Many early-stage biotech. companies do not have in-house experience of developing scalable manufacturing processes. Mbio can provide this expertise and guidance to become an interim part of your development team. Not only can we provide guidance on appropriate bioprocess development paths, but we can also actively mentor and develop your scientific teams to enable rapid future pipeline product development. Areas where we can provide significant value include:
- Upstream process development; eukaryotic and prokaryotic cells, including high-containment organisms
- Downstream process development
- Bioconjugate development
- Analytical method development
- Practical implementation of statistical experimental design and QbD approaches
- Rapid process development methods
- Process scale-up
- Process and analytical transfer to GMP manufacturing
- Extensive experience with a wide-range of product types including enzymes, therapeutic proteins, vaccines, live-viruses, live-bacteria and conjugated products including Antibody Drug Conjugates (ADCs)
Biopharmaceutical product development
Planning to take a new biopharmaceutical into clinical development for the first time is a daunting task for project teams. Not only are the large-molecule products themselves complex, but so are the regulatory agencies expectations of the development requirements ahead of first-in-man studies. This leads to complex development programs with many different facets having to be planned and executed in a coherent, coordinated and well thought out fashion. By applying our extensive hands-on experience of developing many different bioproduct types, we can enable teams to better plan and implement product development programs. Our aim is always to apply our experience and expertise to prevent many common mistakes which less experienced groups can make and therefore speed up the development path through the clinic.
We can provide consultancy and interim management of a number of strategic aspects in the biopharmaceutical industry. Our strategic experience include:
- Acquisition target company technical due diligence
- Technology due diligence; including product technology
- Process development and manufacturing equipment vendor assessment
- Product investment rationale development
- Manufacturing strategy development
- Contract Manufacturing Organisation technical due diligence
- Development laboratory and GMP manufacturing facility design
- Development team structure and mentoring
- Early-stage company development planning