This document describes a study assessing the compatibility of a model monoclonal antibody formulation stored in glass vials and Blow-Fill-Seal (BFS) plastic vials. Several analytical tests were conducted to evaluate the stability, particle formation, aggregation, and leachables of the antibody formulation when stored in the two container types. The results showed no differences in potency, size exclusion chromatography profiles, or subvisible particle levels between the glass and plastic vial formats after 9 months of storage. Additionally, no significant leachables were detected from the BFS plastic container. Therefore, the study demonstrated comparable stability and compatibility of the monoclonal antibody formulation when stored in glass or BFS plastic vials.
This document discusses packaging options for pharmaceutical products. It begins with an overview of factors to consider when choosing the most appropriate packaging, such as protection, commercial needs, and regulatory requirements. It then covers specific packaging types like bottles, blister packs, and closures. Details are provided on material properties, barrier performance, and development considerations for stability and compatibility. The goal of establishing packaging "first intent" standards is also mentioned to streamline processes and ensure a robust supply chain.
This document discusses packaging options for pharmaceutical products. It begins with an overview of factors to consider when choosing packaging, such as protection, commercial needs, and regulations. It then covers specific packaging types like bottles, blister packs, inhalers and more. For each type, it lists material and design options. It discusses regulatory guidance for packaging from the US and EU. Finally, it covers approvals needed for packaging materials that contact pharmaceutical products.
This article introduces an oxygen transmission rate test method to test the pudding cup, i.e. the coulometric method. The test principle, instrument features, specifications, and testing procedures are all included in this article, which may provide reference for oxygen permeability test of packaging containers
This document provides an overview of the proceedings from an international symposium on food biotechnology held in May 1999 in Zakopane, Poland. It includes 17 volumes that cover a range of topics related to food biotechnology, including genetically modified organisms, food processing techniques, novel food products, measurement and quality control, and legal and social aspects of food biotechnology. The symposium brought together over 120 participants from academia and industry to discuss progress and challenges in applying modern biotechnology across the entire food chain. While significant advances have been made using biotechnology in food production, questions remain regarding consumer acceptance and the economic viability of some applications.
Same as human being food, pet food conforms to strict standards to ensure the safety of pets. Pet food must keep their original flavor and nutrition during maintenance, transportation and shelf life, which rely heavily on the pet food packages. In the keen competitions, prolonging pet food shelf life attracts more and more manufacturers and suppliers attentions. In this article, I will talk about the factors that affect pet food shelf life and related solutions to prolong shelf life in terms of pet food packaging.
Extractables from single-use bioreactors were found to negatively impact cell culture performance. Testing identified various extractable molecules, including degradation products of the antioxidant tris(2,4-di-tert-butyl-phenyl)phosphite. Bis(2,4-di-t-butyl-phenyl)phosphate (bDtBPP) in particular was shown to inhibit cell growth. The findings suggest controlling raw materials and manufacturing processes to minimize extractable contaminants that harm cells.
This document provides guidance for using algae beads to investigate photosynthesis and cellular respiration through an inquiry-based laboratory activity. It outlines the objectives of demonstrating CO2 movement during these processes and taking quantitative measurements. It describes the algae beads, which contain live algae cells, and a CO2 indicator solution for collecting qualitative and quantitative data. A sample procedure is outlined where students expose algae beads to light and dark conditions and monitor color changes in the indicator over time. Extensions and additional connections for further investigations are also discussed.
Soil dioxin concentrations in southern Alberta investigation presented at the San Antonio Dioxin 2010 conference. Examined concentrations and fingerprints of chlorinated dioxins and furans (PCDD/Fs) in soils sampled in rural areas in southern Alberta.
This document discusses packaging options for pharmaceutical products. It begins with an overview of factors to consider when choosing the most appropriate packaging, such as protection, commercial needs, and regulatory requirements. It then covers specific packaging types like bottles, blister packs, and closures. Details are provided on material properties, barrier performance, and development considerations for stability and compatibility. The goal of establishing packaging "first intent" standards is also mentioned to streamline processes and ensure a robust supply chain.
This document discusses packaging options for pharmaceutical products. It begins with an overview of factors to consider when choosing packaging, such as protection, commercial needs, and regulations. It then covers specific packaging types like bottles, blister packs, inhalers and more. For each type, it lists material and design options. It discusses regulatory guidance for packaging from the US and EU. Finally, it covers approvals needed for packaging materials that contact pharmaceutical products.
This article introduces an oxygen transmission rate test method to test the pudding cup, i.e. the coulometric method. The test principle, instrument features, specifications, and testing procedures are all included in this article, which may provide reference for oxygen permeability test of packaging containers
This document provides an overview of the proceedings from an international symposium on food biotechnology held in May 1999 in Zakopane, Poland. It includes 17 volumes that cover a range of topics related to food biotechnology, including genetically modified organisms, food processing techniques, novel food products, measurement and quality control, and legal and social aspects of food biotechnology. The symposium brought together over 120 participants from academia and industry to discuss progress and challenges in applying modern biotechnology across the entire food chain. While significant advances have been made using biotechnology in food production, questions remain regarding consumer acceptance and the economic viability of some applications.
