical testing from method development through stability studies, and management of controlled substances. Bilcare ensures products meet international regulatory standards through quality review of all documentation.
This document is the contract services directory from Contract Pharma magazine. It lists over 200 categories of contract services for the pharmaceutical industry, ranging from analytical testing and clinical research to manufacturing, packaging, and regulatory support. The directory acts as a buyers' guide for those seeking external partners and providers across the drug development and production process.
Sterile filtration of complex injectables by Partha BanerjeeMilliporeSigma
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies.
As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable.
Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
Ranveer Sharma from the Department of Biotech at Bcet Gurdaspur presented on Panacea Biotec. Panacea Biotec is an Indian healthcare company focused on pharmaceuticals, biopharmaceuticals, vaccines and natural products. It has a global footprint in over 30 countries. Key highlights included its #4 ranking in vaccines in India, state-of-the-art manufacturing facilities approved by US FDA and WHO, and strategic collaborations with companies like Serum Institute of India and Apotex. Recent updates discussed a collaboration with Serum Institute on a hexavalent vaccine and a settlement agreement with Celgene regarding patents on Panacea's generic version of Abraxane.
Sovrin Plastics provides precision plastic injection moulding and contract manufacturing services for the medical, electronics, and engineering industries. They have over 45 years of experience as mould makers and precision injection moulders with 140 personnel, 52 moulding machines, and a 7,500 square meter facility. They specialize in manufacturing for the healthcare sector, with capabilities including drug delivery systems, diagnostics, surgical instruments, and implantable medical devices.
Vskills certification for Biopharmaceutical Professional assesses the candidate as per the company’s need for developing and managing biopharmaceuticals. The certification tests the candidates on various areas in types, sources of biopharmaceuticals which also includes methods of production and legal issues.
http://www.vskills.in/certification/Health-Nutrition-and-Well-being/Certified-Biopharmaceutical-Professional
This document discusses lubrication challenges with prefilled syringes and introduces TriboFilm Research's solutions. Silicone oil is commonly used to lubricate prefilled syringes but can migrate, causing inconsistent plunger forces and introducing particles into drugs. TriboFilm has developed an atmospheric plasma technology that can immobilize lubricants like silicone oil or its PFPE lubricant onto syringe surfaces, reducing lubricant migration issues. This plasma process crosslinks the lubricant during syringe manufacturing without contaminants.
This document discusses lubrication challenges with prefilled syringes and introduces TriboFilm Research's solutions. Silicone oil is commonly used to lubricate prefilled syringes but can migrate, causing inconsistent plunger forces and introducing particles into drugs. TriboFilm has developed an atmospheric plasma technology that can immobilize lubricants like silicone oil or its PFPE lubricant onto syringe surfaces, reducing lubricant migration issues. This plasma process crosslinks the lubricant during syringe manufacturing without contaminants.
This document is a curriculum vitae for Ramesh Chaudhari that summarizes his professional experience and qualifications. He has over 4 years of experience in formulation research and development. He currently works as a senior research associate and has previously worked as an officer of formulation and development. His areas of expertise include developing various dosage forms for regulated markets in line with cGMP guidelines. He holds an M.Pharm in pharmaceutics and has experience developing formulations for tablets, capsules, injections and semisolids.
This white paper aims to provide a comprehensive
overview of the CMC guidance by the U.S. Food and Drug
Administration and present a streamlined approach for
development and manufacture of nasal spray products
The Bioprocessing Summit
August 18-22, 2014 | Boston, MA
http://www.bioprocessingsummit.com
The Bioprocessing Summit brings together international leaders to discuss today's bioprocess issues from cell line
selection to bioproduction. The Summit provides practical details in a relaxed, congenial atmosphere that promotes information exchange and networking.
The Bioprocessing Summit continues to grow, and now comprises 12 distinct meetings in one event, including cell
culture, purification, bioproduction, quality, formulation, and novel biotherapeutic formats. The Summit also features small-group breakout discussions, networking in the busy exhibit hall, an extensive poster display, and an array of in-depth short courses and training seminars. For the full listing of speakers at this year's Summit, please click here.
This leading bioprocess meeting is hosted in Boston each summer along the lively and cosmopolitan harbor
waterfront. Hundreds of bioprocess professionals come together each year at the Summit to share practical
solutions for today’s laboratory challenges with researchers from around the world. Please visit the website www.bioprocessingsummit.com for more information and to register.
This document provides information about Poseidon Environmental Technology Co., Ltd., including its contact information, location, website, phone numbers, core capabilities, and services. The company focuses on research and development of membrane technology for water treatment and provides one-stop ultrafiltration membrane solutions and customized filter cartridge services to water purifier manufacturers. It aims to be a world-leading supplier of water filtration materials and strives for excellence in talent development and product quality.
This document discusses integration of prior knowledge in good manufacturing practices (GMP). It covers the animal and human trial process for new drug approval and generic drug approval. It also discusses ensuring quality of drugs through proper management of ingredients, manufacturing facilities, and processes. The document presents a case study on complaints regarding a drug product where the root cause was not properly investigated, resulting in a recall. It stresses the importance of thoroughly investigating quality issues and failures to ensure patient safety.
1. The document discusses dissolution method development for generic drug products, noting it is a critical tool for formulation development, getting waivers from bioequivalence studies, and ensuring quality after manufacturing changes.
2. It outlines the key steps in developing a dissolution method, including testing variants with different release characteristics, selecting a method with adequate discriminating power, determining bioavailability, and establishing dissolution specifications to ensure similar product performance.
3. Common deficiencies seen in applications are failing to demonstrate the method is discriminating, missing critical data on material attributes and process parameters, lack of data supporting acceptance criteria, and not submitting individual dissolution data.
