Course overview
The importance of the biotech industry has increased significantly over recent years and biotech companies now dominate the new drug pipeline. The industry is gaining momentum and advancements in biomedical science and increased innovation hold vast potential for the growth of the biotech market.
This intensive course will provide an overview of how biotech products are being developed and manufactured, and discuss the scientific and regulatory environment. The interactive programme will cover the latest advances in regulation, including biosimilars and advanced therapies, and address the role and importance of patents within biotech, including what actually can be patented.
CPD Hours: 18
Course Content
- Day 1
- Introduction to biotechnology
- Introduction to molecular biology
- Molecular biology and production of therapeutic proteins
- Day 2
- Development of production organisms
- Fermentation technology and large-scale production
- Process optimisation and scale-up
- Day 3
- Analysis of biopharmaceuticals
- Formulation design of biopharmaceuticals
- Process economics
- Day 4
- Product recovery and purification
- Patenting biotech inventions
- Patent workshop
- Day 5
- Regulatory considerations of biopharmaceuticals
- Application of regulatory principles
- Advances in regulation: biosimilars
- Advances in regulation: advanced therapies
Speakers
Adekunle Onadipe
Dr Adekunle Onadipe is an Associate Research Fellow in Bioprocess R&D, Cell Line Development at Pfizer Inc. USA. He leads a group of scientists responsible for the construction, development and characterization of mammalian and microbial cell lines for biotherapeutics and vaccines production. His group is also involved in the scale-up of bioprocesses from bench top to pilot scale bioreactors and process development for the establishment of cell banks to support the manufacture of biopharmaceutical products for early phase clinical trials.
Kunle joined Pfizer Limited in the UK in 2005 in Discovery Biology with responsibility for optimizing cell culture processes for the production of cell-based assay reagents. Prior to this he worked for 15 years at Lonza Biologics plc., in Slough UK where, as a Principal Group Leader in cell culture process development, he was responsible for constructing and developing production mammalian cell lines and culture processes, subsequently transferring them to full-scale production for clinical trials.
A microbiologist by training, Kunle has been involved in the production of biopharmaceuticals for more than 30 years and has a broad experience of microbial and mammalian cell culture methods. He obtained his PhD in Microbiology from the University of Surrey, Guildford UK.
Adrian Haines
Dr Adrian Haines is a Senior Process Manager within MSAT at Sobi (Swedish Orphan Biovitrum). Adrian has extensive experience in generating mammalian cell lines suitable for the GMP production of biologics and is extensively involved in the scientific oversight of both upstream and downstream process development, and process characterisation studies prior to regulatory filings. He joined the company (then Novimmune, Switzerland, subsequently acquired by Sobi) in 2015 and prior to this he worked at Lonza Biologics in the UK working on projects to develop new technologies and processes for generating manufacturing cell lines. Before that he worked for ML Laboratories/Cobra Research developing UCOE technologies for the expression of proteins in mammalian cells and at Therexsys Ltd, developing antibody targeted gene therapies. Prior to this he worked at Celltech Research Ltd, generating radiolabelling and cross-linking technologies for antibodies. A biochemist by training, he has been involved in the protein chemistry and production of monoclonal antibodies ~30 years, starting with his PhD where he generated monoclonal antibodies (using hybridoma technology) for the diagnosis of prostate cancer. He received a biochemistry degree from Imperial College, London, and his PhD from St Thomas’ Hospital Medical School, University of London. He is currently based in the UK.
Robert Alvarez
After completing his degree in molecular biology at the University of Reading, Robert Alvarez has been at Lonza Biologics for 17 years, of which 14 were spent working in the product stability group and 2 as Head of Business Planning and Innovation within Analytical Services (AS). Most recently he has accepted a new role as Site Head of Digital Transformation spearheading Lonza’s digitilisation strategy. Within AS he was a Subject Matter Expert responsible for the design and implementation of forced degradation and formulation studies, directing stability programs for multiple products and establishing standards for stability, as well as supporting stakeholders and customers. As analytical lead for mAb and non‑mAb programs, he has provided technical and advisory support for CMC development of biopharmaceuticals from pre-clinical through to clinical phases, including successful BLA licence applications.
Rhydian Howells
Rhydian Howells, associate director of regulatory affairs at Diamond Pharma services a Propharma group company. 20 years’ experience in the industry, 10 years at a large contract manufacturer developing manufacturing processes and analytical offerings for biological products followed by 10 years in regulatory CMC roles supporting clients with clinical development and marketing authorisation activities for large molecules and advanced therapies.
Mardon McFarlane
Mardon McFarlane currently works as a Director of External Manufacturing for the gene therapy company AAVantgarde Bio. Mardon is a co-founder of a consultancy, Taxo Bioscience, that specialises in supporting pre-clinical and clinical stage biotech companies, by ensuring they make the correct, impactful decisions early in their journey to bring life-changing therapies to patients. Mardon specialises in the CMC aspect of drug discovery and has been involved in notable drug approvals during his 18+ years in the industry. His experience in the biotechnology sector started with biologics but over the last 11 years he has migrated to the cutting-edge sector of cell and gene therapy. Mardon’s career has been focused on the processing aspects of drug manufacture and has spanned process development, technology transfer, scale up and large-scale manufacturing. Mardon holds an MEng in Biochemical Engineering from University College London.
Lekan Daramola
Lekan Daramola is an independent consultant who specialises in supporting biotech companies during the critical early drug development activities, enabling successful preclinical and clinical decisions as they develop new drugs for patients.
Lekan has extensive experience working in the biopharmaceutical industry, with over 26 years contribution to different areas of biologics drug development. Lekan’s experience spans lead drug molecule selection to regulatory submission. His expertise includes molecular biology, mammalian recombinant protein expression technologies, cell line development and early CMC support. In addition, he also has expertise in the development of novel drug modalities like nucleic acid drugs/vaccine (RNA, DNA) as well as AAV (viral vector) production platform development.
Prior to his current role, Lekan was a Senior Director at AstraZeneca, managing mammalian expression activities, the development of nucleic acid and AAV production capabilities to deliver preclinical and clinical drug development goals. Lekan hold a M.Sc. in Medical Microbiology from the University of Surrey.
Daniel Rowe
Dan is a European and Chartered UK Patent Attorney. He joined Dehns in 2001 after completing a BSc (Biochemistry; first class) and then a PhD in molecular cell biology, both from the University of Bristol. He became an Associate of the firm in 2008, Senior Associate in 2018 and was made a Partner Dehns’ Biotechnology and Life Sciences Group in 2023. He now heads the Oxford office Biotechnology and Life Sciences practice.
Using his background in molecular cell biology, Dan deals with patents and formulates IP strategies across the full spectrum of industrial and medical biotechnology. Within the health sector, he has a particular focus on molecular medicine (including therapeutic viruses and gene therapy vectors); molecular diagnostics, biomarkers and personalised medicine; pharmaceuticals (human and veterinary); drug repurposing/further medical uses; medical devices; advanced drug delivery (drug uptake enhancers, nanoparticles, nucleic acid/virus vectors); and wound healing products. His industrial practice includes technologies for protein purification from blood products; advanced cell-factories for the industrial production of proteins; microorganisms for oil spill clean-up, and surface sanitisation products. Dan also handles cases directed to microbiological and non-microbiological processes for the production of poly/oligosaccharides and engineered enzymes for removing contaminating nucleic acids from solutions.

