 Developers of new biopharmaceuticals often times find the manufacturing process competing with the necessary focus needed on research studies. These challenges can delay getting
promising products into the clinic because they cannot be made
in sufficient amounts to meet commercial needs.
Process Development and Validation
To get your product ready for production, Introgen has
developed a line of services to ensure that the product you are
testing in cell culture or animal studies can be made in sufficient
quantity to supply future needs in clinical trials and ultimately for
commercial introduction. These services include:
- Vector Construction
- Plaque Purification
- Process Scale Up and Qualification
- Cell Line Generation and Testing
- Virus Bank Generation and Testing
Assay Development and Validation
Assays are critical tools for monitoring the manufacturing process
and ensuring product quality. While some assays are important for
verifying product integrity, others may ensure that the product
has retained its biological function throughout the scale-up
process. Introgen has developed the assays and know-how to
meet the strict requirements of regulatory agencies to support
product approval.
Regulatory & Clinical Services
There are critical regulatory decisions along the drug development
path that are not only necessary to enter the clinic, but also
key determinants on how those trials will be conducted.
Through the company’s own product development experience,
Introgen has assembled an experienced and knowledgeable
team to overcome the regulatory and clinical challenges to ensure your product receives the best opportunity for success.
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