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Protein Analytics
Stability Testing

Comparability Studies

Do you need lot-to-lot variation testing for your Phase III commercial validation batches?  Are you looking to make modifications to your manufacturing process?  Or perhaps you are looking to transfer your entire manufacturing process from another CMO to Althea?  Althea can design and perform comparability studies to ensure that your expressed molecule is the same as the molecule produced before any modifications were made.  This includes looking at your protein’s structure to evaluate if any subtle structural variations have emerged as a result of changes to your manufacturing site or process.

Whether your drug development program needs process modifications or is in search of a new partner for commercialization, Althea’s expertise in comparability study design makes the transition to the next stage as easy and efficient as possible.

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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