Same as human being food, pet food conforms to strict standards to ensure the safety of pets. Pet food must keep their original flavor and nutrition during maintenance, transportation and shelf life, which rely heavily on the pet food packages. In the keen competitions, prolonging pet food shelf life attracts more and more manufacturers and suppliers attentions. In this article, I will talk about the factors that affect pet food shelf life and related solutions to prolong shelf life in terms of pet food packaging.
Extractables from single-use bioreactors were found to negatively impact cell culture performance. Testing identified various extractable molecules, including degradation products of the antioxidant tris(2,4-di-tert-butyl-phenyl)phosphite. Bis(2,4-di-t-butyl-phenyl)phosphate (bDtBPP) in particular was shown to inhibit cell growth. The findings suggest controlling raw materials and manufacturing processes to minimize extractable contaminants that harm cells.
This document provides guidance for using algae beads to investigate photosynthesis and cellular respiration through an inquiry-based laboratory activity. It outlines the objectives of demonstrating CO2 movement during these processes and taking quantitative measurements. It describes the algae beads, which contain live algae cells, and a CO2 indicator solution for collecting qualitative and quantitative data. A sample procedure is outlined where students expose algae beads to light and dark conditions and monitor color changes in the indicator over time. Extensions and additional connections for further investigations are also discussed.
Soil dioxin concentrations in southern Alberta investigation presented at the San Antonio Dioxin 2010 conference. Examined concentrations and fingerprints of chlorinated dioxins and furans (PCDD/Fs) in soils sampled in rural areas in southern Alberta.
This document discusses sustainable approaches to modern packaging materials and reducing their carbon footprint. It provides background on the managing director and their experience developing recycling plants and processes. It then discusses recent UK projects demonstrating recycled PET and HDPE in various applications. Finally, it summarizes opportunities in recycled polymers for the building industry and packaging while outlining research directions and cases studies.
Permanent Refreshment of Acetate Media - A story about passion on innovation....FIAT/IFTA
(1) The document discusses a new method developed by the NOA Research Department and the Austrian Research Institute for Chemistry and Technology to permanently refresh the elasticity of acetate film and other plastic media affected by "vinegar syndrome" through chemical treatment.
(2) The treatment increases the concentration of plasticizers in the material and can significantly slow or even stop further degradation, providing archives with more time before media need preservation and allowing for higher quality transfers with less resource-intensive climate control.
(3) Extensive testing was conducted to control the treatment process and verify its effectiveness through optical, mechanical, gravimetric and gas chromatography analysis, with the goal of commercializing the method.
The document outlines key topics in environmental microbiology including the roles of microorganisms like algae, fungi, and bacteria in the environment. It discusses optimal conditions for microbial growth and describes microbial growth curves. It also addresses microorganisms in various settings like water, food, waste, soil and their roles in nutrient cycles. The document concludes by covering management of microorganisms in healthcare facilities, universal precautions, disinfection techniques, and sterilization methods.
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This document provides an overview of Neha Roy's 6-day industrial training project report at Albert David Limited in Kolkata. It describes several departments and processes at the company, including their small volume parenterals production, tablet manufacturing, oral liquid preparation, quality control and quality assurance, reverse osmosis water plant, raw material storage, and bulk drug production. The report also acknowledges those who supported and guided Neha during her training placement.
This document discusses extractables and leachables from pre-filled syringes and their potential impact on biologic drug products. It defines extractables and leachables, outlines analytical techniques used to detect them, and provides examples of leachables detected from syringes that caused protein aggregation or covalent bonding. These included residual nylon, tungsten oxides, acrylate adhesives, and silicone oil. The document emphasizes that pre-filled syringes can contain various extractables and leachables from multiple sources, and that early collaboration with suppliers is important to develop a robust understanding and mitigate risks to drug product safety and quality.
“ NK & PP Túi ép tiệt trùng y tế – Găng tay y tế VN, Malaysia : Găng tay có bột, không bột (powder Free), Nitrile, Vinyl không bột, găng tay phẩu thuật tiệt trùng không bột- Vật tư khoa chống nhiễm khuẩn – Dung dịch tiệt khuẩn – Giấy gói y tế Crepe paper – Trang phục phòng mổ – Vật tư tiêu hao dành cho bệnh viện, phòng khám đa khoa, nha khoa, cty sx dược phẩm”
CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ ĐỈNH VIỆT
TSC: 132 Đường Số 18,Ấp 2, Xã Bình Hưng, Huyện Bình Chánh,TPHCM
MST: 0309797133
Tel : (848)22443084 – Mobile: 0909 39 68 38 – 0938 06 98 38 (Mr. Kiệt)
Web: www.tuihaptiettrung.com;www.tuihaptiettrung.vn ; www.dinhvietmedical.com
E-mail: dinhvietmedical@yahoo.com
Complete Information and knowledge about the selection criteria for packaging material and different test used for them .
