BioSpectra Offers Industry-Leading Custom Manufacturing Capabilities
BioSpectra, Inc. recently announced its ability to offer contract manufactured products for pharmaceutical, biopharmaceutical, and drug manufacturing markets direct from its newly opened FDA-registered facility in Bangor, PA. Using its R&D and technology expertise, and ICHQ7 manufacturing systems, BioSpectra provides custom cGMP purifications, acidifications, acid/base reactions, custom formulations, and particle manipulation backed by fully documented regulatory support.
“BioSpectra is proud of its customer-focused, custom manufacturing capabilities, which provide a unique combination of industry-leading quality – from process chemistry through finished end product – with documented regulatory support for each end use being the basis of that design,” said Richard Mutchler, President of BioSpectra. “Our clients rest assured knowing they are working with a partner who offers written, declared end-use statements detailing the product is designed, engineered, validated, and manufactured solely for the purpose it’s being used. Therefore, we confirm in advance the strict controls with which BioSpectra governs its equipment, processes, and products.”
In addition to its exceptional level of quality and regulatory support, BioSpectra’s custom manufacturing capabilities provide customers with cost-efficient, time-sensitive, and validated life science intermediates for end formulation. Acknowledging that the cost of poor quality far exceeds the up-front cost to achieve consistent performance of the highest quality, BioSpectra saves customers the time, manpower, and investment required for their in-house R&D, process development, and analytical support. Instead, they can rely on BioSpectra to design a product according to their predetermined specifications.
BioSpectra is an FDA-registered cGMP-compliant, contract manufacturer and commercial producer of biological buffers, pharmaceutical excipients, and laboratory reagents. BioSpectra manufactures pH-stabilizing biological buffers for the biopharmaceutical industry in its state-of-the-art Pennsylvania facilities. These biological buffers offer low UV absorptivity, minimal reactivity, stable pH, and high solubility in water for use in various biological applications. Excipients offered by BioSpectra’s Bulk BioPharm Manufacturing Division are produced in accordance with cGMP guidelines to provide the highest quality materials available to the biopharmaceutical industry. BioSpectra’s line of laboratory reagents is offered through its Laboratory Products and Services Division. Stringent product testing of each reagent ensures that our customers receive only the highest quality material for use in their various laboratory applications. For more information, visit www.BioSpectra.us or PR Contact: Anthony Galasso, 3E Public Relations, 973.263.5296, agalasso@3epr.com.
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