This document announces a 3rd annual conference on lyophilisation in Europe taking place June 29-30, 2015 in London. It will focus on quality by design principles and process analytical technologies in lyophilisation as well as continuous improvement to ensure product quality. There will be keynote speakers from major pharmaceutical companies and a panel discussion on various topics. In addition, there are two half-day post-conference workshops on July 1st, one on spray drying and formulation and the other on quality by design in scale up.
SMi Group's 4th annual Lyophilisation Europe 2016 conferenceDale Butler
This document advertises an upcoming conference on lyophilisation (freeze drying) to be held in London from July 4-5, 2016. It provides an agenda for the two-day conference, listing topics such as designing robust freeze drying processes, continuous freeze drying, spray drying, and optimizing filling processes. It also advertises a half-day post-conference workshop on designing and scaling up a freeze drying process to be led by experts from NIBSC and Biopharma Process Systems. The document promotes the conference and workshop opportunities for professionals in lyophilisation, formulation development, bioprocessing and related fields.
SMi Group's 2nd annual Lyophilization USA 2016 conferenceDale Butler
This document summarizes a two-day conference on lyophilization taking place from April 27-28, 2016 in Iselin, New Jersey. The conference will discuss lyophilization technologies and techniques, with sessions on quality control, regulatory compliance, formulation, processing, and analytical methods. It will also feature two half-day workshops on April 29 on developing lyophilization cycles and tech transfer. The workshops will provide practical guidance on meeting QbD requirements and discuss challenges in developing lyophilized dosage forms.
This document outlines key aspects of innovation and technology. It discusses defining innovation, dimensions of innovation including ordinary and extraordinary types. It describes the steps involved in innovation including initiation, idea generation, evaluation and implementation. Driving forces for innovation that promote competitiveness are also presented. The document then covers technology, the approach dynamics of technology including inputs, processes, outputs and transfer. It concludes by discussing the important components of a technology package including feasibility, economic viability, know-how, room for innovation and environmental sustainability.
This document announces a two-day workshop on innovation best practices for the chemical industry to be held on July 28-29, 2011 in Shanghai. The workshop will be led by Dr. Shih-Lai Lu, a former chief scientist at 3M with over 20 years of experience developing new products. Attendees will learn about fundamentals of innovation, developing new product concepts, and managing innovation within their organizations. The agenda covers topics such as understanding customer needs, disruptive innovation, collaboration, and encouraging risk-taking.
This document provides an executive summary and career profile for Dr. B. Guruswamy, who has over 17 years of experience in API research, process development, scale up, and life cycle management in the pharmaceutical industry. He is currently a Senior Principal Scientist at Neuland Laboratories in Hyderabad, India, where he leads a team of 20 scientists in multiple projects related to API synthesis and process optimization. The summary highlights his educational background, roles and responsibilities, career achievements, areas of expertise, publications, patents, and research experience.
This document discusses modular solutions for community development from Eton Modular. It outlines Eton Modular's experienced team in modular construction project management and their manufacturing partner's modern manufacturing methods. Examples of Eton Modular's past projects are also provided, including for BHP, a hotel in the UK, and current projects in Papua New Guinea. The quality of Eton Modular's modular designs and manufacturing process is emphasized.
SMi Group's 4th annual Lyophilisation Europe 2016 conferenceDale Butler
This document advertises an upcoming conference on lyophilisation (freeze drying) to be held in London from July 4-5, 2016. It provides an agenda for the two-day conference, listing topics such as designing robust freeze drying processes, continuous freeze drying, spray drying, and optimizing filling processes. It also advertises a half-day post-conference workshop on designing and scaling up a freeze drying process to be led by experts from NIBSC and Biopharma Process Systems. The document promotes the conference and workshop opportunities for professionals in lyophilisation, formulation development, bioprocessing and related fields.
SMi Group's 2nd annual Lyophilization USA 2016 conferenceDale Butler
This document summarizes a two-day conference on lyophilization taking place from April 27-28, 2016 in Iselin, New Jersey. The conference will discuss lyophilization technologies and techniques, with sessions on quality control, regulatory compliance, formulation, processing, and analytical methods. It will also feature two half-day workshops on April 29 on developing lyophilization cycles and tech transfer. The workshops will provide practical guidance on meeting QbD requirements and discuss challenges in developing lyophilized dosage forms.
This document outlines key aspects of innovation and technology. It discusses defining innovation, dimensions of innovation including ordinary and extraordinary types. It describes the steps involved in innovation including initiation, idea generation, evaluation and implementation. Driving forces for innovation that promote competitiveness are also presented. The document then covers technology, the approach dynamics of technology including inputs, processes, outputs and transfer. It concludes by discussing the important components of a technology package including feasibility, economic viability, know-how, room for innovation and environmental sustainability.