All this material data is , Collected for seminar in QA SEM 2 , in the Subject of Pharmaceutical Manufacturing Technology .
Which also explain the How Quality control for Filling an pharmaceutical equipment is done.
The document discusses the scale-up of pharmaceutical products from the laboratory scale to a full production scale. It explains that the pilot plant plays an important role in transforming a formula into a viable product by developing a reliable manufacturing process. The document also provides details about specific processes for scaling up parenteral and oral liquid formulations, including necessary equipment and facilities as well as quality control measures.
Enviroment friendly qualittively responsive ethyl cellulose films as smart fo...soursdeysong
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2. The films were tested for properties like water absorption, color changes, and mechanical strength. Color changes indicated the films responded to changes in pH, showing potential as smart packaging to detect food deterioration.
3. Testing showed the dye-incorporated films had lower water absorption and responded mechanically when stretched, with the methyl orange film performing best. The films degraded safely and are a promising sustainable alternative to conventional plastic food packaging.
A CNT-based artificial nose for food spoilage detectionIRJET Journal
This document proposes a CNT-based artificial nose for detecting food spoilage. It would consist of a storage box with a carbon nanotube sensor on the cover that detects waste gases produced by bacteria as food spoils. When the CNT sensor detects spoilage-level gases, a light on the box would turn on to warn the user not to eat the food. The CNTs would act as a chemiresistor, changing resistance when exposed to waste gases. This would allow the sensor to quantify gas concentration and determine if the food is still safe to consume, helping prevent food poisoning. The CNTs would be deposited on the cover via spray technique to form the sensing layer.
This document provides an overview of the formulation and development of parenteral products. It discusses the key components including containers, closures, processing, formulation, production facilities, and evaluation methods. The production area is divided into five sections - cleanup, preparation, aseptic, quarantine, and finishing/packaging areas. Parenteral formulations contain active drugs, vehicles, and adjuvants. Finished products undergo sterility, clarity, leakage, pyrogen, and assay testing to ensure quality control.
This document is an instruction module for an Organic Chemistry course. It provides an introduction to organic chemistry and includes pre-tests and activities to help students learn. The module instructs students to complete pre-tests, activities, and a post-test to evaluate their understanding of key organic chemistry concepts and applications. It also lists various laboratory equipment commonly used in organic chemistry and their functions. The goal is to help students learn organic chemistry independently and continue their education amidst the COVID-19 pandemic.
This document provides instructions for a module on organic chemistry. It begins with an introduction to organic chemistry and reminders for using the module. It then includes a pre-test to assess prior knowledge on carbon and its compounds. The module contains activities like word puzzles and classification exercises to reinforce lessons. An evaluation post-test is included to assess learning. References are provided, and the module collects student information for coordination purposes. The overarching goal is to provide an independent learning experience on organic chemistry amidst the COVID-19 pandemic.
Optimization of Antimony Leaching From Food Packaging Covers Made Of Low Dens...IRJET Journal
This document describes a study that used response surface methodology to optimize conditions for leaching antimony from food packaging made of low density polyethylene. The study investigated the individual and interactive effects of pH, temperature, and retention time on antimony leaching efficiency. A central composite experimental design evaluated 20 experiments to derive a second-order model relating the response (antimony leachability) to the three variables. Analysis of variance showed the model had a high coefficient of determination. The maximum antimony leaching occurred under alkaline pH conditions, high temperature, and short retention time.
Southern Water and two industrial partners commend the University of Portsmouth's investment in its Environmental Technology Field Station facility. Southern Water says it will help develop strong partnerships and support training next-generation water engineers. Environmental Treatment Concepts is further developing anti-fouling and corrosion treatment technologies using the university's equipment. WPL has sponsored PhD students who conducted research at the facility on packaged treatment plants and developed a new treatment process.
sterilization and sterile manufacturinganand kakde
The container-closure system for parenterals includes:
- Containers: Made of glass or plastic that is chemically inert, pyrogen-free and does not interact or leach toxic substances into the product. Common types include ampoules, vials and prefilled syringes.
- Closures: Must provide a hermetic seal to prevent leakage and microbial contamination. Common closures include rubber stoppers, crimp caps, flip-off seals and plungers.
- Integrity testing: Container-closure systems undergo tests like leak testing, seal strength testing and particulate testing to ensure integrity is maintained during manufacturing, storage and transportation.
