Pharmaceutical Technologist - January 2008 - (Page 26)

Newcombe and Watson be product and process specific, and dependent on the complexity of the biologic, the commercial status of equipment and methodologies suitable for introduction into a cGMP process.10 However, continuous real time QA may provide greater product and process understanding for defined products; a high assurance of quality on every batch; and alternative, effective mechanisms to demonstrate validation — a focus on process understanding may facilitate risk-based regulatory decisions and innovation. Bioprocess equipment, such as chromatography systems, typically incorporate in-line process monitoring of pH, absorbance and conductivity. Innovative on- or in-line analytical methodologies to evaluate specific product characteristics (activity, affinity, aggregation, conformation, quantification of minor impurities) are unlikely to be incorporated easily into a cGMP process, unless this is driven in conjunction with equipment suppliers. The regulatory requirements for equipment, software and analytical method validation may also present additional technical challenges, particularly if the new technologies evaluated are at a relatively early stage of commercial development or compliance. not be insignificant nor readily incorporated into a cGMP manufacturing process. PT Development Group at Lonza Biologics plc and is currently the process science manager within the process science group, Protherics UK Ltd. He is responsible for a group and several laboratories involved in the development, scale-up and manufacture of antibody derived biotherapeutics. Tony has authored numerous scientific articles, reviews and technical notes, is a chartered chemist, a member of the Royal Society of Chemistry and guest editor for the Journal of Chromatography B. www.protherics.com References 1. D.C. Hinz, Anal. Bioanal. Chem., 384(5), 1036–1042 (2006). 2. W. Whitford and C. Julien, BioProcess International, 5(9), 40–42 (2007). 3. S. Aldridge, Genetic Engineering & Biotechnology News, 27(16) (2007). www.genengnews.com 4. Guidance for Industry, PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004. www.fda.gov/cder/guidance/6419fnl.pdf 5. Slow Adoption of PAT For Bioprocessing, Genetic Engineering & Biotechnology News, 26(16) (2006). www.genengnews.com 6. ICH Q8 Annex: Annex to NfG on Pharmaceutical Development. (EMEA/CHMP/ICH/518819/2007-out for comment). www.ich.org 7. A.S. Rathore, A. Sharma and D. Chilin, BioPharm International, August 01, (2006). 8. Guidance for industry: Q8 pharmaceutical development (May 2006). www.fda.gov/CDER/guidance/6746fnl.htm 9. G.R. Bandurek, BioPharmInternational, 01 May (2005). 10.G. Dutton, Genetic Engineering & Biotechnology News, 24(4) (2005). Keith Watson holds a PhD in biochemistry from Imperial College, London and completed postdoctoral studies at Imperial College and Ludwig Institute of Cancer Research, London. Keith transferred to Industry with Lonza Biologics (UK) as a senior purification scientist, developing and scaling up monoclonal antibody purification processes before moving to Prometic Biosciences (UK) to advise on all bioprocessing activities and manage the Technical Support Group. Keith is currently an accredited pharmaceutical assessor at the Medical and Healthcare products Regulatory Agency, and is involved in reviewing and assessing the pharmaceutical component of Biological Licensing Applications. He regularly provides companies with scientific advice and is currently the UK representative for several EMEA guideline drafting groups. He has authored several scientific articles, reviews and technical notes and was a guest editor for a recent Special Thematic Issue of Journal of Chromatography B, entitled Polyclonal and Monoclonal Antibody Production, Purification, Process and Product Analytics. www.mhra.gov.uk Anthony R. Newcombe holds a PhD in Concluding remarks The introduction of PATs to assess product quality attributes suggests that the complexity of the product and the impact on the process on quality characteristics should form part of a multivariate process development programme — integrating both product and process characteristics to define optimum performance of a process step. Therefore, PAT may find the greatest application initially during biopharmaceutical development and pilot-scale process characterization. The investment required to develop real-time process monitoring tools (utilizing custom or modified bioprocess equipment with new/integrated analytical technologies) at process scale may biochemistry from the Division of Physical Biochemistry, MRC National Institute for Medical Research, London. He has worked previously within the Purification Key points ● ● ● ● Proposed benefits of PAT are reduced time-to-market and reduced regulatory burden for post-approval changes Effective PAT implementation should be based on a detailed understanding of the biochemical and biophysical properties of the proposed drug product. Significant cost increases and logistical hurdles mean that PAT may be best suited for biopharmaceutical development and pilot-scale process characterization rather than incorporation into commercial scale GMP manufacture. Strategies for product development vary depending on the company and type of product and may incorpo rate an empirical or more systematic approach. 26 JANUARY 2008 PHARMACEUTICAL TECHNOLOGIST http://www.genengnews.com http://www.protherics.com http://www.fda.gov/cder/guidance/6419fnl.pdf http://www.genengnews.com http://www.ich.org http://www.fda.gov/CDER/guidance/6746fnl.htm http://www.mhra.gov.uk

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Pharmaceutical Technologist - January 2008 Contents Editor's Comment News Morpheus Market Watch Lagging Japanese Drug R&D Croatia’s Innovation Integrating PAT with Biopharmaceutical Development and Manufacture Q&A

Pharmaceutical Technologist - January 2008

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