Almac Adapt™ Just in Time Manufacturing Solution
Almac Clinical services understands that we live in a world that is always changing, always evolving.
Faced with a rapidly growing and ageing population, science is responding by developing innovative personalised medicines. With these positive advancements come challenges for not just patients and sponsors, but a high value, time sensitive clinical supply chain. Our Almac Adapt™ Just in Time Manufacturing enables full late stage customization of your clinical supplies by postponing packaging and labelling until the site or patient need arises.
This solution ensures finished patient kits are packaged, labeled and shipped only when needed, resulting in reduced timelines, wastage and product shortages to ensure budgetary and protocol efficiencies. This Just in Time Manufacturing solution was designed to meet the challenges of today’s trials and the trials of tomorrow, including gene and cell therapies, oncology trials, immunotherapy, rare and orphan diseases, adaptive trials, and expanded access/compassionate use/named patient.
Features and Benefits:
- Patient and site centric approach to meet variable demands leading to significant reduction of waste
- Maximise viability of pooled supplies, only labelling and packaging when the need arises
- Ability to quickly effect label change, such as expiry updates, regulatory, and protocol amendments
- Reduces study start-up by up to 50% as compared to traditional manufacturing
- Orders processed within several business days from the point of drug order receipt to dispatch
- Clinical supplies prepared in dedicated cGMP suites across all processing temperature conditions