Sigma-Aldrich Corporation's custom manufacturing and services business unit, SAFC, has added more than 25 new raw materials to its portfolio of PharmaGrade products. Launched earlier this year, the PharmaGrade portfolio is comprised of over 65 high-quality buffers, amino acids and specialty chemicals, addressing the need for greater supply chain transparency and enhanced risk management for biopharmaceutical manufacturing.
PharmaGrade products come with a fully documented production history that highlights consistent and controlled processes compliant with GMP or SAFC 'Elite' grade documentation guidelines. All products in the portfolio feature formal manufacturer qualification, quality assurance review and release of every lot, change control notification, as well as quality and regulatory support documentation.
"We have had a tremendous response to the introduction of PharmaGrade and the positive benefits it delivers to our customers," stated Deborah Slagle, vice president of marketing and research development at SAFC. "We are able to offer raw materials that encourage quality by design in the early phases of development, while increasing our customers' and potential customers' confidence in the raw materials they are using. More importantly, this line of products saves time for clients that are looking for hard-to-find products with readily available documentation."
The April 2012 acquisition of Research Organics has enabled SAFC to increase its PharmaGrade offering, while complementing the Company's existing raw materials portfolio. The expanded manufacturing capacity made available by Research Organics also enables SAFC to provide customers with dual sourcing of biological buffers. With the addition of dedicated resources and increased capabilities to the PharmaGrade product line, the transition of Research Organics into SAFC has proven beneficial for customers and successful for SAFC.
"Our goal is simple. We want to be recognized as the supplier of choice within the biopharmaceutical and high technology industries we serve," added Gilles Cottier, president of SAFC. "The acquisition of Research Organics supports us in fulfilling this goal in the biopharmaceutical space and allows us to provide our customers with the kind of quality and supply chain transparency they need. We are pleased that our efficiency in integrating Research Organics capabilities with existing SAFC technologies has brought our customers a substantially increased PharmaGrade materials portfolio in a very short period of time."
SAFC, the custom manufacturing and services business unit of Sigma-Aldrich Corporation, is recognized as a top 10 global specialty chemicals and biologics supplier.
Sigma-Aldrich is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology SAFC manufacturing.