- Compatibility: The container and closure must be compatible
HPLC method devevelopment and validation.pptSaqibAli352940
The document discusses starting method development for LC-MS/MS in a public analyst laboratory. It provides an overview of resources for method development including literature, standards, proficiency testing programs and guidelines. It then presents examples of developing methods for semicarbazide in foods and melamine in foods, highlighting challenges overcome like availability of labeled internal standards and improvements in extraction methods that improved results.
The document summarizes a presentation about sustainability in the textile industry. It discusses current challenges around managing environmental, health and safety issues. It introduces the bluesign standard, which takes a holistic approach to sustainability by focusing on optimizing input streams and processes throughout the textile production chain. The standard aims to increase transparency, reduce resource usage, and move the industry towards best available technologies.
Penn Pharma provides pharmaceutical development, manufacturing, packaging, and consulting services. Their capabilities include formulation development, analytical testing, clinical trial supply, commercial manufacturing, and QP certification. They have facilities for tablets, capsules, liquids, and other dosage forms. Penn Pharma offers a full range of integrated services to support customers from pre-clinical development through commercialization.
How to Setup Default Value for a Field in Odoo 17Celine George
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This document discusses sustainable approaches to modern packaging materials and reducing their carbon footprint. It provides background on the managing director and their experience developing recycling plants and processes. It then discusses recent UK projects demonstrating recycled PET and HDPE in various applications. Finally, it summarizes opportunities in recycled polymers for the building industry and packaging while outlining research directions and cases studies.
Permanent Refreshment of Acetate Media - A story about passion on innovation....FIAT/IFTA
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Project report on industrial training at albert david ltd.Neha Roy
This document provides an overview of Neha Roy's 6-day industrial training project report at Albert David Limited in Kolkata. It describes several departments and processes at the company, including their small volume parenterals production, tablet manufacturing, oral liquid preparation, quality control and quality assurance, reverse osmosis water plant, raw material storage, and bulk drug production. The report also acknowledges those who supported and guided Neha during her training placement.
This document discusses extractables and leachables from pre-filled syringes and their potential impact on biologic drug products. It defines extractables and leachables, outlines analytical techniques used to detect them, and provides examples of leachables detected from syringes that caused protein aggregation or covalent bonding. These included residual nylon, tungsten oxides, acrylate adhesives, and silicone oil. The document emphasizes that pre-filled syringes can contain various extractables and leachables from multiple sources, and that early collaboration with suppliers is important to develop a robust understanding and mitigate risks to drug product safety and quality.
“ NK & PP Túi ép tiệt trùng y tế – Găng tay y tế VN, Malaysia : Găng tay có bột, không bột (powder Free), Nitrile, Vinyl không bột, găng tay phẩu thuật tiệt trùng không bột- Vật tư khoa chống nhiễm khuẩn – Dung dịch tiệt khuẩn – Giấy gói y tế Crepe paper – Trang phục phòng mổ – Vật tư tiêu hao dành cho bệnh viện, phòng khám đa khoa, nha khoa, cty sx dược phẩm”
CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ ĐỈNH VIỆT
TSC: 132 Đường Số 18,Ấp 2, Xã Bình Hưng, Huyện Bình Chánh,TPHCM
MST: 0309797133
Tel : (848)22443084 – Mobile: 0909 39 68 38 – 0938 06 98 38 (Mr. Kiệt)
Web: www.tuihaptiettrung.com;www.tuihaptiettrung.vn ; www.dinhvietmedical.com
E-mail: dinhvietmedical@yahoo.com
Complete Information and knowledge about the selection criteria for packaging material and different test used for them .
All this material data is , Collected for seminar in QA SEM 2 , in the Subject of Pharmaceutical Manufacturing Technology .
Which also explain the How Quality control for Filling an pharmaceutical equipment is done.
The document discusses the scale-up of pharmaceutical products from the laboratory scale to a full production scale. It explains that the pilot plant plays an important role in transforming a formula into a viable product by developing a reliable manufacturing process. The document also provides details about specific processes for scaling up parenteral and oral liquid formulations, including necessary equipment and facilities as well as quality control measures.
Enviroment friendly qualittively responsive ethyl cellulose films as smart fo...soursdeysong
1. A group of students at the Royal University of Phnom Penh developed environmentally friendly food packaging films using ethyl cellulose incorporated with pH indicator dyes.
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A CNT-based artificial nose for food spoilage detectionIRJET Journal
This document proposes a CNT-based artificial nose for detecting food spoilage. It would consist of a storage box with a carbon nanotube sensor on the cover that detects waste gases produced by bacteria as food spoils. When the CNT sensor detects spoilage-level gases, a light on the box would turn on to warn the user not to eat the food. The CNTs would act as a chemiresistor, changing resistance when exposed to waste gases. This would allow the sensor to quantify gas concentration and determine if the food is still safe to consume, helping prevent food poisoning. The CNTs would be deposited on the cover via spray technique to form the sensing layer.
