Biophorum webinars

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. Presented by Andrew Brewer, Roche Genentech and Roisin Magee, Pfizer

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. Presented by Bruce Kane, Rockwell Automation and Kelsey Hill, Emerson and broadcast on 4 June 2020.

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.
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