Biopharmaceutical

Development

Consulting

Our Focus


Independent Review of Program Data

  • Identification of a Suitable Development Molecule
  • Fill in Development Gaps and Plan Forward


Selection and Management of Peptide, Protein and Antibody Drug Manufacturing

  • Research or Clinical Drug Substance (API)
  • Formulated Clinical Drug Product
    • Synthetic Chemical Method
    • Biosynthetic Methods (Mammalian cell expression, Bacterial, Insect cell,)


Compound Specific Analytical Methods Development

(Stability or Function Indicating)

  • Expertise in All Current State-of-the-Art Analytical Peptide & Protein Methods:
    • HPLC, PAGE, Western Blot, IEF, Peptide Mapping, Mass Spectrometry, LC-MS, CE


Pre-Formulation, Clinical Formulation Development

  • Liquid or Lyophilized
  • Sustained Release Formulations
    • Implant, Microspheres, Collagen


Design & Development of Research Reagents and Multi-functional Antibodies

  • Compound Detection, Quantitation (Western Blot or ELISA) or Activity Neutralization
  • Epitope Design and Selection


Development of Clinical Assays for Detection of Drug in Animal/Human Serum

  • ELISA or LC-MS Methods


Tech Transfer of Methods to GMP or GLP Contract Laboratories


Guidance on Setting Appropriate Specifications for Drug Substance and Drug Product

Design and Implementation of ICH Stability Studies

  • Drug Substance (API),  Drug Product and Placebo


Establish Drug Development Reports and History


Write and Review CMC Section for Regulatory Filings

  • Participate in Meetings with FDA to Discuss CMC Topics
  • Annual CMC Updates of Open INDs


Support Business Development Activities

  • In-Licensing: Program and Data Review
  • Out-Licensing: Preparation of Due Diligence Documentation of Product Development Activities