Manufacture of Biotherapeutics and Biologicals Consultancy

Consultancy in manufacturing biotherapeutics, therapeutic proteins, biologicals and peptides for clinical trials, including bioprocess development and GMP manufacture

Whole cells, receptors, enzymes, proteins, peptides, monoclonal antibodies and their genetic precursors are all at the cutting edge of drug development. However, one of the most difficult activities confronting the development of these medicines is to turn a research-based process into a Good Manufacturing Practice (GMP) manufacturing process to support early stage clinical trials. I have helped many clients to work with contractors and/or their in-house capabilities to develop processes to manufacture proteins, peptides and biological products for clinical trials within rigorous time and cost targets. I am confident that my broad experience in the manufacture of biotherapeutics products can make sure that your product is on a fast track to the clinic.

My Experience
My bioprocessing experience spans over 30 years. Starting with protein isolation and microbial fermentation, I moved on to isolate hormones from mammalian cell cultures. In the early 1980s, I was one of the first to work with genetically engineered cells and to isolate their protein products for use in the clinic. Since then I have managed groups involved with both mammalian and microbial culture, the isolation of proteins, peptides and biologicals, derivatisation, analytical development, specification setting and compliance with GMP regulations. I then directed their integration into successful manufacturing processes. This experience means that I can bring both the practical and managerial experience needed to cover all the complex and interlocking operations required to develop a process to produce proteins for early stage clinical trials. 

Biotherapeutics Manufacturing Expertise:

Contact me now to discuss how my 30 years’ experience in bioprocess development for protein and biological manufacture can help you keep your biotherapeutic on the fast track to the clinic.

Case Studies

cGMP Cell Culture Pilot Plant

A German start up company wanted to evaluate whether it was more cost effective to outsource cGMP production of recombinant proteins by mammalian cell culture, or to build an in-house facility. My task was to provide the engineering group with a general area layout, equipment, people and product flow, and air quality scheme for the manufacturing suite. This information allowed them to consider the capital cost of the facility. I then listed all the capital equipment for up-stream and downstream processing, consumables and labour cost required to set-up and run the facility. I was able to point out the need to take into account the additional costs for process development and analytical labs. As a result of this input, the client decided that despite the local cash incentive to build the unit, outsourcing was the best solution.

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Bioprocessing Cost Model

A UK university innovation company wanted me to evaluate the potential manufacturing cost of making a chemically modified peptide by rDNA technology. The peptide was previously made by peptide chemistry but this route was proving too expensive. I proposed making the peptide as a protein fusion in E.coli as the most effective route. We then built a comprehensive cost model based on the client’s estimated initial market need. An enzyme technology solution was proposed for the chemical derivatisation step which was shown to cost less than 30% of the chemistry route. I am now helping the client find a suitable contract research organisation to carry out the process development.

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Bio-Pharmaceutical Project Planning

A mid-sized Danish pharmaceutical company, with little experience of therapeutic protein manufacture, wanted me to assess their project plan for making such a protein.  Through my experience in fast-tracking such process development steps, I was able to advise them on all the parallel activities that would be required to pursue such a project. I also advised them to outsource the project to an experienced contract research organisation (CRO). This advice helped the client to create an achievable project plan and timeline for the project.

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Dr Steve Brewer
Cells Biochemicals Proteins
Bioproducts Technology Consultant

Stephen J. Brewer, B.Sc. Ph.D.

Case Studies
A German start up company wanted to evaluate whether it was more cost effective to outsource cGMP production of recombinant proteins by mammalian cell culture, or to build an in-house facility....more>
A UK university innovation company wanted me to evaluate the potential manufacturing cost of making a chemically modified peptide by rDNA technology. The peptide was previously made by peptide chemistry....more>
A mid-sized Danish pharmaceutical company, with little experience of therapeutic protein manufacture, wanted me to assess their project plan for making such a protein.....more>