Potent Processing and Manufacture
Almac Pharma Services understands the unique challenges associated with handling potent compounds. Our highly skilled team is equipped to handle a diverse range of Active Pharmaceutical Ingredients (APIs) and drug products utilising state-of-the-art facilities, equipment and technology.
We follow rigorous containment protocols to protect both our employees and the environment, ensuring both safety and compliance at every step. Processing high potency APIs in drug product development for clinical trial supply and small volume commercial products. Almac develops and manufactures oral dosage formulations containing high potency API from our state-of-the-art non-GMP and GMP facilities, with batch sizes ranging from gms to tons.
At Almac quality assurance and compliance is at the heart of everything we do. We adhere to strict regulatory guidelines and standards to ensure that your pharmaceutical drugs meet the highest quality and safety requirements. Our facilities are regularly inspected and audited by regulatory authorities to guarantee compliance with GMP and other relevant regulations.
Utilising our state-of-the-art containment technology
We have designed, manufactured and installed state-of-the-art containment technology to facilitate the processing of potent compounds in both our non-GMP and GMP pharmaceutical development facilities.
To contain airborne particulates, we have applied engineering solutions that employ rigid and flexible film isolator technology around the processing zones of equipment. Extensive dust monitoring exercises have determined the effectiveness of these containment solutions, demonstrating that we can process compounds with an OEL as low as 0.05g/m3/8 hours.
We have the capability to process potent compounds using a wide variety of processing techniques, which include:
- Dry granulation
- Wet granulation / fluid bed drying
- Tablet coating
From formulation, to scale-up, and commercial manufacturing, Almac Pharma Services is your trusted partner throughout the entire lifecycle of your drug product.