Drug Delivery Systems Americas (2011) PpPiyush Patel
The two-day Drug Delivery Systems Americas conference in Boston will focus on the latest scientific research, manufacturing, and commercial opportunities in drug delivery systems. Key topics will include drug formulations for small molecules, proteins, peptides, and biologics; delivery technologies such as controlled release, nanotechnology, and biologics targeting; commercialization aspects including partnering, outsourcing, and regulations; and case studies. Over 20 industry leaders from companies including Novartis, Pfizer, Genzyme, and Abbott will present on challenges and innovations in developing advanced drug delivery technologies. Attendees will gain insights on enhancing bioavailability, managing product lifecycles, and identifying strategic partnerships in the growing field of drug delivery.
This document provides information about an upcoming conference on pre-filled syringes. It outlines the conference details including dates, location, key speakers from companies like Merck Serono and AstraZeneca. It also lists media partners, sponsors, and exhibitors. The document discusses the growing market for pre-filled syringes and challenges in the industry. It promotes the conference as a chance to learn about new developments, network, and address issues like drug compatibility and manufacturing processes. A pre-conference workshop on legal issues is also advertised.
2nd Pharmaceutical Anti Counterfeiting Americas (2011) PpPiyush Patel
This document provides information about the "2nd Pharmaceutical Anti-counterfeiting Americas" conference taking place on November 14-15, 2011 in Boston, USA. The conference will discuss combating counterfeit medicines and feature speakers from pharmaceutical companies and regulatory agencies. Attendees will learn about US policy updates, technologies for tracking pharmaceuticals, and best practices for supply chain integrity. Posters can be submitted by academic institutions, pharmaceutical companies, and service providers to share research results. The conference is aimed at professionals working in pharmaceutical supply chain security, anti-counterfeiting, brand protection, and related fields.
A phase 1 clinical trial includes the initial introduction of an investigational new drug product, including biological drug products, into humans. Such studies are conducted to establish the basic safety of the drug, and are designed to determine the metabolism and pharmacologic actions of the drug in humans. The total number of subjects in a phase 1 clinical trial is limited generally to no more than 80 subjects.
This presentation covers the CGMP’s for Investigation New Drugs for Phase I. The presentation has been compiled from publicly available material on the world wide web by “ Drug Regulations” a not for profit organization.
This document provides an agenda for the "2nd Prefilled Syringes Americas" conference taking place from April 5-7, 2011 in the USA. The conference will discuss trends in pre-filled syringes including new materials, components, and processes. Key topics include plastic syringe systems, drug delivery devices, technological developments, and advanced formulations for biologics. Speakers will represent companies like Bristol-Myers Squibb, Gerresheimer, West Pharmaceutical, and Arecor. The event aims to explore industry requirements and the latest innovations in pre-filled syringe product development.
Visual Inspection of Parentetal Drug Products in Pharmaceutical Quality testingKarishmaRK
Visual Inspection in Parenteral Drug Products
The document discusses visual inspection of parenteral drug products. It notes that visual inspection is needed to detect defects like particulate matter that could impact patient safety. Inspection is required by compendial and regulatory standards to ensure products are essentially free of visible particles. The summary describes the types of defects classified as critical, major, or minor and the acceptable quality limits for each. It also provides an overview of manual, semi-automated, and automated inspection methods and defines what constitutes a "visible particle" during the inspection process.
The document discusses guidelines for supplemental new drug applications (sNDAs) submitted to the FDA for post-approval changes. It categorizes changes as major, moderate or minor based on their potential impact. Major changes like new manufacturing sites or processes require prior approval. Moderate changes require submission 30 days before distribution or when received by FDA. Minor changes are described in annual reports. The types and levels of data required to support each change category are also outlined.
Bilcare provides clinical research and development, analytical, and formulation services for pharmaceutical products. They offer technical support and GMP-qualified scientists during product development and manufacturing. Their services include pre-formulation studies, clinical trial supplies manufacturing, analytical testing from method development through stability studies, and management of controlled substances. Bilcare ensures products meet international regulatory standards through quality review of all documentation.
This document is the contract services directory from Contract Pharma magazine. It lists over 200 categories of contract services for the pharmaceutical industry, ranging from analytical testing and clinical research to manufacturing, packaging, and regulatory support. The directory acts as a buyers' guide for those seeking external partners and providers across the drug development and production process.
Sterile filtration of complex injectables by Partha BanerjeeMilliporeSigma
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies.
As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable.
Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
Ranveer Sharma from the Department of Biotech at Bcet Gurdaspur presented on Panacea Biotec. Panacea Biotec is an Indian healthcare company focused on pharmaceuticals, biopharmaceuticals, vaccines and natural products. It has a global footprint in over 30 countries. Key highlights included its #4 ranking in vaccines in India, state-of-the-art manufacturing facilities approved by US FDA and WHO, and strategic collaborations with companies like Serum Institute of India and Apotex. Recent updates discussed a collaboration with Serum Institute on a hexavalent vaccine and a settlement agreement with Celgene regarding patents on Panacea's generic version of Abraxane.
Sovrin Plastics provides precision plastic injection moulding and contract manufacturing services for the medical, electronics, and engineering industries. They have over 45 years of experience as mould makers and precision injection moulders with 140 personnel, 52 moulding machines, and a 7,500 square meter facility. They specialize in manufacturing for the healthcare sector, with capabilities including drug delivery systems, diagnostics, surgical instruments, and implantable medical devices.
