Presented by industry experts, BPSA’s Webinar Series is developed to address technical and business topics of interest to our membership and the industry.
Use the webinar archive below to access materials from previous sessions. If you would like to sponsor a webinar, please contact us.
2023 Webinar Series
From Theory to Practice: the Design, Control & Monitoring of Single-Use Systems (SUS) for Integrity Assurance
Originally Presented on October 31, 2023
In this webinar, learn about:
- The new BPSA Technical Guide on SUS Integrity Assurance, Volume 2
- Current standards and regulations impacting integrity assurance in SUS
- Case studies, technologies and tools that can be used to build an integrity control strategy
Presenters: Patrick Evrard, Cytiva, BPSA Integrity Assurance Committee Chair; Monica Cardona, Millipore Sigma; Charlotte Masy, GSK; Nathalie Pathier, Sartorius; Scott Patterson, ILC Dover; Changhong Zhang, Sanofi
Additional Resources: BPSA Technical Guide on SUS Integrity Assurance, Volume 2
Pivotal Challenges to Viral Vector Manufacturing and the Role of Single-Use
Originally Presented on May 4, 2023
In this webinar, learn about:
- The role of single-use technologies (SUT) in viral vector manufacturing.
- Key factors on how SUT enables viral vector manufacturing and scale up.
- Are there any FDA or other regulatory guidance that SUT users can use to assess E&L testing?
- Is automation a factor in viral vector manufacturing?
- What key challenges remain to overcome to continue to bring new products to market?
Presenters: Francesca Bellintani, AGC Bio; Jason Dowd, CCRM, Mike Gillmeister, RegenX Bio
Additional Resources: Single-Use Technologies Enable Manufacturers to Meet Pivotal Challenges of Viral Vector Manufacturing
Implementation of X-Ray Sterilization of Single-Use Systems: What to Expect
Originally Presented on March 9, 2023
In this webinar, learn about:
- The 2nd BPSA white paper: Cross-Industry X-Ray Qualification Data Demonstrating Equivalent Behavior with Gamma Data
- What materials & components have been evaluated and perform well, and if there are any single-use materials that are poor candidates for X-ray
- The different approaches to demonstrate the equivalency after gamma and X-ray
- Timelines, industry irradiation capacity, implementation ramp up and key risks
- Regulatory perspectives
- Staying current with new X-ray publications and industry groups
- Other activities (risk assessment) in other industry groups, especially on the high risk items
Presenters: Samuel Dorey, Sartorius; James Hathcock, Pall Corporation
Advancing Facility Flexibility Through Single-Use Automation
Originally Presented on February 23, 2023
In this webinar, learn about:
- The benefits of single-use production equipment and aligned digital automation strategy from the perspective of an end-user of single-use products;
- How to achieve suitable single-use automation through simplicity, flexibility and agility; and
- Strategies to align business processes with technology and staff behaviors to seamlessly operate a facility with single-use and automation.
Moderator: Stuart Tindal, Sartorius
Presenter: Matt Kessler, MSD Switzerland
Automation Challenges in the Design and Execution of a Single-Use Facility
Originally Presented on February 16, 2023
In this webinar, learn about:
- Challenges to anticipate during equipment selection and how to overcome them;
- Data integrity, compliant ways to collect data from OEM Vendor equipment and the pitfalls;
- Examples of automation challenges in single-use plant design and solutions;
- How the design of equipment communication can impact your change management strategy;
- How upfront equipment specifications can avoid future issues even for “off-the-shelf equipment;” and
- When to:
- Remove a vendors control system
- Integrate it into the process control system
- Not fix something that is not broken.
Moderator: Stuart Tindal, Sartorius
Presenter: Jeff Leverton, Wood
2022 Webinar Series
An Introduction to PFAS and Fluoropolymers and Their Use in Single-Use Bioprocessing
Originally Presented on November 8, 2022
In this webinar, learn:
- Where PFAS chemicals come from
- How they may be used in single-use biomanufacturing
- What the consumer and regulatory implications may be for BPSA members and the single-use biomanufacturing industry
Speakers: Frank Adamsky, Daikin America; Barbara Henry, W.L. Gore & Associates; Steve Risotto, American Chemistry Council; Bob Sassa, W.L. Gore & Associates
Exit/Succession Strategies: The Case for Employee Ownership (ESOPs)
Originally Presented on March 17, 2022
ESOPs (Employee Stock Ownership Plans) can help you establish a transition plan for your business and provide for an ownership culture within your company, along with other benefits. Learn from a company which has been an ESOP for 15+ years:
- How ESOPs work
- ESOP’s structure
- ESOP benefits including a 100% federal tax-free status
Speaker: Ken Baker, CEO, NewAge Industries/AdvantaPure
Plastic Packaging and Bio-Process Systems Consolidation: Using M&A to Survive and Thrive
Originally Presented on March 16, 2022
In this webinar, learn valuable strategies designed to help company owners understand how to navigate and succeed in today’s mergers and acquisitions environment.
