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Protein Analytics
Stability Testing

Product Characterization

Althea has the experience and capabilities to provide a thorough understanding of how your molecule behaves over time.  We know how critical it is to understand your product at an earlier stage during development so that necessary changes can be made in areas such as formulation, drug delivery, and vial to syringe changes.  We will work with you to design a product characterization program, and provide guidance on methods and assays to ensure your product’s consistency and quality.

CORE METHODS & EXPERTISE

Althea’s product characterization methods can be applied to protein, glycoprotein, peptide, and monoclonal antibody products.

  • Primary Structure Analysis
  • Purity Profiles
  • Variant Purification and Identification
  • Aggregation Analysis
  • Carbohydrate Analysis
  • Immunochemistry
  • Conjugated Protein Analysis

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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