This document provides an overview of the formulation and development of parenteral products. It discusses the key components including containers, closures, processing, formulation, production facilities, and evaluation methods. The production area is divided into five sections - cleanup, preparation, aseptic, quarantine, and finishing/packaging areas. Parenteral formulations contain active drugs, vehicles, and adjuvants. Finished products undergo sterility, clarity, leakage, pyrogen, and assay testing to ensure quality control.
This document is an instruction module for an Organic Chemistry course. It provides an introduction to organic chemistry and includes pre-tests and activities to help students learn. The module instructs students to complete pre-tests, activities, and a post-test to evaluate their understanding of key organic chemistry concepts and applications. It also lists various laboratory equipment commonly used in organic chemistry and their functions. The goal is to help students learn organic chemistry independently and continue their education amidst the COVID-19 pandemic.
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Optimization of Antimony Leaching From Food Packaging Covers Made Of Low Dens...IRJET Journal
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The container-closure system for parenterals includes:
- Containers: Made of glass or plastic that is chemically inert, pyrogen-free and does not interact or leach toxic substances into the product. Common types include ampoules, vials and prefilled syringes.
- Closures: Must provide a hermetic seal to prevent leakage and microbial contamination. Common closures include rubber stoppers, crimp caps, flip-off seals and plungers.
- Integrity testing: Container-closure systems undergo tests like leak testing, seal strength testing and particulate testing to ensure integrity is maintained during manufacturing, storage and transportation.
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HPLC method devevelopment and validation.pptSaqibAli352940
The document discusses starting method development for LC-MS/MS in a public analyst laboratory. It provides an overview of resources for method development including literature, standards, proficiency testing programs and guidelines. It then presents examples of developing methods for semicarbazide in foods and melamine in foods, highlighting challenges overcome like availability of labeled internal standards and improvements in extraction methods that improved results.
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dipesh-shah-catalent-pharma-solutions-usa.ppt
1. About OMICS Group
OMICS Group is an amalgamation of Open Access Publications
and worldwide international science conferences and events.
Established in the year 2007 with the sole aim of making the
information on Sciences and technology ‘Open Access’, OMICS
Group publishes 700+ online open access scholarly journals in
all aspects of Science, Engineering, Management and
Technology journals. OMICS Group has been instrumental in
taking the knowledge on Science & technology to the
doorsteps of ordinary men and women. Research Scholars,
Students, Libraries, Educational Institutions, Research centers
and the industry are main stakeholders that benefitted greatly
from this knowledge dissemination. OMICS Group also
organizes 1000+ International conferences annually across the
globe, where knowledge transfer takes place through debates,
round table discussions, poster presentations, workshops,
symposia and exhibitions.
2. OMICS International Conferences
OMICS International is a pioneer and leading science
event organizer, which publishes around 700+ open
access journals and conducts over 500 Medical, Clinical,
Engineering, Life Sciences, Pharma scientific conferences
all over the globe annually with the support of more than
1000 scientific associations and 30,000 editorial board
members and 3.5 million followers to its credit.
OMICS Group has organized 1000+ conferences,
workshops and national symposiums across the major
cities including San Francisco, Las Vegas, San Antonio,
Omaha, Orlando, Raleigh, Santa Clara, Chicago,
Philadelphia, Baltimore, United Kingdom, Valencia,
Dubai, Beijing, Hyderabad, Bengaluru and Mumbai.
4. Presentation Outline
1. Advanced Aseptic Delivery Technology: Blow-
Fill-Seal
2. General Requirements for Container
Qualification and examples of Protein-Container
Interactions
3. Case – Study: Compatibility assessment of a
model monoclonal antibody formulation with
AdvaseptTM and Glass vial
6. Quality/Sterility
Assurance
Minimizing
Particulates
Stability/
Compatibility
Reduce risk factors for
sterility challenges through
automation
Elimination of glass particles
and delamination with
significant reduction in
foreign particulates
Medical grade polypropylene
resin for excellent chemical
and physical properties
Advanced Aseptic
Filling Technology
Why Glass Free?
Safety/Reduced
Product Loss
Plastic construction
reduces risk of breakage
and simplifies opening
Advanced Delivery Technologies for Parenterals to
Mitigate Risk Associated with Aseptic Processing
7. Minimize Risk: Simplify the Process, Reduce Variables
In just 15 seconds, the
container is formed, filled and
sealed in ISO 5 aseptic
conditions
8. Minimizing Variables and the Footprint in Aseptic
Manufacturing
Traditional
Glass Vial Filling
Vials Stoppers
Blow Fill Seal
Sterilized Stopper
insertion for vials
Form
Fill
Insertion
Seal
Prequalified
Resin
Downstream
equipment
Utilizing the automated aseptic design of BFS, the technology eliminates
traditional manufacturing steps, reduces the required controlled space and
decreases the risk of contamination associated with traditional aseptic practices
Glass Vial Filling
Large controlled
space
Glass management
and process control
Blow Fill Seal
Class A space
10 sq. ft
Sterile container is
formed at the time of
fill
9. Leveraging Advanced Aseptic Process Blow Fill Seal
Technology
Reference: Verjans, B. Reed, C. (2012). “Assessing Filling Technologies for Contamination Risk.”