This document announces a two-day workshop on innovation best practices for the chemical industry to be held on July 28-29, 2011 in Shanghai. The workshop will be led by Dr. Shih-Lai Lu, a former chief scientist at 3M with over 20 years of experience developing new products. Attendees will learn about fundamentals of innovation, developing new product concepts, and managing innovation within their organizations. The agenda covers topics such as understanding customer needs, disruptive innovation, collaboration, and encouraging risk-taking.
This document provides an executive summary and career profile for Dr. B. Guruswamy, who has over 17 years of experience in API research, process development, scale up, and life cycle management in the pharmaceutical industry. He is currently a Senior Principal Scientist at Neuland Laboratories in Hyderabad, India, where he leads a team of 20 scientists in multiple projects related to API synthesis and process optimization. The summary highlights his educational background, roles and responsibilities, career achievements, areas of expertise, publications, patents, and research experience.
This document discusses modular solutions for community development from Eton Modular. It outlines Eton Modular's experienced team in modular construction project management and their manufacturing partner's modern manufacturing methods. Examples of Eton Modular's past projects are also provided, including for BHP, a hotel in the UK, and current projects in Papua New Guinea. The quality of Eton Modular's modular designs and manufacturing process is emphasized.
This document provides an introduction and overview of basic computer concepts for a computer essentials course. It defines what a computer is, explaining that computers follow user instructions quickly as calculators. It also defines the components of a computer system and differences between hardware and software. Key concepts covered in 3 sentences or less include:
Computers consist of physical hardware that executes software instructions to perform tasks. Hardware includes input devices like keyboards and mice and output devices like monitors and printers. Memory and storage devices are also explained as important components for running programs and saving files.
This document discusses computers, data, information and communication technology (ICT). It defines a computer as a machine that processes data to produce information. Software provides instructions to computers. Computers have many advantages over humans like speed, accuracy and storage capacity. ICT relates to using electronic devices to create, store, transmit and retrieve information. Different types of ICT services and users are described. The document also discusses computer hardware, input/output devices, data storage, memory, networks and operating systems.
SMi Group's Lyophilisation USA 2015 conference & exhibitionDale Butler
This document advertises the 3rd Lyophilisation and Freeze Drying USA conference taking place on April 29-30, 2015 in Iselin, New Jersey. It provides an agenda for the two-day conference focusing on advances in lyophilization and freeze drying technologies. Topics will include quality by design strategies, process analytical techniques, cycle development optimization, and alternative drying methods. There will also be a half-day post-conference workshop on quality by design for lyophilization on May 1st. The conference aims to provide scientifically sound information on optimizing lyophilization processes for biologics and vaccines.
SMi Group's 3rd annual Lyophilization USA 2017 conferenceDale Butler
The document provides information about the 3rd Annual Conference on Lyophilization USA taking place from November 15-17, 2017 at the Renaissance Woodbridge Hotel in Iselin, New Jersey. The conference will feature presentations and workshops on topics related to lyophilization of biopharmaceutical products, including process development, scale-up strategies, quality by design principles, and more. Pre-conference workshops on November 15th will cover introductions to design of experiments and implementation of quality by design into lyophilization processes.
SMi Group's 11th annual Point of Care Diagnostics conferenceDale Butler
This document summarizes an upcoming two-day conference on point-of-care diagnostics taking place on October 27-28, 2014 in London. The conference will feature keynote speakers and panels discussing topics such as quality control of point-of-care testing, implementing point-of-care strategies, microfluidic technologies, and the future of point-of-care testing. Attendees can register online, by fax, phone, or mail. Early registration discounts are available before June 30 and July 18.
This document summarizes two half-day pre-conference workshops on November 15, 2017 prior to the "Lyophilization USA" conference on November 16-17, 2017. The first workshop from 8:30-12:30 is on "Implementation of Quality by Design principles into lyophilization processes" and will cover QbD in the context of lyophilization, determining the critical formulation temperature, and using PAT tools. The second workshop from 13:30-17:30 is an "Introduction to Design of Experiments" and will provide an overview of experimental design concepts and applications. Both workshops aim to educate attendees on optimizing lyophilization processes.
This document announces two half-day post-conference workshops on May 10, 2017 at the Copthorne Tara Hotel in London. The morning workshop from 8:30-13:00 is on "Getting the most out of DOE approaches during freeze drying development" and will cover fundamentals of lyophilization development and practical advice on design of experiments approaches. The afternoon workshop from 13:30-17:30 is on "Strategies to achieving process transfer in lyophilisation" and will discuss challenges in transferring lyophilization processes. Both workshops will include presentations, discussions, and case studies from industry experts.
