Webinars

One Factor at a Time: Supporting ADC Process Characterization & Product Specification

One Factor at a Time: Supporting ADC Process Characterization & Product Specification

10.29.20

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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 


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Why is the sterility of your drug product much more than just a test of sterility?

Why is the sterility of your drug product much more than just a test of sterility?

10.21.20

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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


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Faster & Better, Your Success to IND & BLA Through S-CHOice Cell Line & 2-Step Purification Platform

Faster & Better, Your Success to IND & BLA Through S-CHOice Cell Line & 2-Step Purification Platform

09.15.20

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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


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How One CDMO Used an Innovative Technology to Overcome Viral Vaccine Production Challenges

How One CDMO Used an Innovative Technology to Overcome Viral Vaccine Production Challenges

08.18.20

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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


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Give ‘Em a Hand! - A Happi Hand Hygiene Webinar

Give ‘Em a Hand! - A Happi Hand Hygiene Webinar

07.29.20

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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


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Driving Operational Agility with Digital Quality Management

Driving Operational Agility with Digital Quality Management

07.28.20

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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


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Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces

Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces

07.15.20

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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


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Biopharmaceutical Process Characterization

Biopharmaceutical Process Characterization

06.11.20

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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


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