Small Molecule API Development and Manufacture

Developing a small molecule API (active pharmaceutical ingredient) involves undertaking various chemical processes to ensure that the finished product meets the stringent standards for identity, quality, purity and strength required by regulatory authorities. Small molecule API development and manufacturing, therefore, can be a complex process, particularly when considering scale-up.

Almac’s strength in drug substance API development and manufacture is proven by being the pharma CDMO partner of choice for many pharma and biotech companies seeking integrated drug development solutions from molecule to market. Our technical expertise in complex API development, scale-up and manufacture, coupled with our extensive facilities enable us to offer integrated API contract manufacturing solutions from early phase clinical development to commercial API manufacture, which are fully supported by dedicated analytical and regulatory teams.

Almac has an excellent regulatory history with regular inspections by all appropriate regulatory bodies (FDA, MHRA) and our clients.

In addition to our core services, we offer numerous support capabilities, including: rapid implementation of chromatography for purification, containment equipment for potent compounds and micronisation to control particle size.  Our dynamic team successfully address many complex project challenges, and implementing our on-site biocatalysis  technology expertise is one example of our responsive solutions.