Early Phase Pharmaceutical Drug Product Development

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Early Phase Pharmaceutical Drug Product Development

Almac’s experienced formulation development scientists can develop a range of oral dose formulations to support your early phase clinical trials.

With both non-GMP and GMP facilities, flexible and efficient solutions are provided to develop a fit-for-purpose formulation and manufacture early phase clinical trial materials.

For phase I First-in-Human (FIH) supplies, we offer a range of solid oral dose solutions:

  • Drug in Capsule
    • Manual hand filling / capsule boards
    • Xcelodose 600S precision powder micro-dosing
  • Drug in Bottle
    • API / powder in bottle
    • Co-solvent screening, instruction for reconstitution & in-use stability
  • Conventional solid oral dose presentations
    • Manufacturing of prototype tablets, capsules & powders

We have a range of technology available to work with APIs with varying properties:

  • Dry blending
  • Dry granulation / Roller compaction
  • Wet granulation (aqueous and solvent capabilities)
  • Encapsulation (Xcelodose)
  • Compression
  • Coating (aqueous and solvent capabilities)
  • Potent processing 

When understanding API properties is critical to developing a suitable formulation for early phase First in Human trials, our physical sciences group, who work closely with our formulators, can gain full insight into the unique physiochemical properties of your API. 

Our comprehensive chemical and microbiological laboratories fully support all phases of clinical trials providing analytical method transfer, analytical method development/optimisation/validation and cleaning method development and validation for solid oral dosage form development and clinical manufacture alongside stability testing and release of clinical supplies.

When we develop manufacturing processes, our scientists look to the future to ensure your formulation can be scaled up for later stage clinical supply.  Working with the same dedicated project manager and multi-disciplinary team, guarantees scientific continuity as your product progresses through its clinical trials.   

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