CMC

We have in-depth experience and expertise in developing CMC and manufacturing strategies for large molecule. We have also managed and overseen the CMC development and cGMP manufacturing from pre-clinical into late-stage development.   more...

Cell & Gene Therapy 

With expertise across the cell and gene therapy life cycle our range of approaches will help tackle the challenges you might face in the development of cell and gene therapies. We’ll work with you to accelerate your projects, helping your cell and gene therapies to be safer, more effective, scalable and affordable.

Process Development

Integrating upstream and downstream process development strategies for a variety of expression systems- mammalian, microbial and cell free. Products include therapeutic antibodies, difficult to express protein and molecules, cell and gene therapies, and exosomes, etc  more...

Technology Transfer

Tech transfer is a complex operation carrying business, regulatory, product quality, and technical risks. Each TT case is potentially different and requires a tailored approach. that's where BPTC can assist and mentor you and your team. more...

Clinical and Commercial Manufacturing

Commercial manufacturing is characterised by process and cleaning that are operated with full validation, as are the analytical methods. Clinical does not require process, cleaning or analytical methods to be validated.

Computer Software Assurance

CSA represents a step-change in computer system validation and aims to make the adoption of compliant computerised system tools simpler, more streamlined and more straightforward.
Instead of producing a lot of documentation to validate a digital system, regulated companies should instead adopt an agile and risk-based approach.  more ....