Early Phase Pharmaceutical Drug Product Development
Early Phase Pharmaceutical Drug Product Development
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, we offer flexible and efficient solutions to help you develop a fit-for-purpose formulation and manufacture early phase clinical materials.
Preclinical or Phase 1 First-in-Human solutions
With a proven capability of handling potent APIs and peptide pharmaceutical drug programs, our full suite of Xcelodose, All-Fill and specialized technologies help accelerate timelines whilst maintaining high quality.
| Direct API in capsule | API / Powder in bottle | Conventional oral dose presentations |
| • Xcelodose 600S precision powder micro-dosing | • All-Fill for ultra-low doses • Co-solvent screening, instruction for reconstitution and in-use stability |
• Manufacturing of prototype tablets, capsules & powders |
Our range of technology is available to work with APIs and highly potent APIs in high containment processing environments. This includes:
- Dry blending
- Dry granulation / Roller compaction
- Wet granulation (aqueous and solvent capabilities)
- Encapsulation (Xcelodose)
- Compression
- Coating (aqueous and solvent capabilities)
- Potent processing
If you’re planning early PK, IND-enabling or Phase I-ready activities, our expert technical team can guide you to the fastest and most reliable path based on your molecule and timeline.
With comprehensive chemical and microbiological laboratories, our expert analytical solutions fully support all phases of clinical trials.
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.
Ready to scale up?
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.