Webinars
Planning and Executing a Media Fill: A Guide to Aseptic Process Validation for Lyophilized Products
11.04.20
Wednesday, November 4, 2020 | 11:00 AM EDT
Are you developing a biologic, biosimilar, or other complex drug product requiring lyophilization? Register for this webinar from Lubrizol Life Science to explore key considerations in designing and executing aseptic process simulations for lyophilized products, including a deep dive into study design, operational considerations, and regulatory guidance. Learn how robust validation can lead to commercial manufacturing success.
Key Learning Objectives:
- Explore the growth of aseptic lyophilization for biologics and complex drug products
- Discuss validation requirements and regulatory guidance for aseptic manufacturing processes
- Explain aseptic process simulation (AKA media fill) design and execution for lyophilized products
- Investigate common challenges and solutions when performing aseptic lyophilization—including operational considerations and real-world examples
- Understand how a well-designed validation strategy enables efficient aseptic lyophilization for the long-term
Speakers:
Dr. Karen Bossert
Vice President of Operations, Lubrizol Life Science Health – CDMO Division
Judy Cohen
Vice President, Quality Assurance, Lubrizol Life Science Health – CDMO Division
One Factor at a Time: Supporting ADC Process Characterization & Product Specification
10.29.20
Thursday, October 29, 2020 | 1:00 PM EDT
Piramal Pharma Solutions will present data from a simple OFAT experiment varying TCEP:mAb ratio to highlight the variability in distribution of species in some key assays supporting critical quality attributes of an Antibody Drug Conjugate. Piramal will discuss how this experiment can support product and process knowledge during product development (both early and late phase). We will aim to show how a small number of experiments can generate a large amount of data that is valuable to clients at key points during product development.
Speaker:
Allan Davidson
Head of Department, Analytical Development, Piramal Pharma Solutions
Why is the sterility of your drug product much more than just a test of sterility?
10.21.20
Wednesday, October 21, 2020 | 1:00 PM EDT
A lack of sterility and sterility assurance continue to be a significant reason for drug recalls and regulatory citations and can pose a very real risk to patient safety and public health. Sterilization is a pivotal step in the pharmaceutical drug development process to help ensure overall safety is maintained. In this presentation we will:
This information is meant to provide manufacturers with a better understanding of sterility to help them make the best decisions in regards to their specific drug product and relative patient safety.
Speakers:
Annick Gillet, Technical Director EO Pharma
Martell Winters, Director Scientific Competency
A lack of sterility and sterility assurance continue to be a significant reason for drug recalls and regulatory citations and can pose a very real risk to patient safety and public health. Sterilization is a pivotal step in the pharmaceutical drug development process to help ensure overall safety is maintained. In this presentation we will:
- Examine the goal and science of sterility assurance including the revision of AAMI ST67
- Introduce and contrast Terminal Sterilization and Aseptic Processing of drug products through a regulatory lens as well as that of a manufacturer
- Discuss modification strategies to consider in order to use Terminal Sterilization
This information is meant to provide manufacturers with a better understanding of sterility to help them make the best decisions in regards to their specific drug product and relative patient safety.
Speakers:
Annick Gillet, Technical Director EO Pharma
Martell Winters, Director Scientific Competency
Faster & Better, Your Success to IND & BLA Through S-CHOice Cell Line & 2-Step Purification Platform
09.15.20
NOW AVAILABLE ON-DEMAND
Expediting development timeline is directly related to obtaining IND clearance and starting phase 1 study faster. This webinar describes how you can get to IND faster through our accelerated & high performance proprietary cell line, S-CHOice; Samsung Biologics presents 3-month cell line development timeline and high-quality cell line. In addition, we will present the combined benefit with S-CHOice and 2-step purification platform, which can further expedite the timeline as well as reduction in manufacturing costs. We hope to share how our Faster & Better approach can be applicable to your molecule's successful development path to IND.
