Global Analytical Services
Focus on Souderton, PA facility
Our state-of-the-art labs support drug substance (API) and drug product (finished product) analytics across all phases of clinical development and into commercial release.
We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances. Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.
30 analytical staff supporting:
• Method development
• Limited ICH method validation for development use
• Full ICH method validation for commercial use
• Formal method transfers from client or third-party sites
• Release of clinical supply materials
• Release of commercial product
• Stability study design and execution
Analysis of a wide range of test articles including:
• Small molecule API
• Peptide API
• Solid oral dose – tablets and capsules
• Over encapsulated products
• Inhalers
• Medical devices
The Almac advantage over traditional CDMO service providers
Skillset
Highly experienced team working on a wide range of methods across all phases of development with a focus on problem-solving
Flexibility
Agile lab with flexibility to work on different products and methods for all sizes of customers from large pharma to small biotech
Delivery
In 2020 the lab performed and successfully executed projects ranging from early clinical to commercial. Encompassing all aspects of method development and validation through to QC testing and ongoing stability studies