Production Options
Introgen has developed industrial production processes for
consistent manufacture of biological products that are transferable to your product. Introgen can produce at scales
for preclinical and clinical testing as well as commercial scales.
Production capabilities developed over 10 years include both
adherent and suspension cell processes.
Product & Technology Capabilities
- Adenovirus and other viral vector systems
- Non-viral approaches
- Adherent and suspension cell culture systems up to 100L
scale
- Large scale ultra/diafiltration
- Chromatographic purification
- Formulation and lyophilization
Aseptic Fill & Finish
Introgen offers fill and finish services such as stopper and vial
procurement, sterile fill, and labeling. Once your product is
ready for use, Introgen also provides materials management
services including storage, shipping and logistics support for
your product.
"Our project with Introgen was originally intended to be primarily
manufacturing, but Introgen has become a much more
valuable partner to Oncolys in developing our product.
Introgen has provided high-quality services to Oncolys including
process and cell line development, analytical methods,
qualified bank generation, representation at meetings with FDA,
and even creation of a pharmacy brochure. Introgen's broad
experience in gene-based biopharmaceuticals has been
instrumental in helping Oncolys meet its goals in development of
its first product."
- Yasuo Urata
President and CEO, Oncolys BioPharma, Inc.
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