Biospectra manufactures high purity biological buffers specifically intended for use in biopharm applications.
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 realised that repackaging fertilisers and industrial chemicals to sell as biological buffers was unsafe for the end dose user. Later that same year, after extensive research, the lab that was used to develop our processes was opened. From that time, we have devoted our business lives to offering the best options for safe and compliant biological buffers.
As a result of our continual drive to maintain the highest level of compliance where none had existed before, and recognising 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. Our current product line, consisting of Urea, Tromethamine (Tris), Tris Hydrochloride, and Guanidine Hydrochloride (crystal and solution), are produced under strict cGMP guidelines in fully dedicated equipment.
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. At BioSpectra, every batch of material is manufactured from a process designed, built, and validated for one purpose – to make material suitable for use in biopharm applications.
BioSpectra is proud that our buffers exceed the highest quality chemistry available. Every batch of material we offer is a result of years of experience in the industry, the best systems in the industry, fully-dedicated, custom designed processes which utilise equipment specifically installed for each product, and the finest team ever assembled for compliant buffer manufacturing. Our team at Biospectra makes cGMP compliant buffers. That’s all we do, no exceptions.
What sets BioSpectra apart is that we provide real chemistry for real biopharmaceutical applications. We ensure real compliance for the end-dose customer, always making their chemistry our number one concern. BioSpectra offers 100% cGMP compliant material specifically manufactured for bioprocessing from its entire product line, and we personally hold ourselves 100% accountable to the end dose user.
BioSpectra offers a staff of fully trained personnel serving only the biopharmaceutical intermediate needs. This allows us to be audit ready at absolutely any time, giving our customers peace of mind. This is why we provide the very best business partnerships. We have the most experience in working exclusively with the biopharm industry. We have produced more than 2,000 batches of material going into hundreds of biopharm formulations. We have worked with the leading professionals in the industry to offer resolutions of nearly every kind. Most importantly, we will find the version, configuration, package, purity, delivery and combination of our products to best suit our customer’s needs.
BioSpectra guarantees real integrity. 100% compliance, 100% real chemistry, 100% qualified staff, and 100% dedicated to serving the biopharm industry.
RR2 Box 2129G
Stroudsburg, PA 18360