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Protein Analytics
Stability Testing

Reference Standard Qualification

As your drug product progresses through the clinic, Althea will work on creating phase appropriate reference standards that set specifications and controls for assays used during the development of your product.  Our team is able to bridge new lots of reference standards to demonstrate equivalence.  Every time your drug product is manufactured, we will compare your drug product against the developed reference standards to determine that the product encompasses the same quality, purity, strength, and consistency.  Compliance is also built into our review system, with our quality group reviewing test results and issuing Certificate of Analysis or Certificate of Release documents.  By setting proper specifications for your reference standards, Althea will ensure that your drug product meets the same criteria for quality and consistency time after time.

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

QUALITY & REGULATORY
Taking pride in our history of quality.

 

Integrated
Value

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Biologics Manufacturing

Analytical development is the guide for biologic manufacturing .  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

Aseptic Fill & Finish

Forget about shipping your valuable API from facility to facility for each step of the manufacturing program.  Once you protein is produced and formulated, it can be readily filled into vials or syringes for clinical or commercial use.  Learn More

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