Gathering a room of Senior Scientists and Heads of Pharmaceutical Engineering, the 5th annual show provides an ideal forum to discuss the latest advancements in pharmaceutical lyophilisation, welcoming regulatory guidance from the NIBSC-MHRA and expertise from the likes of Sanofi, Boehringer Ingelheim, Roche, Novo Nordisk and more!
This document provides information about the ISPE Singapore Conference and Exhibition on Continuous Improvement in the Life Science Industry taking place from June 22-24, 2014 at the Suntec Singapore Convention & Exhibition Centre. The conference will feature keynote speeches, workshops, and an exhibition on various topics related to pharmaceutical manufacturing. Attendees can choose from various packages including access to workshops, presentations, networking events, and plant tours. The conference is aimed at professionals working in areas such as biomanufacturing, facilities, quality assurance, and more.
This document provides an agenda for the 2nd Annual Conference on Highly Potent Active Pharmaceutical Ingredients taking place May 21-23, 2018 in London. The conference will address containment and cross-contamination issues related to HPAPIs. It will feature presentations and workshops on topics such as HPAPI project management, containment strategies, waste management, and regulations. Two half-day workshops on May 23rd will provide practical guidance on delivering HPAPI projects and preventing cross contamination and employee exposures. Over 150 professionals from pharmaceutical and biotech companies are expected to attend the conference.
This document provides information about an upcoming conference on lyophilization technologies. The conference will take place October 23-25, 2019 in Boston, USA, and include presentations from industry speakers and two post-conference workshops. Early registration discounts are available before May 31st, June 28th, and August 30th. The conference will explore topics such as lyophilization process development using quality by design approaches, continuous lyophilization of unit doses, monitoring techniques, and alternative drying technologies. Sponsorship opportunities are available for companies to promote their services to the lyophilization market.
SMi Group's Pharmaceutical Microbiology West Coast 2019 conferenceDale Butler
This document provides information about the Pharmaceutical Microbiology West Coast conference taking place June 4-6, 2019 in San Diego, CA. The conference will focus on bolstering contamination control strategies and maintaining microbial quality in pharmaceutical manufacturing. Over the two and a half days, the conference will include keynote speakers from major pharmaceutical companies discussing topics like contamination control, endotoxin testing, environmental monitoring, and strategies for special drug products. There will also be two pre-conference workshops on June 4th focusing on holistic approaches to microbial contamination control and endotoxins/impurities. The conference is aimed at microbiology, quality control, and manufacturing professionals working to ensure microbial safety in pharmaceutical and biotech facilities and products.
This document provides an introduction and overview of basic computer concepts for a computer essentials course. It defines what a computer is, explaining that computers follow user instructions quickly as calculators. It also defines the components of a computer system and differences between hardware and software. Key concepts covered in 3 sentences or less include:
Computers consist of physical hardware that executes software instructions to perform tasks. Hardware includes input devices like keyboards and mice and output devices like monitors and printers. Memory and storage devices are also explained as important components for running programs and saving files.
This document discusses computers, data, information and communication technology (ICT). It defines a computer as a machine that processes data to produce information. Software provides instructions to computers. Computers have many advantages over humans like speed, accuracy and storage capacity. ICT relates to using electronic devices to create, store, transmit and retrieve information. Different types of ICT services and users are described. The document also discusses computer hardware, input/output devices, data storage, memory, networks and operating systems.
SMi Group's Lyophilisation USA 2015 conference & exhibitionDale Butler
This document advertises the 3rd Lyophilisation and Freeze Drying USA conference taking place on April 29-30, 2015 in Iselin, New Jersey. It provides an agenda for the two-day conference focusing on advances in lyophilization and freeze drying technologies. Topics will include quality by design strategies, process analytical techniques, cycle development optimization, and alternative drying methods. There will also be a half-day post-conference workshop on quality by design for lyophilization on May 1st. The conference aims to provide scientifically sound information on optimizing lyophilization processes for biologics and vaccines.
SMi Group's 3rd annual Lyophilization USA 2017 conferenceDale Butler
The document provides information about the 3rd Annual Conference on Lyophilization USA taking place from November 15-17, 2017 at the Renaissance Woodbridge Hotel in Iselin, New Jersey. The conference will feature presentations and workshops on topics related to lyophilization of biopharmaceutical products, including process development, scale-up strategies, quality by design principles, and more. Pre-conference workshops on November 15th will cover introductions to design of experiments and implementation of quality by design into lyophilization processes.
SMi Group's 11th annual Point of Care Diagnostics conferenceDale Butler
This document summarizes an upcoming two-day conference on point-of-care diagnostics taking place on October 27-28, 2014 in London. The conference will feature keynote speakers and panels discussing topics such as quality control of point-of-care testing, implementing point-of-care strategies, microfluidic technologies, and the future of point-of-care testing. Attendees can register online, by fax, phone, or mail. Early registration discounts are available before June 30 and July 18.