Vskills certification for Biopharmaceutical Professional assesses the candidate as per the company’s need for developing and managing biopharmaceuticals. The certification tests the candidates on various areas in types, sources of biopharmaceuticals which also includes methods of production and legal issues.
http://www.vskills.in/certification/Health-Nutrition-and-Well-being/Certified-Biopharmaceutical-Professional
This document discusses lubrication challenges with prefilled syringes and introduces TriboFilm Research's solutions. Silicone oil is commonly used to lubricate prefilled syringes but can migrate, causing inconsistent plunger forces and introducing particles into drugs. TriboFilm has developed an atmospheric plasma technology that can immobilize lubricants like silicone oil or its PFPE lubricant onto syringe surfaces, reducing lubricant migration issues. This plasma process crosslinks the lubricant during syringe manufacturing without contaminants.
This document discusses lubrication challenges with prefilled syringes and introduces TriboFilm Research's solutions. Silicone oil is commonly used to lubricate prefilled syringes but can migrate, causing inconsistent plunger forces and introducing particles into drugs. TriboFilm has developed an atmospheric plasma technology that can immobilize lubricants like silicone oil or its PFPE lubricant onto syringe surfaces, reducing lubricant migration issues. This plasma process crosslinks the lubricant during syringe manufacturing without contaminants.
This document is a curriculum vitae for Ramesh Chaudhari that summarizes his professional experience and qualifications. He has over 4 years of experience in formulation research and development. He currently works as a senior research associate and has previously worked as an officer of formulation and development. His areas of expertise include developing various dosage forms for regulated markets in line with cGMP guidelines. He holds an M.Pharm in pharmaceutics and has experience developing formulations for tablets, capsules, injections and semisolids.
This white paper aims to provide a comprehensive
overview of the CMC guidance by the U.S. Food and Drug
Administration and present a streamlined approach for
development and manufacture of nasal spray products
The Bioprocessing Summit
August 18-22, 2014 | Boston, MA
http://www.bioprocessingsummit.com
The Bioprocessing Summit brings together international leaders to discuss today's bioprocess issues from cell line
selection to bioproduction. The Summit provides practical details in a relaxed, congenial atmosphere that promotes information exchange and networking.
The Bioprocessing Summit continues to grow, and now comprises 12 distinct meetings in one event, including cell
culture, purification, bioproduction, quality, formulation, and novel biotherapeutic formats. The Summit also features small-group breakout discussions, networking in the busy exhibit hall, an extensive poster display, and an array of in-depth short courses and training seminars. For the full listing of speakers at this year's Summit, please click here.
This leading bioprocess meeting is hosted in Boston each summer along the lively and cosmopolitan harbor
waterfront. Hundreds of bioprocess professionals come together each year at the Summit to share practical
solutions for today’s laboratory challenges with researchers from around the world. Please visit the website www.bioprocessingsummit.com for more information and to register.
This document provides information about Poseidon Environmental Technology Co., Ltd., including its contact information, location, website, phone numbers, core capabilities, and services. The company focuses on research and development of membrane technology for water treatment and provides one-stop ultrafiltration membrane solutions and customized filter cartridge services to water purifier manufacturers. It aims to be a world-leading supplier of water filtration materials and strives for excellence in talent development and product quality.
This document discusses integration of prior knowledge in good manufacturing practices (GMP). It covers the animal and human trial process for new drug approval and generic drug approval. It also discusses ensuring quality of drugs through proper management of ingredients, manufacturing facilities, and processes. The document presents a case study on complaints regarding a drug product where the root cause was not properly investigated, resulting in a recall. It stresses the importance of thoroughly investigating quality issues and failures to ensure patient safety.
1. The document discusses dissolution method development for generic drug products, noting it is a critical tool for formulation development, getting waivers from bioequivalence studies, and ensuring quality after manufacturing changes.
2. It outlines the key steps in developing a dissolution method, including testing variants with different release characteristics, selecting a method with adequate discriminating power, determining bioavailability, and establishing dissolution specifications to ensure similar product performance.
3. Common deficiencies seen in applications are failing to demonstrate the method is discriminating, missing critical data on material attributes and process parameters, lack of data supporting acceptance criteria, and not submitting individual dissolution data.
Drug Delivery Systems Americas (2011) PpPiyush Patel
The two-day Drug Delivery Systems Americas conference in Boston will focus on the latest scientific research, manufacturing, and commercial opportunities in drug delivery systems. Key topics will include drug formulations for small molecules, proteins, peptides, and biologics; delivery technologies such as controlled release, nanotechnology, and biologics targeting; commercialization aspects including partnering, outsourcing, and regulations; and case studies. Over 20 industry leaders from companies including Novartis, Pfizer, Genzyme, and Abbott will present on challenges and innovations in developing advanced drug delivery technologies. Attendees will gain insights on enhancing bioavailability, managing product lifecycles, and identifying strategic partnerships in the growing field of drug delivery.
This document provides information about an upcoming conference on pre-filled syringes. It outlines the conference details including dates, location, key speakers from companies like Merck Serono and AstraZeneca. It also lists media partners, sponsors, and exhibitors. The document discusses the growing market for pre-filled syringes and challenges in the industry. It promotes the conference as a chance to learn about new developments, network, and address issues like drug compatibility and manufacturing processes. A pre-conference workshop on legal issues is also advertised.
2nd Pharmaceutical Anti Counterfeiting Americas (2011) PpPiyush Patel
This document provides information about the "2nd Pharmaceutical Anti-counterfeiting Americas" conference taking place on November 14-15, 2011 in Boston, USA. The conference will discuss combating counterfeit medicines and feature speakers from pharmaceutical companies and regulatory agencies. Attendees will learn about US policy updates, technologies for tracking pharmaceuticals, and best practices for supply chain integrity. Posters can be submitted by academic institutions, pharmaceutical companies, and service providers to share research results. The conference is aimed at professionals working in pharmaceutical supply chain security, anti-counterfeiting, brand protection, and related fields.
