Ridge Biotechnology Consulting, LLC
Product Development Consultants

Our services:

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  
    facilities
  • "Person in the Plant"
  • Preparation of the Chemistry, Manufacturing and Controls (CMC) sections of
    regulatory filings
  • Contracts negotiation
  • In-licensing and out-licensing due diligence


About us:

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
Australia.   
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.
Contact us:

t: +1 206 706 0096
c: +1 206 679 3995
e: pgearing@yahoo.com