Webinars

Container Closure Integrity and Stability Testing for Rigid Containers

Container Closure Integrity and Stability Testing for Rigid Containers

02.24.21

Wednesday, February 24, 2021 | 1:00 PM EST

Are you wondering how to set up a stability test plan for your vial product?  Are you confused at all the options for Container Closure Integrity Testing and wondering how to decide which one to choose for your product?  Then join us for a webinar on Stability and CCI testing.  We will outline the basics for setting up a stability test plan for rigid containers including aging conditions and testing frequency.  We will look at how probabilistic methods differ from deterministic methods and will discuss each of the common CCI test options outlined in USP 1207.  We will conclude with CCI method validation basics.

 

Agenda:
 

  • Stability Testing Basics
  • Probabilistic vs. Deterministic Test Methods for CCIT
  • Important Considerations for CCI Testing
  • CCI Test Method Validation Basics


Presenter: 
 

Jennifer Gygi, B.S., SM(NRCM)
Expert Technical Consultant, Nelson Labs


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Impact of Decentralized Trials in Oncology Drug Development

Impact of Decentralized Trials in Oncology Drug Development

02.09.21

Tuesday, February 9, 2021 | 11:00 AM EST

Innovative precision therapies are having a significant impact on oncology drug discovery and treatment for patients with rare tumors. Recognizing that these patient populations can be limited as well as the unique ability of new therapies to improve outcomes, regulatory authorities have instituted more flexible pathways for manufacturers to bring these important treatments to market while still ensuring safety and efficacy.
 
Join Cardinal Health Specialty Solutions on Tuesday, February 9th at 11:00 AM EST as clinical, regulatory and real-world evidence experts discuss the impact of decentralized trials on the evolution of drug development in oncology. Topics include:
 
  • Acceleration of bench-to-bedside timelines in oncology
  • Emergence of decentralized trials
  • Impact of decentralized trials on regulatory pathways
  • Real-world evidence’s influence on future trial design

Speakers:

  • Bruce A. Feinberg, DO- VP of Clinical Affairs and Chief Medical Officer, Cardinal Health Specialty Solutions
  • Todd Phillips, PharmD– Director of Regulatory Affairs, Cardinal Health Regulatory Sciences
  • Scott Swain, PhD, MPH– Director of Real-World Evidence and Regulatory, Cardinal Health Specialty Solutions
Register Now!



[VIRTUAL LAUNCH] Redefining Virus Manufacturing with NevoLine™ Upstream

[VIRTUAL LAUNCH] Redefining Virus Manufacturing with NevoLine™ Upstream

01.13.21

NOW AVAILABLE ON DEMAND

Univercells Technologies has been working to leverage deep expertise in bioprocessing and equipment development to revolutionize virus manufacturing for gene therapy and vaccine production. By combining the principles of intensification and chaining, the company has introduced the NevoLine™ Upstream platform, a fully automated and integrated biomanufacturing unit designed to enable commercial scale capacity in a compact module. 

 

Directly from its development site in Belgium, Univercells Technologies is inviting you to join the virtual product launch of this breakthrough technology. The event will highlight the features of the NevoLine Upstream platform, including an explanation of the main benefits and key performance data. Attendees will see how users of the NevoLine Upstream platform can increase viral productivity while benefiting from a flexible process approach in a reduced footprint.

 

The event will offer: 
 

  • A review of the principles of intensification and chaining and how they directly influence viral performance, manufacturing footprint, and overall costs
  • A demonstration of how the NevoLine Upstream platform enables commercial upstream and midstream GMP manufacturing in a 3m2 (~32 ft2) footprint
  • A look at how the design of the NevoLine Upstream platform aligns flexibility and productivity to accommodate various process configurations
  • A comparison of footprint, Capital Expenditure, and Cost of Goods gains using the NevoLine Upstream platform versus conventional technologies
Register Now!


Single Use Containment Technology: Multi-site Logistics of Toxic & Sterile Powders

Single Use Containment Technology: Multi-site Logistics of Toxic & Sterile Powders

11.19.20

NOW AVAILABLE ON-DEMAND

Learning Objectives

  • Discover a new implementation of packaging for the safe transport of high potency and/or sterile ingredients between DS production and DP formulation facilities. 
  • Learn how disposable containment technology can change the status quo and provide additional benefits to both CMO’s and end-users / product owners alike.
  • Gain insight in to how these technologies have been validated to meet the needs of primary packaging, sterility assurance and powder containment.

 

Who is it for:

  • Pharmaceutical companies with CMO partners looking to deploy faster off the shelf solutions that can be utilised throughout their in-house and extended networks.
  • CMO’s and ingredients manufacturers looking for standardised packaging formats that add value and to their products and improve their customers convenience from goods receipt to processing methodologies.
  • Supply chain partners responsible for managing CMO partnership and the associated value chain for receiving product.
  • Packaging Engineers looking to discover and implement new packaging formats that can benefit their companies’ operations.
  • Process and production Engineers who need to solve powder containment challenges during transfer to and handling within the production facility.
  • Quality and Validation Engineers looking to solve sterility assurance challenges associated with packaging of product for storage and transportation and the transfer of powders for aseptic filling.

 

Speaker:
 

Ben Wylie

Senior Product Manager, ChargePoint Technology


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The Future of Pharmaceutical Manufacturing: Multi-Product Facility and Equipment Design

The Future of Pharmaceutical Manufacturing: Multi-Product Facility and Equipment Design

11.12.20

NOW AVAILABLE ON-DEMAND

In an ever-advancing regulatory environment, it is imperative for CDMOs to invest in facility design, equipment, and technology solutions that safely and effectively support multiple products from a range of clients. During this webinar, pharmaceutical developers will gain an understanding on:

  • Approaches that may eliminate the need for dedicated production equipment and facilities, thus maintaining the benefits of outsourcing and efficiencies of scale.
  • Advances in equipment and technology that will strengthen safety methods, while maintaining flexibility for multi-product plants.
  • How the decisions CDMOs make today transform the way products in multi-product facilities will function together in the future.
 
Presenters:


  • Steve Nole - Vice President, Operations, Grand River Aseptic Manufacturing
  • Les Edwards, MSE - Vice President of Technology and Business Development, SKAN
  • Andre Zdunczyk - Regional Business Development Director, USA, Bausch + Strobel
Register Now!



Planning and Executing a Media Fill: A Guide to Aseptic Process Validation for Lyophilized Products

Planning and Executing a Media Fill: A Guide to Aseptic Process Validation for Lyophilized Products

11.04.20

NOW AVAILABLE ON-DEMAND

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


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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

NOW AVAILABLE ON-DEMAND

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

NOW AVAILABLE ON-DEMAND

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


Register Now!


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

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


Register Now!


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

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


Register Now!


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

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

07.29.20

NOW AVAILABLE ON-DEMAND

Register Now!

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

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:


  • 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


Register Now!


Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces

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:
 
  • 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


Register Now!


Biopharmaceutical Process Characterization

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


Register Now!


Pharma Packaging Considerations for Radiation Processing

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 


Register Now!


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