Speakers:
John Gill
Director of Cell Line Development
Beomkyu Kim
Lead Scientist of Downstream Process Development
How One CDMO Used an Innovative Technology to Overcome Viral Vaccine Production Challenges
08.18.20
NOW AVAILABLE ON-DEMAND
In modern medicine, vaccines are used to prevent or eliminate infectious diseases with exceptional impact in reducing mortality and morbidity rates around the globe. Unfortunately, vaccine developers often struggle to meet demand due to volume, leading many to turn to contract manufacturing and developing organizations (CDMOs) as a reliable partner for flexible vaccine production capacity.
As today’s CDMOs continue to see a spike in demand, they require innovative technologies to accelerate manufacturing, streamline process management, and decrease costs for customers. Structured fixed-bed bioreactors have proven to offer a reliable, scalable solution that increases flexibility while decreasing both cost and footprint.
Join us for a webinar on 18 August 2020 at 2pm EST to learn how Ology Biosciences is leveraging innovative bioreactor technologies and bioprocessing expertise to bring vaccine production to the next level. Case study results and expert insights will be shared on how to find success with adherent-cell growth profiles and viral performance to produce viral vaccines.
Speakers:
Alex Chatel
Product Manager at Univercells Technologies
Eric M. Vela
Executive Director of Process Development at Ology Bioservices
In modern medicine, vaccines are used to prevent or eliminate infectious diseases with exceptional impact in reducing mortality and morbidity rates around the globe. Unfortunately, vaccine developers often struggle to meet demand due to volume, leading many to turn to contract manufacturing and developing organizations (CDMOs) as a reliable partner for flexible vaccine production capacity.
As today’s CDMOs continue to see a spike in demand, they require innovative technologies to accelerate manufacturing, streamline process management, and decrease costs for customers. Structured fixed-bed bioreactors have proven to offer a reliable, scalable solution that increases flexibility while decreasing both cost and footprint.
Join us for a webinar on 18 August 2020 at 2pm EST to learn how Ology Biosciences is leveraging innovative bioreactor technologies and bioprocessing expertise to bring vaccine production to the next level. Case study results and expert insights will be shared on how to find success with adherent-cell growth profiles and viral performance to produce viral vaccines.
Speakers:
Alex Chatel
Product Manager at Univercells Technologies
Eric M. Vela
Executive Director of Process Development at Ology Bioservices
Give ‘Em a Hand! - A Happi Hand Hygiene Webinar
07.29.20
NOW AVAILABLE ON-DEMAND
Proper hand hygiene and surface cleaning have never been more important. This Happi webinar will look at this essential topic from several angles, including the jan/san market; new product development and efficacy testing.
Presenters:
Laura Mahecha
Industry Manager, I&I Cleaning Products, Kline & Company, Inc.
Andrea Lisbona
Founder and CEO, Touchland
Dr. James Kim
Vice President, Science & Regulatory Affairs, American Cleaning Institute
Sponsored By:
Proper hand hygiene and surface cleaning have never been more important. This Happi webinar will look at this essential topic from several angles, including the jan/san market; new product development and efficacy testing.
Presenters:
Laura Mahecha
Industry Manager, I&I Cleaning Products, Kline & Company, Inc.
Andrea Lisbona
Founder and CEO, Touchland
Dr. James Kim
Vice President, Science & Regulatory Affairs, American Cleaning Institute
Sponsored By:
Driving Operational Agility with Digital Quality Management
07.28.20
NOW AVAILABLE ON-DEMAND
Is the disconnected technology landscape slowing down operations and draining resources?
New-market demands, increasingly complex supply chains, and changing regulations will continue as the norm. Modern technologies can help manufacturers manage these external forces effectively, enabling them to be more agile, data-driven, and future-ready.
Today many manufacturers are digitizing quality management to increase operational agility and supply chain collaboration, meeting continually-changing market and customer demands.
Join Veeva experts in this webinar to learn how digitalizing quality management bridges gaps between manufacturing and quality management, improving cycle times and agility.
