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SAFC Pharma
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Highly potent API manufacturing

With over $75 million invested in purpose-built high containment facilities over the past few years, SAFC leads the market in highly potent API manufacturing. Our capabilities for this specialized production cover the entire range of pipeline operations, from development to pre-clinical and commercial operations.

Using SAFC’s unique expertise in small molecule, biologics and high-containment we can meet our customers’ needs with highly potent bioconjugates and highly potent, fermentation-derived APIs.

Solid state chemistry and solid form research studies

We offer solid form research studies through our Pharmorphix® brand for every API we manufacture. Our expert scientific team works to investigate, understand and modify the physical properties of the drug substance to ensure patient benefit, rapid development and protection of intellectual property.

R&D services include polymorph investigation, salt selection, physicochemical property optimization, pre-formulation profiling, co-crystal investigations, classical chiral resolution and crystallization studies.

Viral vectors and vaccines

SAFC Pharma is the market leader in the clinical manufacturing of viral products. Using state-of-the art facilities in Carlsbad, California, these products are produced for therapeutic applications such as oncology, heart disease and CNS, in addition to next-generation vaccine candidates.

Antibody drug conjugation

SAFC Pharma has facilities to support the manufacturing of antibody drug conjugates – a mix of chemistries such as potent / cytotoxic APIs and linkers, and biologics. SAFC Pharma’s decades of experience in high-potent and linker technology, along with more recent investments in a variety of biotech processes, make SAFC Pharma a strong partner to develop this exciting new area of therapeutics.

API process development, technology transfer, pilot plant production and commercial manufacturing

Working closely with customers to keep up-to-date with the latest innovations, SAFC continues to invest in the technologies and processes that will best serve upcoming requirements. With experience gained from over 230 DMFs and nine FDA-validated, cGMP manufacturing centres, our large and small molecule portfolio covers niche technologies and a wide capacity range to fully support API advancement, from process development and optimization to technology transfer, pilot plant production and commercial manufacturing.
 
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