This document provides information about an upcoming conference on single-use bioreactors being held in London on November 1-2, 2012. The conference will feature speakers from pharmaceutical and biotech companies as well as equipment suppliers discussing topics such as using single-use bioreactors to increase flexibility, reduce costs and speed up research and development. Attendees will learn about case studies on scaling up production with disposable technology and accelerating cell culture development. The conference offers sponsorship and exhibition opportunities for companies to promote their services and products.
This investor presentation provides an overview of Viropro, Inc., a contract development and manufacturing organization for biotech drugs. It discusses the growing market opportunity in outsourcing biopharmaceutical R&D and manufacturing services. Viropro plans to build a global network through acquisitions like Alpha Biologics, which owns an FDA-compliant biomanufacturing facility in Malaysia. This "string of pearls" model across Asia and Europe is aimed to provide world-class development and manufacturing services to biotech companies in a cost-effective manner. The presentation makes the case that an investment of $40 million in Viropro over two funding rounds could yield a return of 10x and 46% IRR through an
This document provides an agenda for the "Aesthetics and Anti-Ageing" conference taking place on May 11-12, 2011 in London, UK. The conference will explore new developments in anti-aging therapies and latest technological advancements in aesthetic surgeries. Over the two days, keynote speakers will discuss topics such as changing market demands, innovations in facial rejuvenation surgeries, cosmeceuticals, fat stem cells, new technologies for delivering anti-aging agents to the skin, challenging surgical problems, platelet rich plasma, sports medicine, and more. The event is aimed at professionals in fields like pharmaceuticals, biotechnology, dermatology, anti-aging medicine, and aesthetic medicine.
Clinical Trial Logistics & Supply (2011) FbFateja
This document provides information about an upcoming clinical trial logistics and supply conference to be held in London on September 29-30, 2011. It lists key speakers from various pharmaceutical companies that will discuss topics like predictive drug supply modelling, bioequivalence studies, drug pooling strategies, quality assurance, and managing clinical trials in Eastern Europe. The document also provides details about sponsoring, exhibiting, and submitting poster presentations at the conference.
The document announces the 5th Annual Contract Manufacturing conference to take place on December 7-8, 2011 in London. It will address every aspect of outsourcing from selecting partners to regulatory issues. Key speakers include outsourcing managers from major pharmaceutical companies. Attendees will learn about emerging trends, selection criteria, partnership strategies, and regulatory frameworks. The conference aims to help pharmaceutical companies and contract manufacturers assess outsourcing strategies and opportunities.
This document announces the 5th Annual Stability Testing Conference to be held November 3-4, 2011 in London. The conference will bring together experts from pharmaceutical companies like Pfizer, GSK, Novartis, and others to discuss multiple facets of stability testing. Topics will include updates on guidelines, effective planning, methods, evaluation of results, challenges in biologics stability testing, and analytical testing methods.
This document announces the 11th Annual Biosimilars UK conference taking place October 29-31, 2012 in London. It will bring together major pharmaceutical companies, regulatory bodies, CROs, CMOs, and law firms to discuss strategies for competing in the complex biosimilars market. Key topics will include the latest regulatory guidelines, financial viability, patent strategies, approval pathways, legal issues, preclinical/clinical challenges, the roles of the US and European markets, pricing/reimbursement, and pharmacovigilance. The goal is to help participants maximize opportunities in this changing landscape. Major sponsors include Merck Millipore and United BioSource Corporation.
SMi's Pre-Filled Syringes Asia Pacific conference provides a fundamental analysis of the key growth drivers in the Asia-Pacific pre-filled syringes market. The conference brings together industry leaders to focus on opportunities and barriers to creating successful strategies in this emerging market. Register by March 31st to receive a $300 discount, or by April 28th to receive a $100 discount. The conference will take place on July 20-21, 2011 in Singapore and will include presentations and discussions on topics such as commercial opportunities, manufacturing, packaging, quality control, and regulatory trends related to pre-filled syringes in Asia-Pacific.
This document provides information about the 7th Annual Pharmacovigilance conference to be held on January 30-31, 2012 in London. The conference will discuss current pharmacovigilance regulations and strategies to improve drug safety, with key speakers from major pharmaceutical companies. Topics will include pharmacovigilance throughout a drug's lifecycle, risk management, safety surveillance, and new EU regulations. Attendees will gain insights on evaluating safety signals and benefit-risk assessments to increase drug safety.
This document provides information about an upcoming biobanking conference to take place on March 10-11, 2011 in London. It lists key speakers from companies like AstraZeneca, Bayer, and Sanofi-Aventis who will discuss topics like sample storage, biomarker discovery, and stem cell banking. The document also notes the growing market for biobanking and its importance for medical research. Sponsoring companies and media partners promoting the conference are also listed.
This document provides information about the 5th Lyophilisation conference to be held from September 7-9, 2011 in London. The conference will address key issues in lyophilisation process development and optimization. It will feature speakers from major pharmaceutical companies and contract manufacturing organizations. Attendees will learn about formulation characteristics, analytical technologies, process development, and engineering trends related to freeze-drying of pharmaceuticals and biologics. The conference is organized by Visiongain and will include workshops, presentations, panel discussions and opportunities for networking, exhibition and poster presentations.
The document provides information about the 5th Annual Recombinant Antibodies conference taking place from January 17-19, 2012 in London. It will feature presentations and workshops on advances in bispecific antibodies, next-generation monoclonal antibodies, and antibody translation. Key speakers will represent companies such as Roche, Novartis, MedImmune. Workshop topics will include antibody drug conjugates. The conference aims to provide networking opportunities and insights into improving antibody potency, engineering, development, and applications for cancer, inflammatory diseases, and more.
