BioPhorum webinars

BioPhorum is here to help you and your operations to make better decisions, faster. Our webinar program is designed to support the outputs from our members and to drive the adoption of best practices.

With productivity accelerating and the volume of publications doubling year on year, BioPhorum has launched a webinar program to support this work. With both public and member-only webinars, BioPhorum aims to provide you with the information you need to take back to your company in order to accelerate its rate of progress for the benefit of all.

BioPhorum extractables data review for end users.

Presented by: Carsten Worsøe, Principal Scientist, Novo Nordisk

Carsten presents the process, purpose, focus points, and results of the BioPhorum extractable data review for end users. In answer to the problem statement: are all solvents and timepoints of value in the proposed BioPhorum protocol from 2014?  

The new protocol includes significant changes to the 2014 version, including the removal of 5M sodium chloride and 1% Polysorbate 80 as extraction solvents, the elimination of the time-point zero interval, and the elimination of elemental analysis of 50% Ethanol extracts. 

 

In-bound supply chain strategic framework

If we are to adjust to the new normal as we move from ‘Covid-19 pandemic to endemic’, industry must take ownership of the in-bound supply chain. It needs an overarching strategy to guide plans for solving the most critical issues and strengthen and advance in-bound supply chain operations. 

BioPhorum’s Supply Partner leadership team decided it needed to ‘own’ this action and has launched its Strategic Framework for the Development of the Biopharmaceutical Manufacturing Industry In-Bound Supply Chain. The Framework is patient-centric, responds to regulatory affairs, and will allow the industry to focus on solving the industry’s most important challenges. 

In this webinar, Guido Kremer, Senior Consultant, Global BioPharm Center of Excellence at Merck, and Benjamin Jequier, Head of Site Supply Chain at Takeda discuss the importance of creating this framework and the value that it will bring.

A standardized risk assessment tool enabling a harmonized approach for selection & definition of environmental monitoring points

17 September 2021

Presented by :

Frederic Ayers, Research Scientist, Eli Lilly

Manshi Patel, Associate Director – Microbial Control and Sterile Support, MSD

Dawn Watson, Director, Sterile & Validation Center of Excellence, MSD

Our three subject matter experts from BioPhorum’s Environmental Monitoring workstream present a clearly defined risk-based assessment tool for selecting and defining Environmental Monitoring (EM) sampling locations in a routine monitoring program. Hear directly from members of the BioPhorum EM team, a collaboration of over 20 global pharma companies who worked to create the tool. The session also takes you through a comprehensive Q&A section that expands on and provides a broader context to the original presentation.

BioPhorum introduces – the plug-and-play concept

19th July, 2021

In this podcast, we talk to Kelsey Hill, Life Sciences Marketing Manager, Emerson, Jean-Luc Gerling, Solution Manager, Merck, and Gene Tung, Executive Director, MSD about the concept of plug-and-play, its testing and adoption in the biopharmaceutical industry, and how the current global pandemic has changed the approach.​

 

 

 

BioPhorum introduces – addressing the gap in industry alignment and regulatory practice

14th July, 2021

Small-scale models and their qualification are important steps of biopharmaceutical process development, characterization, and validation. Despite being required by regulatory bodies, there is no guidance on current best practices and companies use many different qualification approaches throughout the industry.

In this podcast, we hear from some of the lead authors from BioPhorum’s Small Scale Models Workstream who contributed to the article Justifications of small scale models: an industry perspective to hear their thoughts on how it addresses the gap in industry alignment and regulatory practice. Prasad Pathange, Director at Bayer, Kiran Andra, Development Scientist at Alexion Pharmaceuticals, Robert Luo, Scientific Director and Downstream Process Development at GlaxoSmithKline, and Joschka Buyel, Process and Knowledge Management Scientist at Bayer discuss what they think about the current situation and their thoughts for the future.

