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