Biopharm International. 25(3), pp. 46-58.
The BFS process minimizes the risk of contamination by
reducing particles, process steps & human interaction
Potential risk of contamination by filling technology
based on air quality and exposure time
11. General Requirements for Container Qualification
Safety –
• Are we maintaining sterility?
• What are we leaching?
Efficacy –
• Are we adequately protecting the dose?
• Is there binding -- adsorption/absorption?
• Are we delivering the dose?
12. Container Interactions with Protein Therapeutics
Discussion Topics
1.What are the product development concerns
for container interactions with protein
products?
2.What testing is needed to understand
container interactions with protein
therapeutics?
13. Liquid Formulation Containers (Injectables)–
Potential Materials
Enhanced System Container Materials Closure Materials
Vials or Ampoules
(SVP)
Glass/AdvaseptTM Vials with Butyl
rubber/Teflon coated butyl
rubber
Prefilled syringes
with plungers
Glass or Plastic
Staked needle or luer lock
(plastic or rubber)
Butyl rubber
Teflon coated butyl rubber
IV Infusion (LVP) Glass/Flexible Bags with
spike ports/AdvaseptTM
Polyethylene
14. General Concerns for Protein-Container
Interactions
Container Concerns Product concerns
• Protein adsorption • Protein loss
• Headspace • Agitation causes protein aggregation
(AdvaseptTM Advantage)
• Organic leachables (eg.
Silicone, DEHP)
• Toxicity of leachable
• Protein aggregation/Immunogenicity
• *Trace metals (eg. Iron,
Tungsten, Aluminum)
• Eg. Iron – Iron Leachable catalyzed protein
degradation reactions
• Eg. Tungsten – Protein Oxidation
(AdvaseptTM Advantage)
• Eg. Aluminum – Aluminum Phosphate
resulted in visible particles (AdvaseptTM
Advantage)
*www.pqri.org/workshops/podp11/pdfs/markovic.pdf , “Regulatory perspective safety qualification of extractable and leachable,”
Feb. 22-23, 2011, Ingrid Markovic, Ph.D.
15. Challenges to fill Biologics with Blow-Fill- Seal
(BFS)
Challenges:
1. Impact of elevated temperature of the
molded plastic during filling on the stability
of the biologic formulation
2. Impact of gas permeation from semi-
permeable BFS plastic container on
degradation of biologics (for eg. Oxidation)
3. Impact of potential leachables from BFS
processed plastic container system on
biologic stability and safety of the
formulation.
17. Temperature Profile of solution
Conclusion: The molded plastic process was optimized by Catalent to reduce the temperature
of the solution (0.5 mL fill) close to 40°C at time of fill and the assumption is that the
temperature of the solution would fall steadily after the units come out of the fill suite and
packaged under ambient conditions.
18. Oxygen and Carbon Dioxide Gas Permeation Data
Conclusion: Carbon Dioxide has higher permeation rate
relative to Oxygen because Carbon Dioxide partitions into
the container to a greater extent relative to Oxygen.
0.0E+00
2.5E-02
5.0E-02
7.5E-02
1.0E-01
0 10 20 30 40
cc*mm/(cm
2
*day)
Temperature (C)
Gas Permeation Rate vs Temperature (Normalized)
Oxygen
Carbon
Dioxide
19. Water- Vapor Transmission Rates
0.0E+00
1.0E-05
2.0E-05
3.0E-05
4.0E-05
5.0E-05
5 10 15 20 25 30 35 40
g*mm/(mm
2
*day)
Temperature (C)
Water Vapor rate (normalized) vs Temperature (C)
Conclusion: Higher the Temperature, greater the water
vapor permeation rates
20. Case – Study:
Compatibility assessment
of a model monoclonal
antibody formulation with
AdvaseptTM and Glass
container system
21. Monoclonal Antibody Formulation Recipe +
Preparation
.
Table 1: Model mAb Formulation
Components Amount
(mg/mL)
Model mAb ( Mol.
Wt. 144 kDa)
10
Polysorbate 80 0.7
Sodium Citrate 6.5
Sodium Chloride 9.0
pH 6.5
The monoclonal antibody formulation was filtered with a 0.2 micron Nalgene filter unit
and filled in glass vials into which uncoated stoppers were placed. The mAb formulation
was filtered into a sterile bag and shipped to Blow-Fill-Seal (BFS) manufacturing facility.