This document provides information about the "Pre-Filled Syringes Americas" conference taking place from March 31 - April 2, 2014 in Iselin, New Jersey. The conference will focus on the development, manufacture, and regulation of pre-filled syringe and injector devices in the Americas region. It will include presentations and panels from industry experts, as well as an exhibition and networking opportunities. Attendees will learn about topics like developing delivery systems for biologics, managing extractables and leachables, and gaining FDA approval. A half-day post-conference workshop on April 2nd will provide insight on accelerating regulatory approval of combination products.
The document discusses using a tobacco-based manufacturing platform for rapidly and cost-effectively producing vaccines and therapeutics. It outlines the business model, which involves licensing the technology to larger biotech companies, and describes initial customer feedback indicating the flu vaccine market may be difficult to enter but the therapeutics market, such as for alpha-1 antitrypsin, could be more promising. Prototyping efforts involve further characterizing alpha-1 antitrypsin production in tobacco plants.
This document provides information about the 6th Annual Pharmacovigilance Conference taking place on March 16-17, 2011 in London. The conference will discuss the latest developments in pharmacovigilance, drug safety, and risk management. It will feature keynote speakers from organizations like Pfizer, Abbott Laboratories, and Novartis. Sessions over the two days will cover topics like benefit-risk assessments, signal detection methodologies, pharmacovigilance during clinical trials, and the transition between pre- and post-marketing safety. The conference is aimed at professionals in fields like pharmacovigilance, drug development, clinical safety, and regulatory affairs.
Anteo Technologies - New York presentation 2015Matt Sanderson
- Anteo Diagnostics is an Australian biotechnology company that develops proprietary surface coatings called Mix&Go for use in healthcare, life sciences, and other industries.
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This document provides information about the 4th Annual Biomarkers conference taking place on December 1-2, 2011 in London. The conference will cover biomarkers from discovery through clinical trials and safety. Key speakers will discuss regulatory perspectives, novel biomarker targets, how biomarkers can accelerate clinical development, and more. Attendees will learn about improvements in biomarker technologies and analyses of biomarkers' role in drug development. Poster presentations are encouraged. The global biomarkers market was estimated at $13.5 billion in 2010 and is predicted to reach $33.3 billion by 2015, driving growth in the industry.
Similar to 2nd Prefilled Syringes Americas (2011) Pp (20)
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2nd Prefilled
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Syringes Americas
Examining the current market demand and developing safer, stable, cost-effective pre-filled syringes
April 5th - 7th 2011, USA BOOK NOW!
Key Speakers
Dr.Ingrid Markovic,Expert Review Scientist , Food and Drug Administration
Pankaj Paranjpe, Manager, R&D Operations, Bristol-Myers Squibb
Jennifer Johns, Principal Packaging Engineer, Bristol-Myers Squibb
Amanda Wolf, Scientist - Pharmaceutical Research and Development, Pfizer
Crisanta Ransom, MS&T - Commercialization Technical Center, Eli Lilly
Raul Soikes, Sr. Director Program Management, Baxter BioPharma Solutions
Dr. Jan Jezek, Chief Scientific Officer, Arecor
Jim Spolyar, Sales and Technical Director, SKAN US
Stephen A. Barat, Director, Toxicology and Operations, Forest Research Institute
Vinod Vilivalam, Director, West Pharmaceutical
Dr. Arno Fries Director Product Management Tubular Glass, Gerresheimer Bünde
Dr.Silke Conrad, Manager Regulatory Affairs, Ypsomed AG
Patty Kiang, Consultant, Kiang Consultant Services
Pre-conference Workshop, Tuesday April 5th 2011
Develop syringe materials and components that minimize and eliminate: contamination from leachables and extractables
Led by: Dr. Patty Kiang, PhD, Consultant, Kiang Consultant Services
Associate Sponsor
Driving the Industry Forward | www.futurepharmaus.com
Organised By
Media Partners
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/pfsamericas
2. Conference Introduction
2nd Prefilled Syringes Americas
April 5th - 7th 2011, USA
Dear Colleague,
ontinuous growth in vaccines, blood stimulants, therapeutic proteins,
C Poster Presentation
erythroproteins, interferons and rheumatoid arthritis has driven the growth of pre-
filled syringes market At a busy conference it is hard to make sure everyone who
ith promising growth of 10-15% per annum, there were 2 billion pre-filled syringe
W shares your interests knows what you are doing. Maximise
units sold in 2009 alone and expected to continue reaching 3.64bn units in 2015 your time at Visiongain’s 2nd Prefilled syringes Americas
and 6.83bn by 20251.
meeting by sharing your results in a poster presentation.
afety, stability, convenience and cost-effectiveness are main factors driving growth
S
With a plethora of key decision makers, take advantage of
of the pre-filled syringes market. Prefilled syringe manufacturers have had to
therefore respond to increasing demand, new requirements and more sophisticated this senior networking opportunity.
forms of drug delivery.
Please send your 200 word abstract, in English, to:
ollowing the success of visiongain’s previous pre-filled syringes conferences, we are
F info@visiongainglobal.com for approval. The deadline
proud to present the 2nd Pre-filled Syringes Americas conference.
for submissions is Monday, March 21st, 2011. Please include
t this global event of pre-filled syringes, meet industry leaders from around the
A
contact details for the corresponding author(s).
world to discuss every aspect of pre-filled syringes market from technological
needs, design to safety and quality through to regulatory issues. Spend three days in Academic institutions will not be charged a fee if booked as
partnering; participate in special panel discussions and evening networking drinks.
full-price delegates. Posters submitted by pharmaceutical
tay ahead of competition by learning about the latest developments on
S
and biotechnology firms will be charged a fee of £199.
technological advances in design, component materials, process engineering,
siliconisation, dosage accuracy, auto-injections, quality, safety and regulatory issues. Posters submitted by service providers / vendors are
welcome and will be subject to evaluation. Upon
By attending this conference, you will:
approval a fee of £500 will apply. Two delegates from
• ear about new technological developments and changing market scenario
H
your organisation must be booked at full price to present
• nderstand pharmaceutical industry expectations from manufacturers of pre-
U
a poster.
fillable syringes
• earn about recent achievements and trends for formulation and delivery of
L Please note that all posters will be displayed at the
protein pharmaceuticals, vaccines and blood stimulant drugs discretion of Visiongain Ltd and are subject to approval.
