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Biologics Manufacturing

cGMP Plasmid DNA and Protein Production

Althea has unparalleled experience in producing plasmid DNA for vaccines and gene therapy products.  Our cGMP Manufacturing group specializes in the production of plasmid DNA and protein products for Phase 1-3 clinical studies.  With Althea, you’re not just partnering for the scalable fermentor capacity up to 1,000L, but for the opportunity to leverage a tremendous level of expertise and experience that has been demonstrated through an extensive track record of > 250 cell banks and > 150 lots of cGMP biologic drug substance.

After initial cGMP production, we then have the ability to easily and rapidly scale the process to meet increasing volume requirements for your product.  To assist in efficiently advancing your product candidate through the clinic and onto the market, you’ll have a highly experienced technical team, a champion for your product, and 30L, 100L, and 1,000L microbial fermentors working for you every step of the way.

PROJECT MANAGEMENT & BUSINESS PROCESS
Working with you from start to finish.

QUALITY & REGULATORY
Taking pride in our history of quality.

Integrated
Value

Protein Analytics /
Stability Testing

Having biologic manufacturing and analytical development working hand-in-hand and at a single partner will greatly shorten the time required to produce cGMP product.  Learn More

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Aseptic Fill & Finish

Forget about shipping valuable API from facility to facility and qualifying additional vendors.  At Althea, after producing and formulating your API, we can fill your clinical or commercial drug product into vials or syringes.  Learn More

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