Parenteral Product Development Solutions
BioConvergence offers parenteral product development services covering all stages of the development cycle. We work with solutions, suspensions, emulsions, and lyophilized formulations, and on small & large molecules and cytotoxics.
Our development services include:
- Pre-formulation studies
- Formulation & process development, including compatibility studies
- Lyophilization cycle development and optimization, including:
- Complete thermal analysis studies with DSC and freeze-dry microscopy
- Accurate determination of Tg’, Tc, and Te
- Targeted pilot studies using a LyoStar IITM freeze dryer
- Determination of crystalline and/or amorphous character
- Analytical method development, validation, release and stability testing
- Pre-clinical and toxicology batch manufacture and packaging
- Technology transfer support to clinical and commercial manufacturing sites
- Counterfeit detection
Specific methods we offer in our state-of-the-art 2,500 SF cGMP analytical laboratory include:
- FTIR characterization of biomolecule secondary structure
- CE, HPLC, ELISA, LC/MS, and gel electrophoresis (CE-SDS, Bioanalyzer & SDS-PAGE)
- XRPD data collection In-Situ during lyophilization
- General characterization analysis: pH, Karl Fisher residual moisture, dissolved
- O2, osmolality, particle size, charge variants and pI determination
BioConvergence can customize and add services to meet your needs, so please contact us if you do not see the process or methods you are seeking listed above.
About BioConvergence Development Staff
The goal of the BioConvergence development team is simple, but important: to serve as a valuable co-contributor to the development and commercialization of new molecules and the improvement of existing drug therapies for you and your company. Our team wants to help you move your product through development and to the market with quality and speed.
BioConvergence’s highly experienced development staff:
- Has developed over 30 marketed products
- Is experienced in the biopharmaceutical development process, including work on peptides, proteins, and enzymes
- Is supported by an experienced quality and regulatory staff
- Is supported by project management professionals who ensure timely, on budget project completion
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