Experts from Cytiva discuss the filtration challenges of diversifying molecule pipelines. We explore how the industry is evolving to achieve increases in efficiency through process intensification and take a look at how changing regulation and sustainability targets are impacting technology.
Bioprocess scientists, mAb process developers, Regulatory, Quality assurance
Jon Petrone
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Senior Director, Global Technical Consultancy, Cytiva
Jon has 20 years’ experience supporting customer manufacturing processes at Cytiva. In his current role, he oversees teams supporting process development and MSAT in downstream purification of proteins and gene therapy products. Jon previously worked as a principal engineer at Wyeth Biotech, where his team provided instrumental technical support for drug development and commercialization.
Morven McAlister, PhD
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Senior Director, Regulatory and Validation, Cytiva
Morven McAlister has deep technical expertise in microbial contamination control and extensive experience in test design, regulatory strategy, and process-specific filter validation. She is active in industry task forces developing global standards for contamination control. She joined Pall Life Sciences (now Cytiva) in 2001 and has a PhD in microbiology from the Queen’s University Belfast.
Mike Collins
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Senior Director, Bioprocess Filtration R&D, Cytiva
Mike Collins began his journey in filtration over 30 years ago, building technical expertise in various industries before moving into biotechnology in 2008. At Cytiva, Mike leads a global team developing filtration solutions for antibody-based therapies, viral vectors, and mRNA. He also plays a key role supporting customers in filtration activity across the bioprocessing workflow.
James Hathcock
[email protected]
Principal Director, Regulatory and Validation Strategy, Cytiva
James joined Pall Medical (now Cytiva) in 2008, and now leads strategy to help manufacturers implement technologies safely and successfully. He is active in BioPhorum, BPSA, ASTM, ASME-BPE, PDA, and ISO, and in initiatives focused on single-use security of supply and safety. He previously directed the protein purification lab for drug discovery and characterization at Mt. Sinai School of Medicine in New York City.