This document summarizes two half-day pre-conference workshops on November 15, 2017 prior to the "Lyophilization USA" conference on November 16-17, 2017. The first workshop from 8:30-12:30 is on "Implementation of Quality by Design principles into lyophilization processes" and will cover QbD in the context of lyophilization, determining the critical formulation temperature, and using PAT tools. The second workshop from 13:30-17:30 is an "Introduction to Design of Experiments" and will provide an overview of experimental design concepts and applications. Both workshops aim to educate attendees on optimizing lyophilization processes.
This document announces two half-day post-conference workshops on May 10, 2017 at the Copthorne Tara Hotel in London. The morning workshop from 8:30-13:00 is on "Getting the most out of DOE approaches during freeze drying development" and will cover fundamentals of lyophilization development and practical advice on design of experiments approaches. The afternoon workshop from 13:30-17:30 is on "Strategies to achieving process transfer in lyophilisation" and will discuss challenges in transferring lyophilization processes. Both workshops will include presentations, discussions, and case studies from industry experts.
Gathering a room of Senior Scientists and Heads of Pharmaceutical Engineering, the 5th annual show provides an ideal forum to discuss the latest advancements in pharmaceutical lyophilisation, welcoming regulatory guidance from the NIBSC-MHRA and expertise from the likes of Sanofi, Boehringer Ingelheim, Roche, Novo Nordisk and more!
This document provides information about the ISPE Singapore Conference and Exhibition on Continuous Improvement in the Life Science Industry taking place from June 22-24, 2014 at the Suntec Singapore Convention & Exhibition Centre. The conference will feature keynote speeches, workshops, and an exhibition on various topics related to pharmaceutical manufacturing. Attendees can choose from various packages including access to workshops, presentations, networking events, and plant tours. The conference is aimed at professionals working in areas such as biomanufacturing, facilities, quality assurance, and more.
This document provides an agenda for the 2nd Annual Conference on Highly Potent Active Pharmaceutical Ingredients taking place May 21-23, 2018 in London. The conference will address containment and cross-contamination issues related to HPAPIs. It will feature presentations and workshops on topics such as HPAPI project management, containment strategies, waste management, and regulations. Two half-day workshops on May 23rd will provide practical guidance on delivering HPAPI projects and preventing cross contamination and employee exposures. Over 150 professionals from pharmaceutical and biotech companies are expected to attend the conference.
This document provides information about an upcoming conference on lyophilization technologies. The conference will take place October 23-25, 2019 in Boston, USA, and include presentations from industry speakers and two post-conference workshops. Early registration discounts are available before May 31st, June 28th, and August 30th. The conference will explore topics such as lyophilization process development using quality by design approaches, continuous lyophilization of unit doses, monitoring techniques, and alternative drying technologies. Sponsorship opportunities are available for companies to promote their services to the lyophilization market.
SMi Group's Pharmaceutical Microbiology West Coast 2019 conferenceDale Butler
This document provides information about the Pharmaceutical Microbiology West Coast conference taking place June 4-6, 2019 in San Diego, CA. The conference will focus on bolstering contamination control strategies and maintaining microbial quality in pharmaceutical manufacturing. Over the two and a half days, the conference will include keynote speakers from major pharmaceutical companies discussing topics like contamination control, endotoxin testing, environmental monitoring, and strategies for special drug products. There will also be two pre-conference workshops on June 4th focusing on holistic approaches to microbial contamination control and endotoxins/impurities. The conference is aimed at microbiology, quality control, and manufacturing professionals working to ensure microbial safety in pharmaceutical and biotech facilities and products.
SMi Group's 6th annual Pre-Filled Syringes conference & exhibition is already Europe's leading event. This year it will be better than ever. Check out the programme.
SMi Presents the 5th Annual Conference on
Pharmaceutical Microbiology 20 - 21 JAN 2016
Pioneering new techniques for the prevention
detection and management of microorganisms
SMi Group's Injectable Drug Delivery 2018 conferenceDale Butler
This document provides information about two half-day pre-conference workshops on injectable drug delivery taking place on May 15, 2018 in London. Workshop A from 8:30-12:30 will focus on creating a human factors and usability engineering file in accordance with FDA and IEC62366-1 standards. Workshop B from 13:30-17:30 will examine wearable injectors and their ability to meet clinical needs while reducing healthcare costs. Both workshops aim to equip attendees with practical knowledge and strategies for developing safer and more user-friendly drug delivery devices and technologies.
This document provides information about the 4th annual Biobanking conference taking place on June 23-24, 2014 in London. It includes the program agenda, speaker details, registration information and sponsorship opportunities. Some of the topics to be discussed are best strategies for using biosamples, enhancing sample quality, establishing biobanking structures, sample tracking and data management systems, ethics and regulation. Registration discounts are available by February 28th or March 31st.