Attendees will learn:
- Globalization Consolidation Trends
- Special Issues in Bio-Process and Pharma
- How to Best Sell Your Business
Speaker: Thomas Blaige, CEO & Chairman, Blaige & Company
2021 Webinar Series
2021 BPSA Annual Membership Meeting
Originally Presented on October 5, 2021
BPSA’s 2021 Annual Membership Meeting was held virtually and provided attendees with an overview of technical achievements, financials, and general updates for the association. Guest speaker and BARDA director, Gary Disbrow, presented an update on BARDA’s Vaccine Capacity Expansion Efforts.
*Important note: The above slides are a curated selection of the annual meeting presentation. Members can reach out to Leslie Pizarro for the full slide deck and a link to the recording of the meeting.
Financing Global Health Resilience
Originally Presented on July 16, 2021
As countries in the developing world face the immense challenges of the COVID-19 pandemic, addressing both communicable and the increasing prevalence of non-communicable diseases (NCDs) creates new strains on emerging market health systems. DFC has financing tools that the private sector can use to mitigate the risk of investing in emerging market health systems. During the webinar, experts from DFC will discuss:
- DFC priorities in the health sector
- DFC tools available and potential ways to partner with BPSA members
- Eligibility requirements and how to get started with DFC
Speaker: Nafisa Jiwani (U.S. International Development Finance Corporation)
Sustainable Recyclable Flexible Systems: Improving the Environmental Footprint
Originally Presented on July 15, 2021
Single-use Technologies (SUT) in cell-based and vaccine manufacturing is growing as it provides increases in manufacturing economy, speed safety, and flexibility. Life Cycle Assessment (LCA) has demonstrated that SUT usually produce less environmental burden than does the conventional, durable manufacturing.
This presentation explores how SUT supports the UN Sustainability Development Goals, how plastic circularity could be applied to our own industry and steps taken by BPSA to ensure that solution sets are made available to our members.
Speakers: William Whitford (DPS Group); Sade Mokuolu (Watson-Marlow Fluid Technology Group)
Global COVID-19 Vaccine Supply Chain Landscape
Originally Presented on June 16, 2021
10 to 14 billion doses of COVID-19 vaccine are needed to inoculate the world and ensure global immunity. It is imperative that we continue to mobilize global resources to meet this goal.This presentation explores supply chain inputs, including manufacturing, through procurement, export, delivery and use of materials for COVID-19 vaccine manufacture.
Speaker: Matthew Downham (Coalition for Epidemic Preparedness Innovations (CEPI))
Discussion of the BPSA White Paper on X-Ray Sterilization of Single-Use BioProcess Equipment, Part 1
Originally Presented on May 17, 2021
This presentation explores:
- Why patients, biomanufacturers and suppliers win by qualifying X-ray in addition to gamma.
- The technical and regulatory considerations for X-ray qualification
- The rationale behind the BPSA industry consensus risk assessment and testing approach
Speakers: Samuel Dorey (Sartorius Stedim Biotech); James Hathcock (Pall Corporation); Charlotte Masy (GSK Vaccines)
Additional Resources:
Download the White Paper
Transit Testing Guidance for Single-Use Components & Assemblies
Originally Presented on April 14, 2021
This presentation explores:
- Why a risk-based approach to transit testing qualification should be applied for materials transported among manufacturing facilities of biotech production.
- Why suppliers and end-users should collaborate to ensure packaging properly protects materials in transit.
- How standardized laboratory simulations from ASTM, ISTA, and ISO, along with field testing, are reviewed and contrasted, with consideration of single-use products.
Speakers: Rich Salzstein (Smithers); Elisabeth Vachette (Sartorius Stadium Biotech); James Raw (Smithers)
Additional Resources:
Download the White Paper
Sustainability Throughout the Value Chain: Insights from the Food Industry
Originally Presented on March 24, 2021
This presentation explores the challenges associated with recycling infrastructure, as well as:
- The Impact of Resources Waste on the Environment
- Case Studies on Transition from Metal to Plastic
- The Challenges Within the Recycling Infrastructure for Multilayer Flexibles
Speaker: Tiffani Burt, PhD (Sealed Air Corporation)
Economic Recovery and Plastics Industry Prospects
Originally Presented on March 11, 2021
The 2020 pandemic disrupted a thriving U.S. economy and a growing plastics industry. While economic recovery is expected to continue this year and the next, residual effects of the pandemic will influence business activities and consumer behavior. This presentation reviews questions such as:
- Is the plastics industry poised for growth in 2021?
- What can the plastics industry and its end-markets expect this year as adjustments from the pandemic disruptions continue?
Speaker: Perc Pineda, PhD (Plastics Industry Association)
2020 Webinar Series
Guide to Single-Use Training, Part 3: Current Trends and the Top Ten Things to Consider to Manufacture and Use Single-Use Technologies
Originally Presented on November 19, 2020
This presentation reviews the current trends in single-use technologies, the road to standardization, advantages of SUT, and more.
