BioPhorum IT: Lab of the Future – Manifesto: digital technology-based capabilities for the quality control lab of the futurePresented by: Graeme Carter, QC Lab of the Future Lead, Pfizer Most QC laboratories in biomanufacturing have not yet achieved digital transformation. This manifesto articulates a necessary, realistic, and achievable vision of the QC lab of the future shared by leading biomanufacturers.
Electronic product information in the pharmaceutical industry
Presented by: Stephen Hammond, Senior Manager Artwork and Labelling, Pfizer
Electronic product information in the pharmaceutical industry: Implementation and solutions overview from a packaging perspective
Originally presented to the JBA as part of a series of webinars, this video will take the viewer through the implementation of ePI in the biopharmaceutical industry and the benefits from a packaging perspective.
Cell and gene therapy process maps – a first step towards industry standardization
Presented by: Jørgen Magnus, Head of Bioprocess Technology, Bayer
BioPhorum’s Commercialization Workstream has generated a series of cell and gene therapy process maps containing example processes, unit operations and platform technologies being used in manufacturing. The maps form a common frame of reference for scientists and engineers working within the field. They also encourage collaboration on process improvements that will benefit future cell therapy patients by supporting the acceleration of commercialization of novel modalities.
BioPhorum introduces – The importance of a strategic approach for the development of the biopharmaceutical manufacturing industry
9th January, 2022
Bob Brooks, BioPhorum Supply Partner Lead and Clare Simpson, BioPhorum Technology Roadmapping Lead share their thoughts on the recent focus on a new strategy. Answering questions about why BioPhorum published the new technology vision and how this instructed a need for a strategic framework.
BioPhorum introduces – EU MDR
BioPhorum introduces – the Speed to Clinic initiativeSpurred on by lessons learned from the COVID-19 pandemic, combined with the ever-pressing need to streamline development and get medicines to clinics faster, BioPhorum has launched a Speed to Clinic initiative. As a priority topic for the industry, this has been met with much enthusiasm. We hear from Richard Alldread, Senior Director, Recombinant Product Development at CSL Behring Innovation GmbH, and Kartik Subramanian, Vice President, Science & Technology Biologics and Nick Abu-Absi, Director, Cell Culture Development both at AbbVie. They share their thoughts about the importance of this initiative, and outline how the industry is working together to solve the challenges of bringing medicines to clinic more quickly and effectively.
How to implement the human readability study of single characters – application for biopharmaceutical vision system settingsPresented by: Steen Christiansen, Principal Scientist – Packaging, Novo Nordisk It is the authority’s expectation that any print is correct and readable for the patient. Therefore pharmaceutical companies must be able to document traceability between what patients can read and understand, and how much of a single character can be missing before correct interpretation is impaired. Since the early 1990s, it has been common practice in pharmaceutical packaging that whenever batch-specific data is printed during the packaging process, the data is checked using vision systems. The BioPhorum Secondary Packaging workstream has prepared a study and report for human readability of single characters to provide supporting data to establish limit characters, i.e. what degree of print defect for a single character results in the character not being recognized properly by the human reader. This will serve as the basis for specific vision system settings which should reduce labeling errors. Steen presents an overview of the study followed by a discussion on how to implement and take value from the results.
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 points17 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.
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.
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.
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.
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
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
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
BioPhorum Technology Roadmapping: Inline monitoring and real time release
BioPhorum Technology Roadmapping: Modular and mobile
Presented by: Maik Jornitz, CEO, G-Con An overview of the roadmap program