This document provides information about the Pharmaceutical Microbiology UK conference, including workshops, being held January 21-23, 2019 in London. The two half-day post-conference workshops on January 23rd will focus on 1) setting up an effective environmental monitoring program and 2) developing a risk-based cleaning and disinfection program using rapid microbial methods. The conference will address current challenges and strategies in contamination control, regulations and trends for plasma-derived materials, environmental monitoring, and rapid microbial methods and alternative testing. It includes the agenda with over 20 speakers from leading pharmaceutical companies discussing case studies and best practices.
SMi Group's Pharmaceutical Microbiology USA 2017 conferenceDale Butler
This document provides information on the Pharmaceutical Microbiology USA conference happening on June 7-9, 2017 in San Diego. The conference will address current challenges in sterility assurance, environmental monitoring, and rapid microbial methods. It will feature presentations and panel discussions from industry experts on topics like challenges in microbial control, environmental monitoring trends, rapid microbial testing validation, data integrity, and contamination issues. Attendees can choose from pre-conference workshops on technologies for monitoring contamination control or microbial required use for terminal sterilization. The conference aims to evaluate the latest trends and opportunities in microbial control for pharmaceutical manufacturing.
P-161 Advances and Progress in Drug DesignWarka Ghirmai
This document provides information on the 15th annual conference on Advances and Progress in Drug Design taking place on February 15-16, 2016 in London. The conference will focus on optimizing protein-based drug discovery and biophysical tools to prioritize novel drug candidates. There will also be two interactive half-day post-conference workshops on February 17th focusing on molecular recognition from a dynamic perspective and analysis and application of ligand conformation in drug design. Speakers will include representatives from pharmaceutical companies such as Pfizer, AstraZeneca, Janssen, Roche, and Eli Lilly who will discuss topics like structure-based drug design using fragments, water mapping applications in drug design, and biophysical screening tools for compound validation
This document provides information on two pre-conference workshops at the "Superbugs & Superdrugs" conference on combating antimicrobial resistance.
The first workshop discusses rapid diagnostic tools for infectious diseases, focusing on tracking emerging infections, state-of-the-art diagnostic methods, mobile applications, and challenges in diagnosis.
The second workshop examines making materials like copper touch surfaces in healthcare settings to improve patient outcomes and reduce costs by lowering infection rates and antimicrobial resistance. It will evaluate the evidence for copper's antimicrobial efficacy and cost-benefit analysis.
This document summarizes a conference on RNA therapeutics. The conference will cover:
- Learning about pre-clinical and clinical developments in antisense oligonucleotide delivery and designing multifunctional nanoparticle carriers.
- Gaining insight into optimizing mRNA therapeutics and delivery methods, and understanding industry hurdles to targeted delivery beyond the liver.
- Featuring speakers from companies like Isis Pharmaceuticals, BioNTech AG, and Rigontech GmbH discussing topics like targeted delivery of antisense oligonucleotides, RNA vaccines, and modulating gene expression with oligonucleotides.
- Including workshops on next generation aptamer-conjugated RNA delivery and optimizing
P-158_Social Media in the Pharmaceutical Industry (Final)Warka Ghirmai
This document summarizes a two-day conference on social media in the pharmaceutical industry held on January 20-21, 2016 in London. The conference includes two pre-conference workshops on January 19th on becoming fully engaged in social media and using social media for pharma market research and business intelligence. The main conference over the two days will cover topics such as social media strategy, patient engagement, developing effective digital content, and building social communities. It provides an agenda with session details, speaker bios and registration information. The goal is to help pharmaceutical companies learn how to better utilize social media to engage with patients and other stakeholders.
This document provides information about two half-day post-conference workshops on November 12, 2015 following the Advances in Cell Based Assays conference on November 10-11, 2015. Workshop A will focus on the latest generation microscopes for live cell imaging in high-throughput, high-content, and high-content analytical assays, featuring an interactive session with Nikon, UK. Workshop B will explore applying tissue engineering to develop 3D cell-based assays, focusing on generating in vitro disease models, led by Associate Professor Felicity Rose. Both workshops aim to discuss cutting-edge technologies and their applications to advance cell and tissue-based screening assays.
This document provides information about the 4th Annual Conference on Cancer Vaccines to be held on September 16-17, 2015 in London. Professor Farzin Farzaneh of Kings College London will chair the conference. Key topics to be addressed include tumour genetic heterogeneity in immunotherapy, combination therapies to advance immune-oncology vaccines, and developments in targeted and personalized cancer treatments. There will be presentations from industry and academic leaders in the field.
