BioProcess Consulting

Bioprocess Consultant — 25 Years of Expertise

Cawsam BioProcess Consulting is an independent consultancy led by Martin Smith, providing expert bioprocess support from bench to 20,000L commercial scale. GMP manufacturing, tech transfer, process development and facility design across monoclonal antibodies, viral vectors, recombinant proteins, cell therapy and cultivated meat.

Including tech transfer lead on AZD1222 — Oxford-AstraZeneca COVID-19 vaccine

Martin Smith — bioprocess consultant with 25 years experience in GMP manufacturing, tech transfer and facility design
25+ Years
Experience
PhD Biochemical
Engineering, UCL
Lonza | Merck
| AstraZeneca
Bench to
20,000L Scale
GMP Certified
Operations

Areas of Expertise

End-to-end bioprocess support across the full development and manufacturing lifecycle

Process Development

Upstream and downstream process development for mAbs, recombinant proteins, viral vectors (AAV, lentiviral), vaccines and cell therapies. Bench to pilot scale optimisation using DoE methodologies.

Tech Transfer & Scale-Up

GMP tech transfer from development to manufacturing scale. Proven track record from bench to 20,000L bioreactor scale. Regulatory package preparation for IND/BLA submissions.

Facility Design & Start-Up

Design and specification of GMP bioprocessing facilities from concept to operational handover. Equipment selection, cleanroom design, environmental monitoring systems, buffer and media preparation at scale.

CMO Selection & Management

Request for proposal preparation, CMO/CDMO evaluation and selection. Ongoing technical oversight of outsourced manufacturing programmes.

Regulatory & GMP Compliance

GMP operations, quality systems and regulatory strategy. Experience supporting EMA Emergency Use Authorisation and IND/BLA submissions across multiple modalities.

Operational Excellence

Lean Six Sigma Black Belt. Process optimisation, capacity modelling, cost of goods analysis. Delivered 41% business growth at Lonza and 50% DSP capacity increase without process changes.

Modalities

Broad experience across biological modalities

Monoclonal Antibodies (mAbs) Viral Vectors (AAV, Lentiviral) Recombinant Proteins Vaccines (VLP, Plasmid DNA) Cell Therapy Cultivated Meat Antibody Drug Conjugates Gene Therapy

Career History

A track record built across the industry's leading organisations

Cawsam BioProcess Consulting Ltd
Managing Director & Lead Consultant
Apr 2022 – Present
  • Independent consultancy providing bioprocess expertise across mAbs, viral vectors, recombinant proteins, cultivated meat and more
  • Supporting clients from early development through to commercial manufacturing
The Vaccines Manufacturing and Innovation Centre (VMIC)
Head of Manufacturing Science, Technology & Process Development
Aug 2020 – Apr 2022
  • Established 7,000m² innovation and pandemic response facility for vaccines — bench to 2,000L bioreactor scale
  • Seconded to AstraZeneca as Tech Transfer Lead for AZD1222 (Oxford COVID-19 vaccine) supporting EMA Emergency Use Authorisation
  • Designed Process & Analytical development laboratories and GMP manufacturing processes
Menarini Biotech
Head of Menarini Biotech UK Branch
May 2018 – Aug 2020
  • Built UK satellite facility from scratch — £0.8m capex, 400m², 5 FTEs
  • Led tech transfer of two antibody drug substance projects
  • Managed CMO selection and outsourcing of lead candidate
Exmoor Pharma Concepts
Head of BioProcess & Technology Development
Jul 2015 – May 2018
  • Led start-up of Cell & Gene Therapy laboratory
  • AAV purification process development and optimisation
  • Supported Cprep™ — novel automated cell therapy cryopreservation system with NHS Blood and Transplant
Lonza
Head of Mammalian Process Development
Mar 2013 – Jun 2015
  • Led mammalian process development across Slough, Cambridge and Singapore — 8 direct, 150 indirect reports
  • 41% business growth during 2-year tenure
  • Keynote presenter at 3 international conferences (EU, US)
Lonza
Head of Purification Development & Earlier Roles
Apr 2003 – Mar 2013
  • Standardised DSP platform delivering major efficiency gains
  • Continuous Improvement Lead — 50% DSP capacity increase without process changes
  • Lean Six Sigma Black Belt certification
  • Led Lonza's first 4x20,000L facility start-up programme
  • Cost of goods modelling across global operations
Merck
Senior Research Biochemical Engineer
Sep 1997 – Sep 2000
  • Process development for Gardasil (HPV vaccine) and HIV vaccine plasmid DNA
  • 10,000-fold scale-up of ultrafiltration step to manufacturing scale
  • GMP clinical campaigns Phase I through Phase III
Martin Smith, PhD — founder of Cawsam BioProcess Consulting, former Tech Transfer Lead for Oxford-AstraZeneca COVID-19 vaccine

About Martin Smith

With over 25 years of experience spanning process development, GMP manufacturing, technology transfer and facility design, Martin Smith brings rare end-to-end expertise to every engagement.

Martin's career has taken him from early-stage academic translation through to large-scale commercial manufacturing at some of the world's leading biopharmaceutical organisations — including Lonza, Merck and AstraZeneca.

As Tech Transfer Lead for the Oxford-AstraZeneca COVID-19 vaccine (AZD1222), Martin supported the batch production and regulatory package that led to the EMA Emergency Use Authorisation — one of the most consequential bioprocess programmes of the last decade.

Cawsam BioProcess Consulting was founded in 2022 to bring this depth of experience directly to clients who need it most — whether that's a startup navigating their first GMP campaign, a pharma company evaluating CMO partners, or a research group translating a promising therapy toward clinical use.

Education & Credentials

  • PhD Biochemical Engineering — UCL (1993–1997)
  • BEng (Hons) Biochemical Engineering, 1st Class — UCL (1990–1993)
  • Lean Six Sigma Black Belt

Frequently Asked Questions

What services does Cawsam BioProcess Consulting offer?

Cawsam Bio provides expert consultancy in bioprocess development, GMP manufacturing, technology transfer and scale-up, facility design and start-up, CMO/CDMO selection and management, and regulatory and GMP compliance. We work across monoclonal antibodies, viral vectors, vaccines, cell therapy and cultivated meat.

Who is Martin Smith?

Martin Smith is the founder and lead consultant at Cawsam BioProcess Consulting. He holds a PhD in Biochemical Engineering from University College London (UCL) and has over 25 years of industry experience at Lonza, Merck and AstraZeneca. Martin served as Tech Transfer Lead for the Oxford-AstraZeneca COVID-19 vaccine (AZD1222), supporting the EMA Emergency Use Authorisation.

What biological modalities does Cawsam Bio work with?

Cawsam Bio has experience across monoclonal antibodies (mAbs), viral vectors (AAV, lentiviral), recombinant proteins, vaccines (VLP, plasmid DNA), cell therapy, cultivated meat, antibody drug conjugates and gene therapy.

How do I engage Cawsam BioProcess Consulting?

Contact Martin Smith directly at martin@cawsambio.com or use the contact form below to describe your project. Cawsam Bio works with startups, pharma companies, research groups and CDMOs worldwide.

What scale of bioprocessing does Cawsam Bio support?

Cawsam Bio supports projects from bench scale through to 20,000L commercial bioreactor scale, covering the full lifecycle from early process development through GMP manufacturing and regulatory submission.

Discuss Your Project

Whether you're at the earliest stages of process development or need experienced oversight of a complex manufacturing programme — get in touch to discuss how Cawsam Bio can help.