 

 

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BioPhorum Podcast

Addressing the gap in industry alignment and regulatory practice

An industry perspective on common practice in forced degradation studies of biopharmaceuticals

15 June, 2021

Presented by : Surinder Singh, Senior Scientist, BMS, Niclas Chiang Tan, Director, Takeda, Göran Hübner, Head of Laboratory, Boehringer Ingelheim, Christoph Grapentin, Principal Scientist, Lonza Drug Product Services, John Campbell, Scientific Leader and GSK Fellow, GlaxoSmithKline R&D, Liqiang Lisa Zhou, Principal Research Scientist, AbbVie, Elaine S.E Stokes, Account manager and Facilitator, BioPhorum.

Forced degradation studies (FDS) are a crucial part of the drug lifecycle process because companies need to fully understand their molecule, including how it reacts to different stress conditions.

However, there is a lack of clear regulatory guidance on how, when, and why to undertake FDS—only that they should be performed to understand a product further. This means many companies commit a huge amount of time and money to these studies and use trial and error to develop a standardized approach.

To gain an understanding of current industry approaches to FDS, the BioPhorum Forced Degradation Point Share conducted an inter-company collaboration exercise, which included a benchmarking survey and group discussions around forced degradation studies of monoclonal antibodies.

The results of this industry collaboration provide insights into the practicalities of these characterization studies and how they are being used to support the product lifecycle from innovation to marketed products. In this webinar, SME’s will take you through this global benchmarking survey and present these as a guide to a common approach to FDS across the industry which can be used to guide the design of FDS based on CMC product life-cycle and biomolecule needs.

BioPhorum introduces – developing good practices for remote inspections in the Covid era

09th June, 2021

In normal conditions, regulatory inspections and audits are conducted on-site, however, travel and social restrictions due to the Covid-19 pandemic have forced regulatory inspections and audits of affiliates to be conducted remotely.  

This is a very different way of working and a multi-company collaboration, comprising subject matter experts from 29 BioPhorum members, has shared case studies and discussed the practical factors that make remote inspections and audits effective. Learning from post-inspection feedback from inspectors has also been shared. This experience has been captured in Peer to peer practical guidance on remote inspections and audits

In this podcast, a member of the collaboration, Søren Thuesen Pedersen, Senior Director of Quality Intelligence and External Affairs at Novo Nordisk, talks to Dawood Dassu, BioPhorum Fill Finish Lead.

 

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BioPhorum Podcast

Developing good practices for remote inspections in the Covid era

BioPhorum introduces – Pandemic to endemic – a catalyst for supply chain transformation

28th May, 2021

The impact of the Covid-19 pandemic has been far-reaching, not least on the industry’s in-bound supply chain.

In this podcast we talk to Phorum Lead, Bob Brooks and Matthew Neal, Account Manager and Facilitator from BioPhorum Supply Partner who talk about the impact of Covid-19 and how the pandemic is shaping in-bound supply chains for the future.

 

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BioPhorum Podcast

Pandemic to endemic – a catalyst for supply chain transformation

BioPhorum introduces – CGT considerations within product transfer and validation.

5th May, 2021

The process of transferring a product from a developer to a contract development and manufacturing organization and executing a successful validation campaign is a well-established process. However, due to numerous unique aspects required for a cell and gene therapy (CGT) product manufacture, there are a variety of unique or different considerations required during a transfer and validation campaign within CGT. Therefore, although transferring a product is ‘routine’, there is a risk that these CGT considerations are overlooked if treated as a ‘normal’ process.

In this podcast we talk to Senthil Ramaswamy, Director of Cell and Gene Technologies R&D at Lonza; and Iara Cruz, Cell & Gene Therapy Site Manager at Roche, two of the authors from BioPhorum’s Cell & Gene Therapy Validation Workstream who contributed to the article CGT considerations when assigning responsibilities during a product transfer between a sponsor and a contract development manufacturing organization detailing these unique considerations within a CGT product transfer and validation; to gain an insight into the activity leading to the publication and what they see as the benefit of this work.

