PCT understands the challenges you face and has solutions

Whether you choose to outsource your manufacturing to PCT or manufacture in-house, PCT's compliance-focused services can support your needs at every stage of the product development process.

Our team of experienced cell therapy specialists work closely with our clients to provide comprehensive technical and scientific support. We offer consulting along the entire spectrum of cellular therapeutic development.

Your Options
There are a really only a handful of options for companies looking for consultants with cell therapy experience and expertise. There are some excellent regulatory consulting specialists with outstanding regulatory experience; there are some technical consultants with significant laboratory experience; and there are some generalists with many years of experience in the field providing a wide range of services.

Expertise with Experience
PCT provides a unique consulting solution. We bring to our consultations, years of actual product development experience, in a cGMP manufacturing environment, with commercialization milestones.

Progenitor Cell Therapy’s management team has over 135 years combined experience in cell therapy, built 5 cGMP facilities, and participated in over 50 regulatory filings in the US and Europe. The company has served over 100 clients, performed over 30,000 cell therapy procedures involving over 17,000 units of 20+ different kinds of cell-based products, approximately 5,000 of which have already been used for patient treatment.

Regardless of what other consultants you may be considering or have retained and irrespective of your preferred manufacturing strategy, consider using PCT to your advantage next time you are seeking external advice you would like to come from experts with experience.

Our Consulting Services

Product and Process Development

• Process development, optimization and scale-up
• Product characterization, product potency and product stability assays
• In-process and final product test method development
• Product shipping validation

GTP/GMP Manufacturing

• Facility design, construction, validation and operation
• Quality systems development and implementation

Regulatory Services

• Product development strategy
• Master File development
• Investigational New Drug (IND) applications
• Pre-clinical study design
• Chemistry, Manufacturing and Controls (CMC) development
• Biologic License Applications (BLA)
• Preparation/representation at regulatory meetings
• Regulatory submissions, amendments, supplements and reports

Business Development and Commercialization

• Strategic development
• Financial modeling
• Project management
• Technology evaluation and licensing opportunities