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Biologics Manufacturing

Formulation

Whether your drug substance is destined for bulk storage or for finished product, we will formulate your product to the specific needs of your molecule and development program. At Althea, we have extensive experience with complex formulation processes. In formulating drug product, we have special expertise in aseptic processing, formulations such as liposomes & nanoparticles, conjugates, crystallized proteins, protein concentration/buffer exchange, adjuvants, and viscous products. We leverage the use of single use mixing systems, temperature control with heating or cooling, tangential flow filtration, high pressure fluid processing (homogenizers and microfluidizers) and static mixers, and can perform sterile filtrations on the scale of syringe filters up to large capsule filtration.

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

QUALITY & REGULATORY
Taking pride in our history of quality.

Case Study

Following cGMP manufacturing of the protein therapeutic in E. coli, the drug substance was formulated aseptically into a crystallized protein complex. Validation of sophisticated process skids was accomplished to generate this product.

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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