AAIPharma Services/Cambridge Major Labs Announce Integrated Offering for Solid State Chemistry and Formulation Development

AAIPharma Services Corp./Cambridge Major Laboratories, Inc., a provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, has announced an integrated service offering for solid state chemistry and formulation development to help the pharma/biotech industry meet important milestones and maintain stability in drug development. ProForm Select™ aligns the company’s solid-state, process chemistry and formulation development centers of excellence in Weert, The Netherlands, Germantown, Wisconsin and Wilmington, North Carolina.  These groups are focused on designing efficient, robust and scalable processes to progress Active Pharmaceutical Ingredients (APIs) from early development to final dosage form. 

The company’s integrated end-to-end offering provides solutions for APIs and drug products at every development stage.  For clients this means superior science and full attention at every stage of development. From determining the appropriate salt selection and robust process chemistry to commercial consistency and second supplier qualification, the company’s drug product and API development experts work in parallel to specify and define the critical quality attributes that are the key to product success. This results in significantly reduced timelines that aid in the advancement of products through the clinic to provide commercial success.

ProForm Select™ Offers and Program Deliverables:

Concept Through Clinic  

  • Scalable synthesis route
  • Molecular characterization including solid state
  • In depth assessment of the target product profile
  • Support of regulatory filings
  • 35% faster timeline than industry standard

Commercial Level Control

  • Scalable commercial process
  • Stable and robust process chemistry and drug product development
  • Integrated evaluation of drug substance and drug product target product profile
  • 35% faster timeline than industry standard

Commercial and Secondary Supply

  • Optimization of commercial process to reduce cost of goods, increase efficiencies
  • Line extension support
  • De-risking molecule by applying QbD principles
  • 45% faster timeline than industry standard

"We are excited to announce this integrated offering, which couples solid state, process chemistry and formulation development, allowing AAI/CML to make a value-added impact in our customers' progression towards clinical and commercial success. Our centers of excellence in Weert, Germantown and Wilmington are geared toward finding proactive solutions to address the increasing API process and Drug Product formulation development complexity of clinical candidates," stated Syed T. Husain, Chief Commercial Officer.

 

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