Pisgah Labs delivers small-scale commercial API manufacturing services ranging from low kilo quantities. We are ideally suited to meet the needs of a low volume drug substance (e.g. for orphan diseases), right up to the multi-tonne quantities required for high volume commercial supply.
We have pilot and full-scale production facilities available and are ready to manufacture the larger quantities needed for many projects.
When scaling up a project, we offer dedicated scientists and rapid tech transfer between sites supporting our GMP manufacturing teams. Both sites have a proven track record of successfully validating processes at the required production scale and are fully supported by Pisgah Lab’s quality assurance (QA) team that maintains the highest level of quality standards.