BioDev Consulting LLC
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 and bacterial cell expression)
- Synthetic Chemical Method
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
- 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
- Implant, Microspheres, Collagen
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