In this webinar, you will learn:
SPEAKERS:
Mike Jovanis - VP Vault Quality, Veeva Systems
Ashley Wentworth - Director, Vault Quality at Veeva Systems
Is the disconnected technology landscape slowing down operations and draining resources?
New-market demands, increasingly complex supply chains, and changing regulations will continue as the norm. Modern technologies can help manufacturers manage these external forces effectively, enabling them to be more agile, data-driven, and future-ready.
Today many manufacturers are digitizing quality management to increase operational agility and supply chain collaboration, meeting continually-changing market and customer demands.
Join Veeva experts in this webinar to learn how digitalizing quality management bridges gaps between manufacturing and quality management, improving cycle times and agility.
In this webinar, you will learn:
- About the opportunities to transform quality management
- How the right technology streamlines global quality processes, increasing automation and operational agility
- The industry best practices for driving successful digital transformation
SPEAKERS:
Mike Jovanis - VP Vault Quality, Veeva Systems
Ashley Wentworth - Director, Vault Quality at Veeva Systems
Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces
07.15.20
NOW AVAILABLE ON-DEMAND
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies. Spending more time on study design and development upfront will save valuable resources in the long run.
The goal of this presentation is to provide a general overview of disinfectant efficacy testing and to provide a detailed methodology to assist in designing coupon studies that accurately represent facility procedures. As we attempt to bridge the gap between laboratory conditions and environmental conditions, test method acceptance criteria and interpretation of coupon study results will also be discussed. Specifically, we aim to provide insight into how the results of a coupon study can be utilized to improve cleaning procedures.
What you’ll learn if you attend:
Speakers:
Hayden Booth - Study Director, Nelson Labs
Braxton Snarr - Study Director, Nelson Labs
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies. Spending more time on study design and development upfront will save valuable resources in the long run.
The goal of this presentation is to provide a general overview of disinfectant efficacy testing and to provide a detailed methodology to assist in designing coupon studies that accurately represent facility procedures. As we attempt to bridge the gap between laboratory conditions and environmental conditions, test method acceptance criteria and interpretation of coupon study results will also be discussed. Specifically, we aim to provide insight into how the results of a coupon study can be utilized to improve cleaning procedures.
What you’ll learn if you attend:
- Study Design – how to choose parameters that are representative of your facility while meeting regulatory expectations.
- Indications that initial or subsequent disinfectant efficacy testing needs to be performed.
- Interpretation of results – translating microorganism log reductions into useful information on the efficacy of facility cleaning procedures and disinfectants.
Speakers:
Hayden Booth - Study Director, Nelson Labs
Braxton Snarr - Study Director, Nelson Labs
Biopharmaceutical Process Characterization
06.11.20
NOW AVAILABLE ON-DEMAND
Laboratory scale process characterization provides in-depth process understanding and documentation of a manufacturing process needed to establish critical product and process parameters, determine proven acceptable control ranges and minimize the risk of manufacturing failures at production scale. Here we present process development and characterization strategies at Samsung Biologics required to support commercial scale manufacture of antibody therapeutics. The webinar will discuss approaches to demonstrate process understanding needed to develop a robust and scalable manufacturing process to support successful GMP manufacture of biologics.
SPEAKERS:
Kenneth Dawson Green
PhD / Senior Director, Manufacturing Science & Technology Team
Thomas Rene Gervais
PhD / Director, Manufacturing Science & Technology Team - Downstream
Laboratory scale process characterization provides in-depth process understanding and documentation of a manufacturing process needed to establish critical product and process parameters, determine proven acceptable control ranges and minimize the risk of manufacturing failures at production scale. Here we present process development and characterization strategies at Samsung Biologics required to support commercial scale manufacture of antibody therapeutics. The webinar will discuss approaches to demonstrate process understanding needed to develop a robust and scalable manufacturing process to support successful GMP manufacture of biologics.
