BioSpectra is a FDA-registered, cGMP compliant manufacturer and commercial producer of biological buffers, pharmaceutical excipients and Active Pharmaceutical ingredients.
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.
The Excipients offered by BioSpectra are produced in accordance with cGMP guidelines to provide the highest quality materials available to the biopharmaceutical industry.
BioSpectra’s Active Pharmaceutical Ingredients are US manufactured in our FDA Registered facility located in Bangor, Pennsylvania. Our APIs are manufactured in accordance with ICH Q7 guidelines using qualified equipment and utilities within validated processes and come with a traceable supply chain.
BioSpectra’s Contract Manufacturing Program supports custom product opportunities through confidential partnerships and agreements. Our fully integrated Process Development team can have your proprietary Solution, Reagent, Bulk Fine Chemical, Excipient or API product designed, validated and commercially available to meet your needs. Each contract manufacturing relationship is personally managed by our leadership team to provide the attention and focus you and your product deserve.