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Alastair Waugh PhD

Analytical, Biopharmaceutical and CMC Specialist.

Alastair has over 15 years’ experience of industrial and regulated biopharmaceutical production from CDMOs, having worked at Lonza Biologics (Slough), SynCoBio Partners (Amsterdam) and 3P Biopharmaceuticals (Pamplona). Prior to industry, Alastair had an academic career focussed on protein biochemistry and working within cancer biology and antibiotic biosynthesis fields

Alastair has found himself as a guardian of product quality, working at the interface between bioproduction and analytics. At 3P Biopharmaceuticals he established and fostered a large Analytical Development group, who together with leaders in Process Development and others, worked on a broad variety of microbial and mammalian protein biologics, from pre-clinical to commercial, encompassing peptides, growth factors, vaccines, pegylated proteins, mAbs, ADCs, VLPs etc. Notably, Alastair was a key player in 3P’s role in developing and manufacturing a pegfilgrastim biosimilar (PELMEG®), the first authorised biosimilar in Spain.

Synergistic to Analytical Development, Alastair has particular interests in ensuring product quality during manufacture and has extensive experience in regulatory expectations for product quality and specifications; and too has co-led process characterisation projects to adjust and establish robust manufacturing processes.

Lastly, Alastair has a particular interest in residual Host Cell Protein impurities and methodologies to ensure their control, having developed, characterised and validated generic, platform and process specific HCPs ELISAs, and worked with production units to demonstrate and optimise clearances.

Alastair lives with his family in Navarra, northern Spain