SPEAKERS:
Kenneth Dawson Green
PhD / Senior Director, Manufacturing Science & Technology Team
Thomas Rene Gervais
PhD / Director, Manufacturing Science & Technology Team - Downstream
Pharma Packaging Considerations for Radiation Processing
05.20.20
Plus, a discussion on the new container closure integrity testing: Mass Extraction
NOW AVAILABLE ON-DEMAND
This webinar is designed to build your foundational knowledge of pharma packaging. The type and method of packaging is an important consideration for radiation processing using gamma and electron beam. This webinar discusses how product packaging and presentation (density, weight and product orientation) can affect routine processing. Examples will be presented about how certain considerations are taken into account when developing the product packaging to ensure an effective radiation sterilization process. The webinar will also cover mass extraction, a relatively new container closure integrity test which is included on the USP 1207 list of approved deterministic CCIT test methods. You will learn the basic methodology behind a mass extraction test, the advantages of mass extraction testing over other CCI methods, and how the test is performed.
Speakers:
Jennifer Gygi
Validation Specialist III / Technical Consulting Manager, Nelson Labs
John Schlecht
VP, Radiation Technical Services, Sterigenics
PRIME: A Knowledge-based Assessment Tool to Classify Pharmaceutical Processes
05.11.20
NOW AVAILABLE ON-DEMAND
The manufacturing of API is a long and complex process. The comparison between the different processes is not easy since the chemical structures vary and therefore the compounds physical properties also change.
In this webinar we will be presenting the tool we developed to be able to take advantage of 60 years of experience in developing API process. The use of this tool allows us to develop our clients' projects using a Development by Design approach and to better manage the expectations of different outputs at different lifecycle stages of the processes. This follows a structured approach which allows for a faster process development.
What can you learn from this webinar?
- How we score processes
- How the knowledge can be used to develop an API manufacturing by design
- How we can speed-up the process development.
Join this webinar where our speakers will share their views on this new tool that is able to accelerate the development process.
Speakers:
Rui Loureiro
Director, R&D Process Chemistry Development
Hovione
Filipe Ataíde
Senior Scientist, R&D Process Chemistry Development
Hovione
ICH Stability Testing and Method Development
04.22.20
NOW AVAILABLE ON-DEMAND
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle. Stability is part of a biotherapeutic’s quality target product profile, and results help analysts understand how critical quality attributes (CQAs) of both drug substances and products are influenced under specific conditions of temperature, relative humidity (RH), light, storage, pH, and other factors. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. This presentation will provide a brief overview of the ICH guidelines for Stability testing, as well as aspects of analytical method development.
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle. Stability is part of a biotherapeutic’s quality target product profile, and results help analysts understand how critical quality attributes (CQAs) of both drug substances and products are influenced under specific conditions of temperature, relative humidity (RH), light, storage, pH, and other factors. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. This presentation will provide a brief overview of the ICH guidelines for Stability testing, as well as aspects of analytical method development.
Speaker:
Shiri Hechter
Chemistry Senior Lab Operation Manager, M.Sc., ASQ CQA and CSSGB
Nelson Labs Fairfield
New Horizons in Formulation
03.24.20
NOW AVAILABLE ON-DEMAND
A Revolution in the Production of Mono-Dispersed Controlled Release Microparticles
Are existing technologies fit-for-purpose in terms of quality, control, efficiency and throughput volumes for manufacturing complex 21st century therapeutics? A new generation of proven, energy efficient, high volume membrane emulsification equipment, promises to be a game-changer for contract pharma. In this webinar you will learn:
Dr. James D. Oxley, Ph.D
Southwest Research Institute (SwRI) in San Antonio, TX, USA.
Sam Trotter MSc
Operations Manager at Micropore Technologies Ltd.
