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 or Protein R&D Drug Manufacturing
-
Research or Clinical Drug Substance (API)
-
Formulated Clinical Drug Product
-
Synthetic Chemical Method
-
Biosynthetic Methods (Bacterial, Insect cell, Mammalian cell expression)
-
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
- Lyophilized or Liquid
- Sustained Release Formulation
- Implant, Microspheres, Collagen
Design & Development of Research Reagents and Multifunctional Antibodies
- Compound Detection or 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 Contract Laboratories
Guidance on Setting Appropriate Specifications for Drug Substance and Drug Product
Design and Implementation of ICH Stability Studies
- Drug Substance (API) and Drug Product
Establish Drug Development Reports and History
Write and Review CMC Section for Regulatory Filings
-
Participate in Meetings with FDA to Discuss or Defend 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
