Clinical Services

As you progress on the drug development journey and require clinical grade material, Avecia is able to manufacture gram to kilogram quantities of your oligonucleotide compliant with US and European GMP guidelines. Transitioning from a preclinical to Phase I supply requires some initial process and analytical development to ensure that the manufacture is well documented and that the analytical tests will reasonably characterize the product. In most cases, focus is on a rapid turnaround time; therefore generic manufacturing and analytical methods will be used as appropriate. Batch records and standard analytical reports are generated in addition to a TSE/BSE compliance statement.

Moving into the later clinical phases, significant emphasis is placed on process and analytical method development to ensure a robust commercial process. Process development will start to identify and define key process parameters, using a Design of Experiments (DoE) approach. Process development reports will be written to detail process changes and the scientific basis for these changes. Our analytical development group will recommend and perform phase appropriate methods verification. Typically, purity and other process variables are tightened, ensuring robustness, quality and high yield.

Avecia’s familiarity with maneuvering around the pitfalls of the drug development journey is an asset to you, our customer. We have significant process development and validation expertise with oligonucleotide-based API’s, which translates to reduced time and cost for our customers.