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BioPhorum Podcast

CGT considerations within product transfer and validation

Standards and best practices to support trace metal quantitation in cell culture chemically defined media and hydrolysates

3 March, 2020

Presented by : Dr Bala Ramanathan, Janssen, Dr Julian Goy, BioPhorum and Dr Diane McCarthy, USP.

Webinar recording of “Standards and best practices to support trace metal quantitation in cell culture chemically defined media and hydrolysates”. Organized by BioPhorum and USP, it was broadcast on 3 March , 2020

Analytical testing at product changeover – a risk based approach

21 May, 2020
Presented by : Andrew Brewer, Roche Genentech and Roisin Magee, Pfizer

The EMA guidance, ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ goes against current best practice for product changeovers (PCO) in the biomanufacturing industry.

The presentation, broadcast on 21 May 2020, demonstrates a response that sets out the currently accepted practices and controls in an evidence-based justification to help companies validate and continue working towards their implementation. The paper at the centre of this webinar promotes: limited or no sampling at PCO, supported by cleaning validation, the use of alternative methods for calculating limits, eliminating the need for a health based exposure limit (HBEL) calculation, the necessary use of additional programs (e.g. eye-sight testing) and the generation of a robust risk assessment that align with industry practices. 

Plug and play bioreactor interface development

4 June, 2020
Presented by : Bruce Kane, Rockwell Automation and Kelsey Hill, Emerson

The BioPhorum Plug and Play team is creating a number of specifications needed to address the problems associated with automating equipment that lacks interoperability in the Biopharmaceutical industry. Typically, equipment skids (Process Equipment Assemblies, or PEAs) need to be treated as bespoke units when they are connected to control systems (Process Orchestration Layers or POLs). This places automation on the critical path for facility design, build and reconfiguration. Here, the example of a Stirred Tank Unit (STU) interface specification is presented. The STU class of equipment includes single use bioreactors, which are central to the manufacturing operations of many companies producing biopharmaceuticals using a batch process at intermediate scales. By combining this specification with NAMUR’s Module Type Package (MTP) approach to interoperability, equipment and control systems providers can reduce the equipment installation time from weeks to days. And by providing good documentation from their quality systems, vendors and suppliers of these systems will enable their customer to benefit from a reduction in validation time. 

Logistics service provider integration

5 December, 2019
The Logistics Service Provider (LSP) Integration paper was published in September 2019. The webinar, broadcast on 5 December 2019, provides an overview of the needs of the biopharmaceutical manufacturing industry regarding the technical integration of biopharmaceutical companies with networks of LSPs. It aims to assist technology companies in the development of products and services, reducing the need for customization and multiple point-to-point solutions. Benefits include enabling the industry to be flexible and cost-effective in its use of multiple LSPs. This specification should also be of interest to vendors considering developing and offering solutions in terms of industry expectations and requirements. Listen now to learn more and hear from the authors of the paper describing the key features and the opportunities for development of industry solutions.

BioPhorum Technology Roadmapping: Inline monitoring and real time release

9 May, 2017
Presented by: Jeff Doyle, Pfizer and Michael Dekner, Shire
The webinar sets out to demonstrate how inline monitoring can accelerate change through the use of the roadmap document.

BioPhorum Technology Roadmapping: Modular and mobile

11 May, 2017

Presented by: Maik Jornitz, CEO, G-Con An overview of the roadmap program

With an overview of the roadmap program, the webinar sets out to demonstrate how modular and mobile can accelerate change.

BioPhorum Technology Roadmapping: Process technologies

16 May, 2017
Presented by: Carl Carlson, M&W Group
With an overview of the roadmap program, this webinar looks at how process technologies can accelerate the change through the use of the roadmap document.

BioPhorum Technology Roadmapping: Knowledge management

18 May, 2017
Presented by: Paige Kane, Merck
Overview of the roadmap program focussing on the knowledge management content.
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