SAFC, a custom manufacturing and services business unit of Sigma-Aldrich, has expanded its portfolio of PharmaGrade raw materials which are used for manufacturing biopharmaceuticals.
The portfolio, in addition to 25 new raw materials, comprises 65 high-quality buffers, amino acids and specialty chemicals.
The PharmaGrade products are documented with the production history that provide details on consistent and controlled processes compliant with GMP or SAFC 'Elite' grade documentation guidelines.
In addition to the production history, the product portfolio features formal manufacturer qualification, quality assurance review and release of every lot, change control notification, as well as quality and regulatory support documentation.
SAFC marketing and research development vice president Deborah Slagle said, "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."
