|Ridge Biotechnology Consulting, LLC
Product Development Consultants
Providing strategic and tactical advice and direction for the development and
manufacture of biotechnology and pharmaceutical APIs and drug products.
- Process development
- Analytical development
- Protein and carbohydrate analytical chemistry
- Formulation development
- Manufacturing of APIs (biologics and small molecules)
- Manufacturing of drug products
- Quality Assurance
- Audit raw material vendors, control (compliance) systems, manufacturing
facilities (contract and in-house), testing facilities, labeling and packaging
- "Person in the Plant"
- Preparation of the Chemistry, Manufacturing and Controls (CMC) sections of
- Contracts negotiation
- In-licensing and out-licensing due diligence
Dr. Patrick Gearing has an established track record of working with client companies
to manufacture of protein (MAbs, Mab conjugates, PEGylated proteins) and small
molecule therapeutics appropriate for clinical development. Dr. Gearing routinely
works with world-leading contract manufacturing organizations (CMOs), using
industrial experience to help clients overcome development and manufacturing
challenges unique to product. Dr. Gearing has product development experience in
several regulatory jurisdictions including the US, Europe, Japan, Canada and
Prior to founding Ridge Biotechnology Consulting, LLC (in 2004), Dr. Gearing was
Director of Pharmaceutical Development and Quality Systems at Seattle Genetics, Inc.
Additional industry experience has also included positions at Coulter Pharmaceutical,
Inc., PDL BioPharma, Inc., and Immunex Corp.
t: +1 206 706 0096
c: +1 206 679 3995