SAFC Pharma - Pipeline Partner for Complex API and Biologics Development and Manufacturing

SAFC Pharma® offers customers the rare combination of complex small molecule and biologics expertise, providing comprehensive support of product development and manufacturing programs.

From pre-clinical development to commercialization, including technologies that are just emerging into the marketplace, SAFC Pharma’s complete range of technical knowledge, capabilities and experience delivers effective and efficient manufacturing solutions that speed up the development cycle.

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.

Financial stability and life sciences experience

In difficult times, customers need a partner with the fiscal strength to be around now and in the future. Losing a supply chain partner due to financial instability could be catastrophic. With the financial backing of Sigma-Aldrich and 50 years of experience in the life sciences market, SAFC will continue to be available to support today’s ideas and tomorrow’s commercial products.

Passion for quality

SAFC’s nearly 1,800 employees operate in a culture that centres on a passion for quality. Quality and process improvement is engrained in all operations and we demand that our procurement partners uphold appropriate quality standards as well. SAFC continually analyzes its manufacturing processes to make them more efficient and safe for employees. We operate under the industry’s strict regulatory standards and have a complete understanding of our sourced raw materials.

Our facilities are designed to meet quality standards as well; our high-potency API manufacturing site was one of the industry’s first to be SafeBridge® certified, and our vaccine facility in Carlsbad, California, was designed to follow containment regulations while still maintaining flexibility.