The formulation was aseptically transferred in BFS AdvaseptTM
stoppered vials.
22. mAb Compatibility Assessments
(Glass/Advasept Vial formats)
Parameter Method Target Range
pH USP 791 6.5 + 0.3
Appearance Visual Inspection Report Results
Potency UV (280 nm) T=0 + 10%
Activity Report EC50
Stability
Size-Exclusion Chromatography
(SEC)
Report % Monomer and % High and low
molecular weights
Nanoparticle Tracking Analysis
(NTA)5 Report sub-micron particle size analysis
Sodium Dodecyl Sulfate-
Polyacrylamide Gel Electrophoresis
(SDS-PAGE)
Report % Area (HC +LC)
Capillary Isoelectric focusing (cIEF) pI (% of each peak)
Peptide Mapping2 % Chemical Modification
Leachables3
Polar Leachables (HPLC-UV) Report Irganox 1010 levels
Semi-Volatile Leachables (GC-MS) Report Aromatic Hydrocarbon levels
Volatile Leachables GC-FID Report Volatile Leachable levels4
Metals (ICP-MS) Report all metals except Na, I
Bacterial Endotoxin1 USP 85 Report Results
Bioburden1 USP 61 <10 CFU/mL
1 only performed at 0 time-interval
2 Only performed at 4 month time-interval
3 Only performed at 9M time-interval
4 Isopropyl alcohol, Methyl Ethyl Ketone, Trichloroethylene, Hexane, 2-methyl pentane, 3-methyl pentane, Methylcyclopentane,
Cyclohexane and Heptane
5 Performed on 12 M samples
23. Results 1 -Potency
Potency:
a) UV: The UV data indicates no apparent change in potency for both vial formats
upon pre and post-fill and upon storage to 9 months at 5°C were within target range.
b) Complement Dependent Cytotoxic Assay: The potency was determined using
responsive cell line in a complement dependent cytotoxic assay using a fluorescence
read out. Comparison of a dilution series with standard, formulation in glass and the
AdvaseptTM
vial were generated (Figure 1).
Figure 1: Dose Response Curve for model mAb formulation
x axis
0.001 0.01 0.1 1 10
0
1000
2000
3000
Graph#1
y = ( (A - D)/(1 + (x/C)^B ) ) + D: A B C D R^2
Advasept 2 (Advasept 2: Conc vs MeanValue) 3574.447 1.618 0.373 247.764 0.996
Glass vial 2 (Glass Vial 2: Conc vs MeanValue) 3511.099 1.729 0.482 325.305 0.998
Advasept 1 (Advasept 1: Conc vs MeanValue) 3534.978 1.711 0.391 320.817 0.998
Glass vial 1 (Glass vial 1: Conc vs MeanValue) 3568.287 1.728 0.46 338.779 0.999
Conclusions: The activity data
shows comparable potency values
between the Glass and AdvaseptTM
vials upon storage to 24M/5°C
(All data not shown).
24. Result 3 -Nanoparticle Tracking Analysis (NTA)
Particles AdvaseptTM
Glass Vial
D50 126 + 17.5 94 + 10.1 nm
D90 205 + 35 nm 144 + 13.4 nm
Total
Concentration
(particles/frame)
13.95 + 3.2 13.47 + 3.0
Total
Concentration
(particles/mL)
2.83e8
+ 6.5e7
2.74e8
+ 6.1e7
Mean sub-micron particle count data
(Nanoparticle Tracking Analysis)
for Monoclonal antibody formulations stored in
Glass and AdvaseptTM
vials for 12M/5°C.
Conclusions: Slightly higher size mode of aggregates were observed
in AdvaseptTM than in the glass vials, however, the total number of
particles are statistically comparable between the two container
closure systems.
25. Result 2 SEC-UV Aggregation Data
Conclusion: Stability data indicates higher levels of high
molecular weight species in Glass relative to AdvaseptTM vial.
0
1
2
3
4
5
6
0 6 12 18 24
%
High
Molecular
Weight
Species
Months
SEC-UV - Aggregation data (5C)
26. Results 4-Peptide Mapping Results
Type Sample % Modification
Oxidation Glass Vial 10.8
AdvaseptTM Vial 4.5
Deamidation Glass Vial 7.2
AdvaseptTM Vial 7.6
Conclusions: The oxidation levels were higher in Glass relative
to AdvaseptTM vials and could be attributed to mAb’s surface
interaction with glass surface causing more oxidation than in
plastic AdvaseptTM vials.
Procedure: Aged Glass and AdvaseptTM
vials (4M/5°C) were subjected to peptide
mapping by initially denaturing and reduction of the mAb with DTT, alkylation with
Iodoacetamide, followed by clean-up on a column, and digestion with Trypsin and
ASP-N. The peptides were separated on a UPLC column and UV and MS detectors
were employed. (Chromatograms provided in the appendix section).
