Consultancy

Technical Advice/    Project Management

Interim   Management

BioReport Consultancy provides a technical resource covering all the critical aspects of the biopharmaceutical development programme and product life cycle.  

Project Management  [click here]           Process Development [click here]   

Business Development [click here]         Technology Transfer [click here]

                                           GMP Manufacture [click here]

EMEA Guidelines on quality documentation for biological IMPs is out for consultation  click here to download

BioReport Consultancy can provide CMC advice relating to the manufacture all the major types of biopharmaceutical product and we have unique experience on manufacture of Stem Cell products, Live Bacterial Products and Vaccines, Virus Products and Plasmid DNA. BioReport Consultancy is an independent consultancy focussed on biopharmaceutical manufacturing and in aiding, and supporting companies, in the clinical development of biotechnology products.  BioReport Consultancy brings together over fifty years of professional experience [click here for current staff]  to help you maximise your opportunity for success through minimisation and control of risk.

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Process Development

We have steered many products from research phase scale up to phase 3 clinical trials and have experience working within regulatory guidelines for FDA IND [Investigational New Drug Application] and MHRA/EU CTA [Clinical Trial Application] submission. We can provide expert advice on overall process strategy, support management in the implementation of development programmes or design and initiate complex process development programmes. Our previous experience covers cell culture / fermentation, all aspects of downstream processing from primary recovery through chromatography to formulation development and process validation.

Hasty adoption of inappropriate process technology can have far reaching consequences on the time-to-market, cost and on the profitability of the marketed product. The risk lies in the complexity of biopharmaceutical products themselves, the wide range of scientific disciplines required for their successful manufacture and the high cost of goods compared to more traditional drugs.

The Issues and Risks encountered in Process Development

Compared with conventional drug scale up and manufacturing, biopharmaceutical process science is still in its infancy. In the manufacture of small molecule drugs process development chemistry is rarely on the critical path. However, in the case of biopharmaceuticals it is almost always on the critical path. Process development success has an impact right through the product life cycle and good process development input is a strategic investment for the future enabling rapid scale up during development and cost effective commercial manufacture post launch. 
READ MORE ABOUT OUR PROCESS DEVELOPMENT SERVICES......·

Technology Transfer

Although often assumed to be straightforward, Technology Transfer ['Tech Transfer'] is often far from simple and failure can be expensive both in terms of cost over-runs and delays but also in terms of team morale and engendering a blame culture. Tech transfer is one of the most discriminating challenges facing any management team and we believe it essential that the transfer is effectively managed as a stand alone activity. We have wide experience in the transfer of technology both within and between organisations on both a national and international level.  We can provide help and support in the following areas:

• Transfer of research procedures or early stage process development from your facilities to a contract manufacturing organisation
• Transfer of technology from process development laboratories to a fully documented GMP manufacture within an organisation.
• Transfer of analytical methods from research labs to a GQCLP [Good Quality Control Laboratory Practice] laboratory.

The Issues & Risks in Tech Transfer  

  Problems arise in two major tech transfer activities :

• External transfer of research procedures or early stage process development procedures to external sites or to contract manufacturing organisations··
• Internal·transfer from process development into GMP Manufacture. The research/process development culture is different from that in GMP manufacture.

Transfer of a procedure directly from a process development lab to a CMO GMP division invariably leads to expensive delays and even the possibility of programme termination.

READ MORE ABOUT OUR TECH TRANSFER SERVICES....·

GMP Manufacture

GMP or Good Manufacturing Practice is the central element of a quality assurance system which is designed to make sure that the drug administered to the patient is of a reproducible standard. Although the GMP code is harmonised internationally for commercial product manufacture, there are regional differences in approach to the application of GMP to the manufacture of early stage biological products; depending on the type of product, indication and geographic location. A successful GMP manufacturing programme requires the successful alignment of a robust process, appropriate in process and end product testing and regulatory compliance.

The Issues & Risks in GMP Manufacture of Biopharmaceuticals

One of the constraints of GMP manufacture is that by its nature the code reduces flexibility in the manager's freedom to change or modify the process; including early in development where the quality of material used in Phase I safety and efficacy trials must reflect the quality and efficacy of material used in the earlier pre-clinical safety studies. This does not mean that changes cannot be adopted but that these must be introduced in a controlled manner [Change Control] and potential impacts on quality evaluated [Quality Risk Management]. This is a particularly important issue in Phase I/II manufacture and it is important to review the manufacturing process at an early stage as significant process changes can potentially lead to expensive delays e.g. if the regulatory authorities deem it is necessary to conduct additional toxiclogy studies.
READ MORE ABOUT OUR GMP SERVICES.....

 
Project Management

We have experience in managing a variety of development programmes from small molecules through protein therapeutics to plasmid 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.

The Importance of and Risks associated with Project Management

To achieve the desired goal, the development of a biopharmaceutical requires the combination of a broad range of technical, regulatory and clinical activities.  A typical project could require the management of inputs from·Research, Process Development, Analytical Development, Quality Control, QA and Regulatory, Manufacturing, Supply Chain and potentially Engineering teams – not to mention inputs from clinical research and commercial teams. Additionally you may decide to outsource many of your requirements to a CMO, CRO or other contract organisation. Management of such a programme requires a thorough understanding of the activities to be conducted and their interdependencies. Additionally it is necessary to know where you are in the process both in terms of cost and time, and have the capability of effectively communicating this to all stakeholders. Failure to manage an effective plan can result in catastrophic failures and delay.
READ MORE ABOUT HOW WE CAN HELP IMPROVE YOUR PROJECT MANAGEMENT SYSTEM

 Business Development

David Thatcher has a successful record in biotech business development having founded and launched a startup contract manufacturing business with a turn over of <$100k and developed that business into a profitable public microcap company making >$1.5M profit p.a. We can help you develop your business plan, stress test and evaluate your exisiting plans and technology, provide interim management and also prepare Grant/Award applications and investor presentations.

The key to successful business development
Effective communication is key to the successful development of your business.  The development and manufacture of biopharmaceutical products  involves highly specialised and advanced science and technology, an understanding of which can be demanding even for those within the biotech community. Your potential investors or partners may have far less an understanding and success in deal making comes through focus on the key deliverables and risk analysis and their clear communication.  Conveying the mesage whilst retaining interest and accuracy can be a demanding exercise.

READ MORE ABOUT HOW WE CAN ASSIST IN DEVELOPING YOUR BUSINESS