White panel
 
history

History

Headquartered in Bangor, Pennsylvania, BioSpectra has a recognized company vision to provide the most trusted and reliable source for life science intermediates. Launched in 1994, the company has evolved from developing and manufacturing the first-ever Quality System Compliant versions of key biological buffers, to providing Zwitterionic buffers, amino acids, carbohydrates, custom solutions, excipients and active pharmaceutical ingredients. BioSpectra values the quality partnerships it forms with customers, to identify and exceed expectations for requirements.


By 1996, BioSpectra began manufacturing cGMP compliant, traceable, supply-chain-managed versions of Guanidine Hydrochloride, Urea and Ammonium Sulfate. Customers valued the reliability, safety and traceability of our products, and requested the additions of Tromethamine and Tris Hydrochloride to the BioSpectra portfolio. To this day, BioSpectra is the only FDA registered cGMP compliant, supply-chain-managed US manufacturer of Tromethamine and Tris Hydrochloride. Simultaneously, the company is the leading producer of cGMP Guanidine Hydrochloride, Urea, HEPES, MOPS and MES.


After five years of continued growth and validated scale-ups, BioSpectra responded to increased customer demand, acquiring a plant in Stroudsburg, PA. This move enabled an increase in batch capacity from 200-500kg to 3,000kg. By 2007, the company’s drive for the highest available purity and repeatability lead to the design, installation and validation of the first cGMP-compliant continuous process for the manufacturing of excipients. This continuous process still produces custom batch sizes validated up to 24,000kg. In 2011, a second facility in Bangor, PA., was acquired. With this second facility, BioSpectra’s operational footprint increased to over 175,000 sq.ft., spanning more than 40 acres in Pennsylvania.

Today, having redefined the standard for compliance and traceability, BioSpectra leads the industry in biological buffer production. As the company’s product offering continues to progress, meeting customer needs remains paramount. This is evident by the most recent product line additions, amino acids and carbohydrates.


As the manufacturer of the safest, purest and most traceable versions of excipients, active pharmaceutical ingredients and process chemicals we support and partner with the finest drug manufacturers in the world.