27. Results 5 (pH, Appearance, cIEF and SDS-PAGE)
All other stability test results for parameters listed below were
comparable between Glass and AdvaseptTM vial formats.
1. pH
2. Appearance
3. cIEF
4. SDS-PAGE
Bioburden results performed at t=0 for both vial configurations
were below <10 CFU/mL.
28. Results 6 (Leachable Data Analysis)
The monoclonal antibody formulation samples stored for 9M at
5°C were analyzed for various leachables listed below:
1.Volatile: GC-FID
2.Semi-Volatile: GC-MS
3.Polar: HPLC-UV
4.Metal leachables: ICP-MS
Results: The leachable data indicates comparable leachable profile
for monoclonal antibody formulations stored in Glass and AdvaseptTM
vials except for Isopropyl alcohol. The Isopropyl alcohol content was
determined to be higher in Glass vial (14 mg/mL) relative to
AdvaseptTM vial (1.2 mg/mL) and was attributed to cleaning procedure
used for glass vials prior filling of the monoclonal antibody
formulation.
29. Conclusions
1. This study confirms compatibility of monoclonal antibody formulation
in glass and AdvaseptTM vial demonstrating plastic BFS vial suitability
for protein therapeutics.
2. Stability data indicates higher levels of high molecular weight species
in Glass relative to AdvaseptTM vial.
3. Affinity data indicates comparable potency levels in Glass and
AdvaseptTM vial.
4. Leachable data indicates comparable leachable profiles in Glass and
AdvaseptTM vial.
5. No significant differences were identified between Glass and
AdvaseptTM vials over the 9 months analyzed to date.
30. ACKNOWLEDGEMENTS
Catalent- Woodstock Catalent – Kansas City
1. Waiken Wong, Ph.D. 1. Vincy Abraham, Ph.D.
2. Bill Hartzel
3. Natasha Hults Catalent - RTP
4. Kay Schmidt 1. Thomas Luntz
2. Courtney Jones
Catalent – Madison 3. James Mclean
1. Gregory Bleck, Ph.D. 4. Vicki Wards
2. Ian J. Collins, Ph.D.
3. Process Development Team
33. cIEF Analysis
cIEF Chromatogram Time 0
a) Glass Vial b) AdvaseptTM
vial
Magnified Chromatograms Time 0
a) Glass Vial b) AdvaseptTM
vial
The chromatograms showed no comparable charge distribution between the Glass and AdvaseptTM
vial.
34. Impact of Elevated Temperature of the Molded Plastic
during filling on the stability of biologic formulation
T=0 data
Parameters Bulk Solution Glass Vial AdvaseptTM Vial
pH 6.4 6.6 6.6
Potency (UV)
(mg/mL)
10.8 10.8 10.9
SEC 2.2% High Mol. Wt.
97.8% Monomer
2.1% High Mol. Wt
97.9% Monomer
2.1% High Mol. Wt.
97.9% Monomer
SDS Similar Profile (Reduced/Non Reduced) Figures – Appendix section
cIEF Major PIs (%)*
pI Range 9.38-9.65 (7
peaks)
Major PIs (%)
pI Range 9.42-9.74 (8
peaks)
Major PIs (%)
pI Range 9.42-9.74 (8
peaks)
Conclusion: Data from stability indicating parameters between the bulk mAb, glass and AdvseptTM vial
drug product indicates that the BFS process is amenable to Biologics.
Peak pI % Area
1 9.38 11.0
2 9.40 14.0
3 9.45 11.9
4 9.50 34.0
5 9.56 3.49
6 9.59 20.7
7 9.65 5.0
Peak pI % Area
1 9.42 15.9
2 9.44 3.2
3 9.49 18.8
4 9.54 31.8
5 9.58 6.2
6 9.62 18.9
7 9.67 5.1
8 9.74 0.1
Peak pI % Area
1 9.42 15.8
2 9.44 3.1
3 9.49 18.6
4 9.54 31.9
5 9.58 6.2
6 9.62 19.1
7 9.67 5.3
8 9.74 0.2
*analysis occurred at separate time using different cIEF cartridge which may explain slight differences and
possible poor resolution of peak 8 which is only 0.1% of the total area. Peak profiles look similar.
cIEF (peaks)
35. SDS – PAGE Analysis
SDS-PAGE (Non-Reduced)
Lane 5 – Glass Vial
Lane 6 – AdvaseptTM
Vial
SDS-PAGE (Reduced)
Lane 5 – Glass Vial
Lane 6 – AdvaseptTM
Vial
38. Let us meet again..
We welcome you all to our future conferences
of OMICS International
2nd International Conference and Expo
on
Parenterals and Injectables
On
October 24-26, 2016 at Istanbul, Turkey
http://parenterals-
injectables.pharmaceuticalconferences.com/