Smart Process Development.
It is costly in both time and money to perform process development experiments, even at 1000 fold scale down of the final commercial process and it is therefore important that the approach is based on a rational foundation of good process science and incorporates QbD form the outset. Depending on your needs and in house team, BioReport can provide a range of services such that at the end of the initial process development exercise the team will be in a position to:
- Select an approvable Cell Line with a productivity capable of supporting a cost effective commercial manufacture
- Define Fermentation/Cell Culture Conditions which are scaleable and commercially viable
- Define an Infection Protocol [virus products] which is scaleable and commercially viable
- Recommend a robust scaleable Primary Recovery strategy which removes the bulk of non-product related contaminants from the process stream
- Recommend a Separation approach which is productive and cost effective and delivers formulated bulk drug substance at the required quality
- Provide guidance on a process strategy which can operate at scale using standard equipment and with holding steps allowing manufacture within the operational parameters of your facility.
BioReport has advised a range of biotech companies on process development strategy from initial expression studies and early research to development of commercial manufacturing processes.
Smart Project Management.
We have experience in managing a variety of development programmes from small molecules through protein therapeutics to DNA, Virus and Stem Cells and from the late research stage through to commercial. We can help you develop project plans, analyse and troubleshoot existing programmes and provide interim management for early stage projects. Recent assignments have involved advising internal teams on managing a programme for the development of cytokine products, antibody fragments and pegylated protein products.
We can help you answer the following questions:
- Are the needs of the project fully defined and is there an integrated timebased plan?
- Are there clear responsibilities and accountabilities defined and are the staff aware of these?
- How will you know if your plan is on track in terms of time and cost?
- How effective are the tools you use to present project status to your Board /investors /other stakeholders.?
- Do those staff involved appreciate the impact of their contributions on others involved in the project.?
- Is the critical path through the project analysed and the risks, technical, timeline and financial impact understood?
Smart Tech Transfer.
From the outset we ensure that answers to the following questions will be understood.
- Is the process to be transferred fully understood? –
- Is there assumed “local knowledge” which might not be written down?
- Is there an agreed procedure for technology transfer which is clearly understood by both the transferring and receiving groups?
- Are there clear responsibilities and accountabilities defined and agreed for the transfer process?
- How can risks be minimised through effective training and sharing of critical information?· How will we know if the transfer activity has been successful?· How will we document the transfer activity in a GMP compliant manner?
- What management systems have been established to ensure that any plans are executed according to schedule?
- How do we effectively troubleshoot the process if something goes wrong?
GMP Manufacture
David Thatcher has 20 years experience in managing clinical manufacture to GMP standards and has advised and participated in many meetings with the FDA and MHRA regulators. We are able to provide help in
- Select appropriate, or evaluate your current, GMP contract manufacturer(s) and other key components and suppliers within the supply chain.
- Design and develop your GMP Manufacturing strategy.
- Prepare CMC documentation for regulatory submission.
- Provide interim management support in managing a CMO.
- Review an investigational drug GMP manufacturing process with a view to identifying limitations, compliance and risks.
Business Management and Strategy.
David Thatcher has a successful record in biotech business development having founded and launched a start-up contract manufacturing business with a turn over of <$100k and developed that business as a profitable public microcap company making >$1.5M profit p.a.
We can help you develop your business plan, stress test and evaluate your existing plans and technology, provide interim management and also prepare Grant/Award applications and investor presentations.