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AAI/CML unveil new offering for solid state chemistry and formulation development

AAIPharma Services Corp. / Cambridge Major Laboratories (AAI/CML) has announced today 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 our 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.

Our integrated end-to-end offering provides solutions for APIs and drug products at every development stage. For our customers 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, our 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

Syed Husain, chief commercial officer, said: "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."