Government Drug Product Development Services

Pharmaceutical development covers the entire spectrum of activities from chemical process, pre-formulation, formulation and analytical development to regulatory support and clinical trial materials (CTM) manufacturing. Additionally, Albany Molecular Research Inc. (AMRI) offers sterile fill and finish capability – including syringe filling – in North America for clinical as well as small volume commercial markets.

Pharmaceutical chemical manufacturing from the kilogram to ton scale is accomplished by leveraging a global plant network and supply chain with internal assets on three continents: North America, Europe, and Asia. AMRI also has expertise in potent compounds and controlled substances in its North American manufacturing facilities. We are able to tailor the supply chain for production chemistry to meet the specific project deliverables of individual customers in terms of optimal speed and cost while appropriately handling process safety, regulatory compliance, and complexity.

Distinct Drug Development Capabilities

Distinct Drug Manufacturing Capabilities

Chemical Process R&D Capabilities

Working in state-of-the-art laboratories, equipped with the latest process and analytical instrumentation, AMRI’s scientists exceed expectations even on the most challenging projects. AMRI’s well-established team comprises key scientists and managers derived from large pharmaceutical and biotechnology companies, and local academic institutions.  Clients benefit from individual components of a development/manufacturing program, while also harnessing the synergies in the discovery segment within AMRI. Distinct process R&D strengths include rapid process optimization, route scouting, process safety hazard evaluations, custom and metabolite synthesis, and the design of experiment techniques, scale-up, and high potency expertise.

Drug Product Development Capabilities

AMRI’s drug product development strengths comprise applied acumen in the development of a variety of dosage forms, such as powder in bottles and capsules, as well as more advanced oral, topical, or sterile formulations.  The company’s efficient technology transfer processes ensure rapid delivery and flexibility. With AMRI’s effective processes, no handoffs are required because the development and manufacture of products are supported by analytical scientists, chemists, and quality experts.

AMRI’s clients worldwide rely on the company’s technical proficiency, commitment to the maximum quality and regulatory standards, flexibility, and customer-centric focus to advance their lead compounds through the drug development process, from bench scale to commercial production. State-of-the-art facilities are well-equipped for dosage-form production, chemistry studies, and material-science services.

Distinct Drug Product Development Strengths

Pre-Formulation Development

  • Salt, polymorph & co-crystal screening
  • Comprehensive material characterization
  • Crystallization engineering & process integration
  •  Excipient compatibility

Formulation Services & CTM Manufacturing

  • Oral dosage development & manufacturing
  • Xceledose technology
  • Liquid & suspension dosages
  • Powder in bottle (PIB) manufacturing

Aseptic Fill & Finish

  • Vial and syringe  filling
  • Liquid and lyophilized products
  • Biologics

Analytical Services

Pharmaceutical Development Case Studies

AMRI offers integrated pharmaceutical development services from API development; preformulation and material science; formulation development; Clinical Trial Material (CTM) manufacturing; Chemistry, Manufacturing, and Control (CMC)-enabling analytical development; and regulatory affairs services for investigational new drug (IND) / investigational medicinal product dossier (IMPD) filing. AMRI’s approach is to bring your candidate to the clinical study with an integrated scientific solution without unnecessary hand-offs, resulting in an earlier and more scientifically reliable study.

Download AMRI Development Case Studies