This document provides an agenda for the 10th annual conference on Mitigating Drug Toxicities and Developing New Tools to Model Drug Metabolism to Strengthen Human Relevant Results (ADMET), taking place on June 29-30, 2015 in London. The conference will focus on topics such as in vitro models for detecting cardiotoxicity and hepatotoxicity, analyzing the performance of different in vitro models to detect hepatotoxic drugs, regulatory guidance on drug transporters, mitigating errors in early human dose predictions, and setting criteria for ADME endpoints. Speakers will discuss opportunities for modeling kidney disease and general toxicology studies, optimizing pre-clinical approaches and human relevance, population pharmacokinetics prediction and PK/PD
1. SMi Presents their 3rd Annual Conference on…
PLUS TWO HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 1st July 2015, Holiday Inn Regents Park Hotel, London, UK
A: Spray Dry and Formulation
Workshop leaders: Jim Bullock, Director, iFormulate Ltd
David York, School of Chemical and Process Engineering,
University of Leeds
8.30am - 12.30pm
B: Defining and implementing QbD
in the design space for Scale up
Workshop leader: Pierre Lebrun, Experienced Statistician
- Project Leader, Arlenda
1.30pm - 5.30pm
29-30
JUNE
2015Holiday Inn Regents Park Hotel, London, UK
Lyophilisation -
Europe
www.lyophilisationconference.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
BOOK BY 31ST MARCH AND SAVE £400
BOOK BY 30TH APRIL AND SAVE £200
BOOK BY 29TH MAY AND SAVE £100
CONFERENCE CHAIR:
Poul Bertelsen,
Principal Scientist, Takeda
KEY SPEAKERS INCLUDE:
• Yves Mayeresse, Director Primary and Secondary
Expertise, GSK
• Patrick Garidel, Head of Pharmaceutical Basic
Development, Boehringer-Ingelheim
• Eunice Costa, Process Development Engineer, Hovione
• Sune Klint Andersen, Principal Scientist, Novo Nordisk A/S
• Michael Dekner, Innovation Manager, Baxter Bioscience
• Edith Lecomte-Norrant, GPS Innovation & Technology &
Sciences Director, UCB BioPharma
WHY ATTEND THIS EVENT:
• Understand the fundamentals of freeze drying and
methods to optimise the process development
• Learn how to integrate risk-based approaches into QbD
principles
• Discuss strategies for improvement and areas of unmet
needs in our roundtable breakout session
• Gain new insight of spray-drying methodologies to
achieving continues –processing
• Strengthen understanding of how PAT can be applied in
lyophilisation.
@SMIPHARM
Protecting drug stability and optimising formulation
development through robust PAT and QbD principles
2. Register online at: www.lyophilisationconference.com • Alternatively
Lyophilisation - Europe
Day One I Monday 29th June 2015
Supported by
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Poul Bertelsen, Principal Scientist, Takeda
QUALITY BY DESIGN PRINCIPLES (QBD)
AND SCALING UP OF LYOPHILISATION
OPENING ADDRESS
9.10 Applying Quality by Design Principles (QbD) and risk
assessment
• ICH guidelines
• The QbD process
• QRM management including examples
Poul Bertelsen, Principal Scientist, Takeda
9.50 The basics of freeze drying
Patrick Garidel, Head of Pharmaceutical Basic
Development, Boehringer-Ingelheim
10.30 Morning Coffee
11.00 Keynote address: Implementation of
QbD in lyophilisation
• Improving flexibility and robustness of
the process design
• Quantitative performance measures to ensure product
quality
• Identifying stabilising excipients to ensure drug stability
• Evaluating risk factor of material attributes
Yves Mayeresse, Director Primary and Secondary Expertise,
GSK
11.40 Important considerations for scale-up
• From lab to large scale
• A generic approach to scale-up
• Challenges of scale up
Michael Dekner, Innovation Manager, Baxter Biosciences
12.20 Networking Lunch
1.30 Round table breakout session:
• Group introductions and discussion
of challenges met
• Examine opportunities to implement and
optimise the application of QbD principles
in process development.