• ain insight about developments in the areas of component materials, surface
G Due to limited space, please register your interest early.
treatments and filling processing and packaging
• vercome challenges in prefilled syringes design, liquid viscosity, injection speed/
O
flow rate, needle inner diameter, needle length etc
• xplore auto-injection devices: convenience items, or a key component of
E Who will attend?
injectable products
• ptimize siliconization with regard to product requirements, autoinjector
O Vice/Presidents, Directors, Heads of:
compatibility, general syringe performance
• Packaging
• iscover about applications & advantages of bubble-free filling for today’s
D
parenteral products • Labelling
• evelop syringe materials and components that minimize and eliminate:
D
contamination from leachables and extractables
• Manufacturing
• tay ahead by learning about Ingenious advanced labelling technologies, including
S • Product design
peel off tabs and radio frequency transmitters, to increase product safety and
security • Technical support
• eview current state of art and future technological developments in the field of
R • Drug product process development
RABS, isolators, e-beam and alternatives
• xamine factors and recent developments in processing syringe nests
E • Drug device process development
• valuate benefits and challenges of outsourcing
E • Pharmaceutical sciences
• ssess the impact of new post-market surveillance regulations on pre-filled
A
medical devices • Safe medication practice
• btain the latest market analysis, and meet manufacturers showcasing their
O • Drug discovery & delivery
leading products
• Strategic alliances
I look forward to meeting you at the conference
• Clinical product resourcing
Best regards
• Supply outsourcing
• Contract management
• Process development
Sonia Tomar • Investment and venture capital
Conference Producer
1
Pre-Filled Syringes and Related Systems: World Market Outlook 2010-2025
3. Pre-Conference Interactive Workshop
2nd Prefilled Syringes Americas
Tuesday April 5th 2011
Develop syringe materials and components that minimize and
eliminate: contamination from leachables and extractables
Led by: Dr. Patty Kiang Timings: 9:30 - 10:00 Coffee & Registration
0
Consultant 10:00 - 17:00 Workshop
Kiang Consultant Services T
iming includes lunch and refreshment breaks
Workshop Agenda: About your workshop leader:
The objective of this workshop is to provide the information Dr. Patty Kiang
of critical factors which will impact the success of the prefilled Patty H Kiang, Ph.D. is a Pharmaceutical Consultant on
syringe development. The material composition, component / Pharmaceutical packaging and delivery devices for liquid and
lyophilized products, Prefilled syringe system, and CMC filing
device design, manufacturing and sterilization processes are
for Combination Products.
all the important factors which will impact the extractables
Prior to the consultant position, she was Account Director for Catalent Pharma
and leachables from the syringe system. Improved glass syringe Solutions; she was responsible for business development of Analytical & Biotech
operation and COC resin or Daikyo CZ resin syringes plus Services to Biotech and Pharmaceutical companies on the West Coast of USA,
Canada and Asia pacific territory.
Fluorocarbon film laminated plungers have demonstrated the
She was Head of Device Development for Genentech Inc. in South San Francisco,
reduction of contamination from extractables and leachables will
CA. She was responsible for the development of a new autopen injector for
be discussed in the workshop Growth Hormone; she was also responsible for setting up the Extractable /
Leachable program for evaluation of primary container/closure systems and
was a CMC leader for a prefilled syringe drug development. Prior to joining
Genentech, she was Director, Delivery Device and Packaging Support for
N
EW
Schering Plough, in Kenilworth, NJ. She was responsible for the development
RE
Pre-Filled Syringes and Related Systems: of PEG-Interferon dual chamber pen injector and various delivery devices. Prior
PO
World Market Outlook 2010-2025
RT
to joining Schering Plough, she was Director of Technology Development for
– how will rising demand and technological West Pharmaceutical Services in Lionville, PA, a developer and manufacturer of
developments create opportunities?
parental drug packaging components, where she coordinated with corporate
The market for pre-filled syringes has achieved growth partners in Japan and Germany in the development of various new products.
in recent years. In 2009, an estimated 2 billion pre-
filled syringe units were sold and the market for that She was a member of the faculty of the PDA’s Training and Research Institute,
technology was estimated to be worth up to $2.5 where she taught courses on Parenteral Packaging, and served as a member
billion. There is a trend towards pre-filled drug injection
of USP’s Expert Committee on Drug Packaging, Storage and Distribution. She
systems, away from vials/ampules, for both new and
existing products. Examples are filled glass and plastic was the chairperson for PDA Gamma Radiation Sterilization of Polymeric
syringes, pens and low-volume auto-injection devices, Materials Committee. She is an expert in the area of drug and container/closure
including refills. That sector has shown growth of
interactions and compability issues.
10-15% in recent years, forming one of the fastest-
expanding sectors in the pharmaceutical industry. In our She is a frequent speaker and has chaired many symposia on the packaging of
new report, we predict that the pre-filled drug delivery pharmaceutical and biotechnology derived products. Most recently she chaired
market will grow steadily from 2010, as the number
of products launched in pre-filled injectable forms the PDA 2006 Global Prefilled Syringe & Injection Device Conference. Dr. Kiang
increases. Medical professionals, patients and other holds five patents in the field of polymeric surface coatings. She received a Ph.D. in
stakeholders see the benefits of that more-convenient Analytical Chemistry from Villanova University and holds an MBA from Pennsylvania
system, raising demand at the expense of older formats.
