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The active pharmaceutical ingredient and excipient provider has expanded its parenteral ingredient manufacturing capacity and lab services.
BioSpectra announced that it has expanded its capacity for the synthesis and purification of active pharmaceutical ingredients (APIs) and excipients with low bioburden and low endotoxin (LBLE) requirements in an April 4, 2018 press release.
These products, intended for use in parenteral drug applications, are manufactured using the company’s manufacturing and purification systems, stringent environmental controls, strict process monitoring, robust quality and compliance programs, and comprehensive finished-product testing.
Product offerings, all of which are manufactured at BioSpectrea’s facilties in Bangor and Stroudsburg PA, include additional APIs and excipients being manufactured under proprietary contract agreements, LBLE excipients galactose, sucrose, and trehalose as well as GMP-compliant bulk biological buffers, process chemicals, and compounded solvents and solutions.
The additional APIs and excipients will be among the products launched in 2018 and added to the existing line.
BioSpectra has also expanded its quality control contract lab services portfolio to include inductively coupled plasma mass spectrometry analysis of elemental impurities required under United States PharmacopeiaGeneral Chapters <232> and <233> for all APIs and excipients for independent customer requests.
This additional capability is complemented by the company’s original offerings of internal raw material and finished product testing. Other lab services are also being made available on an independent, contractual basis, according to BioSpectra.