• Share concerns, success stories and major areas for
improvement
MODELLING PROCESS DEVELOPMENT
2.10 Spray-drying process development and scale-up for
complex dosage forms: an alternative to lyophilisation
• A viable alternative for achieving continuous production
• Benchmarking lyophilisation with spray drying
• Challenges in spray drying process and formulation
development for complex dosage forms
• Maintaining product critical quality attributes across scales
• Case study: Scale-up of spray dried formulations
Eunice Costa, Process Development Engineer, Hovione
2.50 Crystal nucleation: Theory and modelling
• Classical nucleation theory
• Multi-step nucleation
• Molecular simulation of crystal nucleation
• Modulation of crystal nucleation using additives
Jamshed Anwar, Associate Dean for Research & Professor
of Computational Chemistry, Lancaster University
3.30 Afternoon Tea
4.00 The mechanical properties of lyophilised cakes
• The properties of mechanical properties of lyophilised
cakes are a potential QbD property
• Discussion: The mechanical properties of protein-based
lyophilized cakes
Daryl Williams, Reader in Particle Science, Imperial College
London
4.40 Panel discussion:
• Review PAT and QbD principles and discuss
current challenges facing scale up and
quality control
• Discuss opportunities for continuous lyophilisation
• Identify ways to bridge the gap between commercial and
laboratory lyophilisation
Panel leader: Yves Mayeresse, Director Primary and
Secondary Expertise, GSK
Panellists:
Eunice Costa, Process Development Engineer, Hovione
Michael Dekner, Innovation Manager, Baxter Biosciences
5.20 Chair's Closing Remarks and Close of Day One
Official media partner Leading media partner
Keynote
Presentation
3. fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Lyophilisation - Europe
Day Two I Tuesday 30th June 2015
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Poul Bertelsen, Principal Scientist, Takeda
PROCESS ANALYTICAL TECHNOLOGIES (PAT)
OPENING ADDRESS
9.10 Scale up methodologies for spray drying processes
• A viable alternative to achieving continuous production
• Optimising solution/suspension properties to maintain
critical quality attributes
• Challenges with atomization
• Case study: Spray drying of nanoparticles
Sune Andersen, Principal Scientist, Novo Nordisk A/S
9.50 Morning round table discussion
• How does PAT support scale up processes
and to what degree has it been successful?
• Discuss critical issues and major cost drivers
currently faced in scale up
• Discuss experiences with filing QbD reports and fulfilling
the requirements of PAT
10.30 Morning Coffee
11.00 The value of modelling in spray dried product development
• Understanding process influence and scale
• Predicting product structure and product quality
• Efficient approaches with models and experiments
Andrew Bayly, Chair in Chemical Engineering, Institute of
Particle Science and Engineering, University of Leeds
11.40 Engineering a continuous process to ensure
end product quality
• Controlling product structure and
homogeneity during freezing
• Process intensification and economic factors in scale up
• Integration with upstream and downstream operations
• Design for scalability and robust technology transfer
Bruce Williams, Managing Director, Williams Process Ltd
12.20 Networking Lunch
1.30 Enabling technologies in lyophilisation processes
• New approaches and robust technology transfer
• Recognising the need for and challenges of continuous
production in industry
• Case study
Andrew Tait, Postgraduate Research Engineer, Newcastle
University
CONTINUOUS IMPROVEMENT TO ENSURE PRODUCT QUALITY
2.10 Implementing QbD tools to optimise
product quality
• Integrating risk-based approaches
into QbD principles
• Maintaining continuous process
validation and control of process parameters.
• Case study on material flow
Pierre Lebrun, Experienced Statistician - Project Leader,
Arlenda
2.50 PAT on Pharmaceutical Processes
• Benefits of PAT in process development
• Implementing new technology in for PAT
Edith Norrant, GPS Innovation & Technology & Sciences
Director, UCB BioPharma
3.30 Afternoon Tea
4.00 Panel discussion:
• Application of Quality-by-Design to process
development
- Which steps are it most often applied to?
Is it relevant to apply it to all steps?
- How often is it used in IMPDs/CTAs?
- Experience with filing equations?
• Discuss the unique challenges facing design of experiments
• Future prospects for continuous production processes
• Critical issues and major cost drivers with technology
transfer in scale up
Panel leader: Sune Klint Andersen, Principal Scientist Novo
Nordisk A/S
Panellists:
Edith Norrant, GPS Innovation & Technology & Sciences
Director, UCB BioPharma
Bruce Williams, Managing Director, Williams Process Ltd
Andrew Tait, Postgraduate Research Engineer, Newcastle
University
4.40 Chair’s Closing Remarks and Close of Day Two
Want to know how you can get
involved? Interested in promoting
your services to this market?
Contact Teri Arri, SMi Marketing
on +44 (0) 20 7827 6162, or
email: tarri@smi-online.co.uk
Engineering
Spotlight
Keynote
Address:
Critical validation
processes and
risk-based QbD
4. HALF-DAY POST-CONFERENCE WORKSHOP A:
Wednesday 1st July 2015
8.30am - 12.30pm
Holiday Inn Regents Park Hotel, London, UK
Spray Dry and Formulation
Workshop leaders:
Jim Bullock, Director, iFormulate Ltd
David York, School of Chemical and Process
Engineering, University of Leeds
Overview of workshop:
Spray drying is an important manufacturing process for
pharmaceuticals and other formulated products. The
workshop will cover:
• What properties are needed in a spray-dried
formulated product?
