Our History

Early in 1994 our founder began visiting biotech companies in an effort to understand raw material applications as they related to quality compliance. He immediately realized that repackaging fertilizer and industrial chemicals to sell as biological buffers was unsafe for the end-dose customers. Later that same year, after extensive research, the lab that was used to develop our processes was opened in Shawnee-on-Delaware, PA. From that time we have devoted our business lives to offering the best options for safe and compliant biological buffers.

After the lab’s inception in December of 1994, more than 400 experimental batches were painstakingly completed with extensive documentation and our current processes were developed. In September of 1995, BioSpectra was officially incorporated in the State of Pennsylvania. In March of 1996 we opened our first manufacturing facility in Sciota, PA. This facility became the site of the first cGMP manufactured Urea, Tromethamine, Tromethamine Hydrochloride, Guanidine Hydrochloride, Ammonium Sulfate, and Guanidine Thiocyanate.

As a result of our continual drive to maintain the highest level of compliance where none had previously existed and recognizing the approach of Q7A, we aligned our entire quality system in early 2001 with that new standard of compliance. Before most of the industry had even heard of the approval of these new guidelines, our entire quality system had been reformatted and restructured to comply with the coding and intent of Q7A. BioSpectra had again led by example to create the new standard in compliance for buffer manufacturing.

In order to meet demand, we opened our next facility in Stroudsburg, PA in December of 2000. Over the next three years we moved our validated processes to this site in new, industry leading, dedicated manufacturing cells (suites) with the best available technology.

From our first day of operation, BioSpectra has proudly used 100% dedicated equipment to manufacture its biological buffers. Our original 200-gallon batches of material in plastic tanks were made at levels of compliance no one else has managed to reach even today for cGMP manufactured biological buffers. Eventually these manufacturing lines moved to 400-gallon, then 800-gallon batches before reaching the capacity we have at present, including, a three million kilogram fully-enclosed, continuous process manufacturing line.

Our relationships with the leaders in biopharmaceutical drug manufacturing have been the inspiration for every step of progress that we have made. We value our business partnerships with the producers of the safest and most compliant chemistry around the world and look forward to new, yet to be discovered improvements in the years ahead.