Speakers: James Dean Vogel (The BioProcess Institute)
Preview of Webinar Deck
*Important note: BPSA is not able to share the full powerpoint that was presented during the live webinar. If you are interested in learning more about the training series, please reach out to The BioProcess Institute.
Guide to Single-Use Training, Part 2: Single-Use Technologies’ Implementation and Regulatory Perspectives
Originally Presented on November 12, 2020
This presentation provides an overview of single-use technologies, their Implementation Strategies, and regulatory perspectives.
Speakers: James Dean Vogel (The BioProcess Institute)
Preview of Webinar Deck
*Important note: BPSA is not able to share the full powerpoint that was presented during the live webinar. If you are interested in learning more about the training series, please reach out to The BioProcess Institute.
Guide to Single-Use Training Series, Part 1: BioPharmaceutical Manufacturing and Single-Use Technologies
Originally Presented on November 5, 2020
This presentation provides an overview of the bio-pharmaceutical industry, how & why single-use technology is deployed in support of the industry, and how single-use is specifically utilized to enable safe and effective vaccine and biologic therapies.
Speakers: James Dean Vogel (The BioProcess Institute)
Preview of Webinar Deck
*Important note: BPSA is not able to share the full powerpoint that was presented during the live webinar. If you are interested in learning more about the training series, please reach out to The BioProcess Institute.
Building an Integrity Assurance Approach in Single-Use Processing through the SUS Whole Life Cycle
Originally Presented on October 21, 2020
This presentation provides an overview of why integrity of single-use systems matters, the current regulatory landscape, best practices developed by suppliers and end-users, and a case study review of a successful end-user implementation of an integrity test method.
Speakers: Marc Hogreve (Sartorius Stedim Biotech); Charlotte Masy (GSK Vaccines); Hélène Pora (Pall Corporation)
BPSA Annual Membership Meeting
Originally Presented on October 6, 2020
BPSA’s 2020 Annual Membership Meeting was held virtually and provided attendees with an overview of technical achievements, financials, and general updates for the association. Guest speaker and BARDA consultant, Tom Warf, presented an update on Operation Warp Speed.
*Important note: The above slides are a curated selection of the annual meeting presentation. Members can reach out to the BPSA team for the full slide deck.
Overview of BPSA’s Technical Guide, Extractables/Leachables Considerations for Cell & Gene Therapy Drug Product Development
Originally Presented on September 23, 2020
This presentation provides an overview of Extractables and Leachables and their role in cell and gene therapy,
the regulatory environment surrounding these issues, and strategies to stay ahead of this complex set of risks.
Speakers: Armin Hauk (Sartorius Stedim Biotech); Brendan Lucey (Gemini BioProducts); Joseph St. Laurent (Chemic Laboratories)
Additional Resources:
X-Ray Sterilization Requirements for Single-Use Bioprocess Equipment. It’s Coming Sooner Than You Think!
Originally Presented on September 2, 2020
To help better understand and assess the technical risks associated with x-ray irradiation of single-use technologies, well-established industry experts share their technical understanding of the impact of x-ray on plastics as compared to gamma-irradiation, as well as their extensive experience working with regulators and the medical device industry to implement x-ray.
Speakers: Thomas Kroc (Fermilab); John Logar (Johnson & Johnson)
Additional Resources:
Download AAMI publication: Industrial Sterilization: Process Optimization and Modality Changes
Single-Use Bioprocessing Growth and Adaptations: Lessons from Space
Originally Presented on July 17, 2020
Scott Patterson, Vice President, Pharma/BioPharma, Technical Support of ILC Dover demonstrates how the same lessons learned when designing the spacesuit for first walk on the moon can be applied to the new challenges facing the biopharmaceutical manufacturing industry in times of critical need, such as the current race for vaccine production to curb the COVID-19 pandemic spread.
Trends in Bioprocessing that Affect Single-Use Technologies and Adoption
Originally Presented on July 16, 2020
Eric Langer, Co-founder and Managing Partner of BioPlan Associates, presents a summary of the impact of COVID-19 on single-use trends and the acceleration of adoption of key SUT technologies, and other critical trends affecting regionalization/globalization associated with bioprocessing, precipitated by the current COVID-19 crisis.
Additional Resources from BioPlan Associates:
Download Top 15 Biomanufacturing Trends White Paper, 2020 (Complimentary)
Plastics Recycling in the ’20s: Back to Atoms
Originally Presented on June 25, 2020
This presentation reviews the history of plastics recycling and the technology that supported it, the enormity of the waste question today, and the necessity for more robust and universal processes for dealing with waste materials.
Speaker: Dr. William Carroll, Carroll Applied Science, LLC
Additional Resources:
Download Q&A
BPSA’s New 2020 Particulates Publication: Guidance for Single-Use Equipment Providers and Users
Originally Presented on May 27, 2020
In this webinar, authors of the recently released BPSA Particulates Guide will speak about why the challenge of particulate control is becoming even more important as single-use systems find increased market adoption.
Additional Resources:
Download Q&A
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