• How are these properties measured?
• How can the formulation and process conditions be
designed to create the desired properties?
The workshop will include an overview of the science
behind spray drying, some relevant industrial examples as
well as an interactive group session.
Why should delegates attend this workshop:
Attendees will receive a valuable grounding in the
science and technology of spray drying and how this can
be used in designing formulations and using formulation
processes.
Programme
8.30 Registration and coffee
9.00 Opening Remarks
9.15 Spray drying principles
10.15 Modelling for spray drying
10.45 Coffee Break
11.15 Spray drying and formulated product properties
11.45 Interactive group session
12.15 Closing remarks
12.30 End of workshop
About the workshop leaders:
Dr Jim Bullock is co-founder and director of iFormulate
Ltd. Previously he was CEO of Intelligent Formulation Ltd
which promoted formulation technology in the UK.
After a D.Phil from Oxford, Jim led R&D projects in
imaging at Ilford Ltd and activities on crystal engineering
and dye formulation and chemistry at ICI/Zeneca. At
BASF, in UK and Germany, he headed formulation
development for colours and held marketing, strategy,
R&D and regulatory affairs functions for BASF’s global
biocides business and was also a board director of Agion
Technologies, USA.
Jim is co-director of the CPD course “Spray Drying and
Atomisation of Formulations”, run by the University of
Leeds.
David York holds the chair of Structured Particulate
Products in the department of Chemical Engineering and
is also Director of the High Value Chemical Manufacturing
hub which is focussed on increasing the interactions
between the university academics and industry to drive
research and impact. Part of this work included setting up
and managing the Strategic Partnership with P&G. He is
currently working with the KTN to help develop proposals
for a National Centre for Formulation and also sits on the
I ChemE Research Committee developing a strategy for
chemical engineering research in the UK.
David is a chemical engineer with 35 years’ experience in
industrial R&D inside P&G, has sat on the EPSRC Strategic
Advisory Network and chairs the Industrial advisory team
for UCL’s IMRC in Macro molecules. He is a visiting
professor at the Universities of Birmingham and Bristol and
is both a Fellow of the IChemE and the Royal Academy
of Engineering.
About the organisation:
iFormulate Ltd was founded to provide customised R&D
and innovation services to companies working in the field
of Formulation Science and Technology. We offer
consultancy, project management, idea generation and
development, assistance with commercialisation, market
and business development, training andevents.
www.iformulate.biz
5. HALF-DAY POST-CONFERENCE WORKSHOP B:
Wednesday 1st July 2015
1.30pm - 5.30pm
Holiday Inn Regents Park Hotel, London, UK
Defining and implementing QbD in
the design space for Scale up
Workshop leader: Pierre Lebrun, Experienced
Statistician - Project Leader, Arlenda
Overview of workshop:
• QbD –define, design, characterize, validate,
and monitor to meet the quality attributes
necessary for clinical performance
• Design Space, a (predictive) risk-based
approach
• Working in Phase I-III process validation
• Case studies, group - problem solving exercises
and interactive discussion
The workshop will include an overview of the
science behind spray drying, some relevant
industrial examples as well as an interactive group
session.
Programme
1.30 Registration and coffee
2.00 Opening Remarks
2.10 Session1: QbD applied to pharmaceutical
process
2.50 Session 2: linking CPP to clinical relevance
through process understanding
3.30 Coffee Break
4.00 Session 3: Case studies: beginning a QbD
analysis from development to process
valdiation
4.40 Session 4: Q/A + discussions
5.20 Closing remarks
5.30 End of workshop
About the workshop leader:
Pierre Lebrun has a master degree in computer
sciences and economy, followed by a master in
statistics at the university of Louvain-la-Neuve in
Belgium. Next, he completed his PhD in statistics in
2012 at the university of Liege (Belgium), in the
topic of Bayesien models and Design Space
applied to Pharmaceutical industry. Pierre is now
working for Arlenda, a Belgian company
specialized in biostatistics for pharmaceutical
development. Topics of interest include Quality by
Design, (bio) assay development, validation and
general statistics for the manufacturing and
release of drugs and vaccines, using effective
Design Space strategies.
About the organisation:
Arlenda is a company
specialized in advanced
clinical and non-clinical
statistics for the Pharma industry. Arlenda aims at
implementing QbD thinking, Bayesian thinking,
and modeling and simulations in perfect
accordance with the latest guidelines and
regulatory requirements. Arlenda also develops
softwares for the validation, transfer, and routine
of analytical and bio analytical assays, and for
stability studies.
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LYOPHILISATION - EUROPE
Conference: Monday 29th & Tuesday 30th June 2015, Holiday Inn Regents Park Hotel, London, UK Workshops: Wednesday 1st July 2015, London
4 WAYS TO REGISTER
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