BioProcess Technology Consultants | Process and Product Development

PROCESS AND PRODUCT DEVELOPMENT

BioProcess Technology Consultants’ extensive process development experience enables its clients to transition their products from discovery to the clinic and to commercialization faster and with less expense and risk. Whether your product is in pre-clinical development, clinical trials, or already on the market, we can help increase its value by identifying opportunities for yield, product quality, or scalability improvements, greater process robustness, cost reductions, and reduced processing times. Our expertise covers all aspects of CMC, including:

Microbial and mammalian cell line development
Drug substance and drug product process development
Analytical and assay method development and validation
Product life-cycle management
Process validation
Validation master plans
Viral safety plans
Tech transfer and scale-up
Pre- and post-approval comparability protocols
Setting phase-appropriate specifications and acceptance criteria
Formulation development
Stability studies
CMC regulatory strategy
Cost and process modeling, including new technologies, development path, and outsourcing

Our consulting team has experience in all aspects of biopharmaceutical manufacturing process technologies and operations. For drug substance this includes cell culture and fermentation, recovery, refolding, purification, and conjugation. For drug product, our experience includes vial and syringe filling, liquid and lyophilized formulations as well as specialty formulations like encapsulations.

In addition to process development, implementing suitable analytical methods to assess purity and stability are needed early in product development. We can help identify and develop these methods to meet regulatory expectations. We can apply scientific and regulatory understanding of analytical principles and prepare development, qualification and validation protocols and reports tailored to regulatory expectations at each stage of product development.

We provide a range of support options for all CMC activities including short, focused consultations on specific technical or regulatory issues to comprehensive management of the CMC development program.