A Revolution in the Production of Mono-Dispersed Controlled Release Microparticles
Are existing technologies fit-for-purpose in terms of quality, control, efficiency and throughput volumes for manufacturing complex 21st century therapeutics? A new generation of proven, energy efficient, high volume membrane emulsification equipment, promises to be a game-changer for contract pharma. In this webinar you will learn:
- The enhanced therapeutic performance potential for emulsions, double emulsions and encapsulated particles in pharma applications with improved mono-dispersity;
- Why membrane emulsification offers significant advantages over both traditional homogenization and microfluidic processing; and
- Through specific case studies, how this new technology can significantly reduce or eliminate downstream processing steps with significant manufacturing savings.
Dr. James D. Oxley, Ph.D
Southwest Research Institute (SwRI) in San Antonio, TX, USA.
Sam Trotter MSc
Operations Manager at Micropore Technologies Ltd.
Serialization 2.0 – What’s Next?
02.12.20
NOW AVAILABLE ON-DEMAND
The road to serialization has been long and arduous for the pharmaceutical industry. Yet, there are still many hurdles to overcome in the next few years—saleable returns, line aggregation and interoperable data exchange just to name a few.
Additionally, industry experts now realize that serialization alone will not solve the ever-increasing global threat of counterfeited and diverted pharmaceutical products. The investments made to date on serialization are staggering and pharmaceutical companies are now looking to leverage these efforts to more effectively fight their supply chain and compliance issues.
Join us as we discuss the future of the pharmaceutical supply chain and review innovative technologies that will not only get us to the 2023 DSCSA deadline, but are changing the landscape for brand, product and consumer protection.
In this webinar we will discuss:
The road to serialization has been long and arduous for the pharmaceutical industry. Yet, there are still many hurdles to overcome in the next few years—saleable returns, line aggregation and interoperable data exchange just to name a few.
Additionally, industry experts now realize that serialization alone will not solve the ever-increasing global threat of counterfeited and diverted pharmaceutical products. The investments made to date on serialization are staggering and pharmaceutical companies are now looking to leverage these efforts to more effectively fight their supply chain and compliance issues.
Join us as we discuss the future of the pharmaceutical supply chain and review innovative technologies that will not only get us to the 2023 DSCSA deadline, but are changing the landscape for brand, product and consumer protection.
In this webinar we will discuss:
- Saleable Returns and VRS
- Secure tracking at the package level, including aggregation
- Why your drug distribution channel is still not safe
- Augmenting existing serialization solutions with innovative technologies
- Leveraging existing package labeling to fight supply chain threats
- Cost-effective solutions to prevent counterfeiting and diversion
Designing Auto-Injectors for Multiple Drug Viscosities
11.26.19
NOW AVAILABLE ON-DEMAND
The global injectable drug delivery market and, more specifically, the auto-injector market is booming. That growth is predicted to continue skyrocketing through the next decade. With such a huge market in play, and given the range of physical properties of drugs and biologics being administered via auto-injectors, it is crucial for pharma and biopharma industry OEMs to optimize device designs to be as adaptable, and thereby as cost-effective, as possible. Learn how to effectively partner with contract manufacturers and what design support they readily provide to you and your peers.
SPEAKER: Dave Philbrick
Dave Philbrick is Business Development Manager & Lead Product Engineer for Economy Spring, an MW Industries Company. For more than 38 years he has been involved in supporting new product development for medical instrumentation & drug delivery systems for Medical / Pharma OEM’s. He is a specialist in metal component development, design and integration.
The global injectable drug delivery market and, more specifically, the auto-injector market is booming. That growth is predicted to continue skyrocketing through the next decade. With such a huge market in play, and given the range of physical properties of drugs and biologics being administered via auto-injectors, it is crucial for pharma and biopharma industry OEMs to optimize device designs to be as adaptable, and thereby as cost-effective, as possible. Learn how to effectively partner with contract manufacturers and what design support they readily provide to you and your peers.
SPEAKER: Dave Philbrick
Dave Philbrick is Business Development Manager & Lead Product Engineer for Economy Spring, an MW Industries Company. For more than 38 years he has been involved in supporting new product development for medical instrumentation & drug delivery systems for Medical / Pharma OEM’s. He is a specialist in metal component development, design and integration.