State University.
4. Day 1
2nd Prefilled Syringes Americas
Wednesday April 6th 2011
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the chair 13:40 Overview of drug delivery devices for pre-filled
Pankaj Paranjpe syringe products
Bristol-Myers Squibb • User Benefit
• A new generation of device and compromises in device design
Jennifer Johns
• Aseptic pre-filled drug-delivery systems
Bristol-Myers Squibb
• Future opportunities
09:40 Update on pre-filled syringes: trends, materials,
14:20 Sponsor Spotlight Session
components, processes and quality
T
ake this unique opportunity to be a part of the conference theme,
• Market dynamics and trends
network, share ideas and provide an overview of your product/services
• New syringe materials
to the audience.
• Value added components
For more information please contact ronald.magali@visiongainglobal.com
• Syringes for biotech drugs
• Quality aspects
Dr. Arno Fries
15:00 Afternoon Refreshments
Director Product Management Tubular Glass
Gerresheimer
15:20 Panel discussion: New technological developments
and changing market scenario
10:20 Recent trends in the application of plastic prefillable
P
anlists will discuss the market trends and emerging requirements, latest
syringe systems for biopharmaceutical drug delivery developments in all areas of pre-filled syringe product development; from
• yclic olefin polymers: properties, applications and commercial drug products
C formulation to manufacturing, considerations for component and system
• ecent trends in the use of newer plastics for delivering mAbs,
R selection, supplier role in quality for any questions or participation please
proteins and vaccines contact sonia.tomar@visiongainglobal.com
• olve challenges associated with glass prefilled syringes, including
S
breakage reactivity and leachables like silicone, tungsten and glue
• arket and scientific needs for plastic prefillable syringes for
M
biopharmaceutical drugs and high viscosity formulations 16:00 Advanced formulations of biologics
• lastic vials for break resistant, less reactive and cold temperature
P • Stability of biologics
storage/transport containers for biologics and stem cells • Stable aqueous formulations for pre-filled syringes
• Reduced rate of aggregation
Vinod Vilivalam • High concentrations of antibodies
Director • Terminal sterilization by gamma radiation or e-beam
West Pharmaceutical
Dr. Jan Jezek
Chief Scientific Officer
Arecor Limited
11:00 Morning refreshments
16:40 Closing remarks from the chair
11:20 Rational selection of primary packaging components
for pre-filled syringe products
• Primary packaging components
• Packaging and drug delivery trends 16:50 Networking Drinks
• Developing primary and critical secondary packaging components Take your discussions further and build new
relationships in a relaxed and informal setting.
12:00 Fill-finish for prefilled syringes in a contract
manufacturing setting with the following emphasis
N
EW
• lient Teams dedicated to your product – relentless focus on your product
C Pharma Business Daily
SL
by knowledgeable individuals
ET
Each issue of Pharma Business Daily newsletter focuses on latest
• etrics to drive performance – leading indicating metrics; tangible output
M
TE
breaking stories in your market. Delivered directly to your Inbox or
R
translating to a timely deliverable available through the website, all the industry news is available to you
• CMO-Client partnership – conclusion highlighting best practices all the time. When you want the news its there for you - it really is that
simple. Over 25+ stories everyday as they happen. Never again will any
Raul Soikes of your colleagues be aware of news that you aren’t.
Sr. Director Program Management Plus exclusive features from visiongain conferences and in-depth
Baxter BioPharma Solutions analysis from visiongain analysts will be available to you thanks to your
subscription to PharmaBusinessDaily. This information is not available
anywhere else.
Call +44 (0)207 336 6100 or visit www.visiongain.com to sign up.
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011
5. Day 2
2nd Prefilled Syringes Americas
Thursday April 7th 2011
09:00 Registration and refreshments 13:40 Pre-filled syringe processing with RABS, Isolators,
E-beam & Alternatives
• Isolator technology with latest E-Beam design features
09:30 Opening address from the chair • Comparison of RABS vs Isolators
• Alternative tub entry system for slow speed production
• Expansion of the areas of application of syringe technology
Jim Spolyar
09:40 Extractables and leachables in pre-filled syringes
Sales and Technical Director
Dr. Ingrid Markovic SKAN US
Expert Review Scientist
Food and Drug Administration
14:20 Processing solutions for pre-filled syringes from
conditioning to aseptic filling and final assembly
10:20 How to select syringe components - Minimize • yringe conditioning including the processing steps washing, silicone
S
potential extractables and leachables coating, needle or needle shield assembly, nesting and packaging
• Tips to establish user requirements - Special topic: Features and challenges of the silicone coating process
• Examples of extractable/leachable failure modes experienced by industry • n-line washing and sterilizing solutions (for syringes without a glued-in needle)
I
• Risk based approach in evaluating extractables/leachables - pecial topic: Sterilizing tunnel for syringes with non-glass-to-glass
S
• trategy for selecting syringe components used for different drug products
S contact transport system
and coming from various sources • septic filling including the processing steps debagging, delidding, filling
A
and closing
Crisanta Ransom, Ph.D. - pecial topic: Vacuum filling and closing as well as in-process control
S
MS&T - Commercialization Technical Center (IPC) capabilities
Eli Lilly and Company • ssembly including the processing steps denesting, plunger rod assembly,
A
labeling, safety device assembly
- Special topic: Needle protection labels and safety devices
11:00 Morning refreshments Markus K. Hoersch
Technical Sales Manager
BAUSCH + STROEBEL
11:20 Toxicological risk assessment of leachable substances
from container-closure systems
• eneral background on leachables from container-closure systems
G 15:00 Regulatory issues relating to combination products
• egulatory expectations for the safety assessment of
R with delivery devices
leachable substances • Definition of “combination product”
• Current approaches to evaluate the potential for safety concerns • Regulatory paths for combination products / Primary Mode of Action
• orking examples to demonstrate how to conduct a
W • eCTD content planning for combination products with delivery devices
toxicological assessment • hallenges in eCTD content planning for combination products with
C
delivery devices
Stephen A. Barat, Ph.D.
