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.
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