Manufacturing Process Development, Scale-up & Technology Transfer

Complimenting the drug delivery and formulation development process, 3D Pharma Consulting provides services to assist and manage pharmaceutical manufacturing process design, development, scale-up and technology transfer. We bring knowledge of pharmaceutical engineering, established and emerging manufacturing technologies, risk assessment tools and combine with regulatory and quality considerations to design and develop stage-appropriate solutions. Our Manufacturing Process Development, Scale-up & Technology Transfer services include:

  • Process appraisal and gap analysis
  • Risk analysis and mitigation strategies
  • Process development and scale-up to support progress through preclinical to clinical phases
  • Utilisation of Quality-by-Design principles and interpretation and application of ICH-Q8 and -Q9
  • Selection and management of CROs and CDMOs for production and analysis of clinical IMP
  • Arranging GMP audits of CDMOs
  • Coordinating clinical supplies
  • Writing of CMC sections of regulatory documents and assistance with scientific advice requests

What Our Clients Think

Paul has brought a wealth of knowledge across pharmaceutical formulation development, analytical chemistry and manufacturing science. He has a positive, problem solving and professional manner that, combined with his industry knowledge, has provided Innoture with valuable support during internal and client facing drug development activities. His collaborative and friendly approach considers how Innoture is organised and our aims for the company, whilst also being keen to get his hands dirty w...

Ken Jones

CEO | Innoture Ltd

I would highly recommend Paul as a consultant; he has an in-depth knowledge of the pharmaceutical industry across a broad range of areas. Paul is proactive and works with clients to understand their objectives, he helped us to initiate a structured plan on how to enter the pharmaceutical sector and build a sustainable business model.

Ruth Mayes

Director Global Business Strategy | Computomics GmbH, Tübingen, Germany

Working with Paul to develop long-acting injectable formulations has been an immensely helpful experience for us. Not only is he highly technically competent, but he is also incredibly easy to work with. His wealth of knowledge allows him to quickly understand any challenges we encounter and provide different methods to solve them in a timely manner. We greatly appreciate how he supports his suggestions with relevant documentation from the FDA, literature, or other credible sources, giving us...

Dr Karthik Raman

CEO | Persist AI, Woodland, CA, USA

Drawing on Paul’s track record of taking innovative processes from benchtop to GMP, we were delighted to work with him in preparing our technology for scale up. Paul understood our technology quickly, and provided us with a thorough analysis, relevant and practical advice and tangible output that was tailored to our needs as a small, but rapidly growing company

Dr Fran Crawford

CEO | SomaServe Ltd, Cambridge, UK

3D Pharma Consulting Ltd