Director, Toxicology and Operations Dr. Silke Conrad
Forest Research Institute Manager Regulatory Affairs
Ypsomed AG
12:00 Practical considerations for shipment of pre filled
15:20 Afternoon refreshments
syringes and experimental approaches taken
• Overview on practical consideration for shipment
• Shipping and handling charges
• Current practices in shipping and handling 16:00 Panel discussion: Evaluate benefits and challenges
of outsourcing
Amanda Wolf
Panelists will assess the importance of pharma-device alliances and design
Scientist
partnerships on pre-filled syringe products, discuss how to make most of the
Pfizer
partnership with contract manufacturers for any questions or participation
please contact sonia.tomar@visiongainglobal.com
12:40 Networking lunch
16:40 Chair’s closing remarks
16:50 End of Conference
6. Partners
2nd Prefilled Syringes Americas
April 5th - 7th 2011, USA
Associate Sponsor:
The BAUSCH + STROEBEL product range Sponsorship and exhibition opportunities:
specializes in machines for pharmaceutical
This event offers a unique opportunity to meet and do business
primary packaging, including equipment for
washing, sterilizing / depyrogenating, filling, closing and labeling with some of the key players in the pharmaceutical and biotech
of containers such as ampoules, cartridges, disposable syringes,
industries. If you have a service or product to promote, you can
vials and bottles of all kinds. Our systems are designed to comply
with the latest FDA and GMP requirements and are available for all do so at this event by:
capacity ranges, starting from laboratory testing and clinical batches
to fully integrated commercial production. With more than 40 years • Hosting a networking drinks reception
of experience and over 10,000 machines delivered BAUSCH +
STROEBEL is a leading manufacturer of high-quality equipment for • Taking an exhibition space at the conference
the pharmaceutical industry.
• Advertising in the delegate documentation pack
For further information please visit: www.bausch-stroebel.com
• Providing branded bags, pens, gifts, etc.
Media Partners:
PharmiWeb.com is the leading industry-sponsored If you would like more information on the range of
portal for the pharmaceutical sector. Supported sponsorship or exhibition possibilities for visiongain's
by most of the leading pharmaceutical corporations, PharmiWeb.
com provides dynamic real-time news, features, events listings and 2nd Prefilled Syringes Americas Conference,
international jobs to industry professionals across Europe and the US. please contact us.
For further information please email: corporate@pharmiweb.com
Ronald Magali, +44 (0)20 7549 9934
BIOTECHNOLOGY EUROPE is owned by
BIOTECHNOLOGY WORLD. It is based and located ronald.magali@visiongainglobal.com
in Warsaw, Poland. Biotechnology World was founded in 2007 to
provide the world’s biotech and pharma information and market to
make it universally accessible and useful for scientific and business
processes. Its first step to fulfilling that mission was building the
BIOTECHNOLOGY EUROPE platform that will allow a quick
spread of information in different channels. BIOTECHNOLOGY
About visiongain:
EUROPE offers companies completed internet public relations,
publication and marketing solutions. One of the mains goals of Visiongain is a specialist business information company focused on
BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma providing cutting edge products and services across the Pharmaceutical/
Sector in Europe to global biotechnology, pharmaceutical and life
Biotech, Telecommunications, Defence and Finance sectors, which
science activities.
For further information please visit www.biotechnology-europe.com include reports, conferences, online daily news and offline news
analysis and bespoke consultancy. With a commitment to innovation
InPharm is the online platform for exclusive
pharmaceutical news, comment, contracts, services, and excellence, visiongain offers flexible solutions to meet our clients’
jobs and events and is home to InPharmjobs.com, Pharmafile and business intelligence needs, providing the right information at the
Pharmafocus.
right time to facilitate the commercial decision-making process. Our
For further information please visit: www.In-Pharm.com
pharmaceutical products include Pharma Business Daily, the leading
Future Pharmaceuticals has forged powerful
Driving the Industry Forward | www.futurepharmaus.com
relationships with key industry leaders to provide a daily email newsletter for the pharmaceutical, biotech and healthcare
platform for successful brand recognition, and for senior decision- industries, and a range of independent, high-quality, in-depth reports
makers to have the means to procure and plan implementation covering focused and topical areas of concern. Our pharmaceutical
strategies based on the topics covered. Positioned to be an
authoritative resource within top pharma companies as well as conferences address the hottest commercial, regulatory and technical
small, specialty, and biotech, Future Pharmaceuticals magazine topics and provide an ideal forum for debate and networking for
is geared to create a deep penetration into a highly targeted and pharmaceutical professionals from around the world.
responsive audience, bridging the gap between the industries’ top
issues and the solutions top-tier vendors can provide. For further information, please visit: www.visiongain.com
For further information please visit: www.futurepharmaus.com
7. Registration Form
2nd Prefilled Syringes Americas
April 5th - 7th 2011, USA
Conf. code
Standard Prices
Conference and workshop Fee: £1699 (USD* 2629)
2nd Prefilled
Conference only
Workshop only
Fee:
Fee:
£1299
£599
(USD* 2010)
(USD* 927)
Syringes Americas
Number of bookings: Total cost:
April 5th - 7th 2011
*USD price is estimate only
USA
Promotional Literature Distribution
Distribution of your company’s promotional literature to all conference attendees
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