Almac is unmatched in its ability to manufacture clinical trial supplies and provide analytical support from its global locations in UK, Ireland, EU and Pennsylvania, USA.
Developing a drug is a costly and complex process where purity, safety and efficacy must be continually proven in order to meet strict regulatory requirements through clinical trials. Conducting analytical testing of drug product, comparator and placebo is an integral part of the clinical supply process and provides a valuable foundation for future drug development.
Analytical testing is a significant, critical, and sometimes unpredictable aspect of drug development. It not only has to be tailored to specific needs but delivered on time and within spec, enabling the successful launch of a clinical trial.
With over 50 years’ experience in providing analytical support to clinical packaging operations, we support your clinical trial analysis with additional data relating to:
We adopt a flexible approach and each project is protocol-driven and tailored to our clients’ requirements. Our wide range of instrumentation enables us to deliver fit-for-purpose solutions to match your testing needs.
Our full suite of analytical testing for clinical trials covers a range of product types including small molecules, peptides, biologics, conjugates, potent substances and controlled substances.
Our FDA, EMA and MHRA audited analytical laboratories provide release analysis for drug substance and drug product commercial supplies. Release testing covers all activities associated with carrying out the analytical testing necessary for the release of the product into trials including:
•Analytical method transfer
•Appearance, assay and impurities, dissolution and microbial testing
•Issue of GMP certificate of analysis
Communication and scientific continuity are key, whether your analytical requirements are stand- alone or form part of a drug development or commercial manufacture project. Our analytical scientists routinely work with drug substance and drug product formulation scientists, forming an integral part of the project team. This means they can share data and easily coordinate planning and scheduling to deliver maximum efficiency.
Clients who use Almac to release drug substance and drug product in the EU & US benefit from shortened transfer time, cost savings and minimised disruption thanks to scientific and procedural continuity.