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Biospectra

High Purity Biological Buffers

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Biospectra

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.

Buffer manufacturing

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.

Material specifically manufactured for bioprocessing

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.

Biopharm formulations

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.

Biospectra
RR2 Box 2129G
Rockdale Lane
Stroudsburg, PA 18360

Tel: +1 (570)-476-2710
Fax: +1 (570)-476-7959
Sales Contact: The Sales Department
sales@biospectra.us
www.biospectra.us

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Ammonium Sulfate

Other chemical names for Ammonium Sulfate are Diammonium sulfate; sulfuric acid, diammonium salt; Actamaster; Dolamin; mascagnite. This product is used as an intermediate to precipitate and fractionate proteins.

Ammonium Sulfate assists in the purification of biochemical products. It can also be used as a fertilizer and as a flame retardant. The Ammonium Sulfate manufactured at BioSpectra is fully validated following cGMP guidelines and meets all FCC and ACS specifications.

Guanidine HCl

Guanidine HCl is a white crystalline powder that is used as a denaturant to unfold proteins and turn them into their original polypeptide chains. It is commonly used in the isolation of RNA by dissociating the RNA into its nucleic acids and protein forms.

At BioSpectra, Guanidine HCl is manufactured using a validated process following cGMP guidelines. All equipment used in the manufacture of Guanidine HCl is dedicated to that process to ensure the highest quality and purity. All raw materials used in the Guanidine HCl process are received through an extensive supplier approval program and are tested for…

MOPS

The chemical name of MOPS is 3-(N-morpholino)propanesulfonic acid. MOPS is a Zwitterionic buffer used as a running buffer for denaturing gel electrophoresis.

MOPS is a buffering agent used in many biological and biochemical applications. This free acid buffer is useful in maintaining pH levels and enzymatic activities. The MOPS manufactured at BioSpectra is fully validated following cGMP guidelines and is tested against designated specifications to ensure the highest purity.Approved chemical synonyms for MOPS:3-(N-Morpholino)propanesulphonic acid (MOPS)3-(n-Morpholino)propanesulphonic Acid3-Morpholinopropanesulphonic AcidMops(3-(morpholino)propanesulphonic…

Tris Hydrochloride

Tris HCl is a white crystalline powder used in the biopharmaceutical industry. Tris HCl is used as a stabilising buffer in biological applications such as electro chromatography, UV analysis and HPLC.

Tris HCl is also utilised to adjust pH ranges for gels used in electrophoresis applications. At BioSpectra, Tris HCl is manufactured in a validated process following cGMP guidelines. All equipment used in the manufacture of Tris HCl is dedicated to that process to ensure the highest quality and purity. All raw materials used in the…

Tromethamine

Tris is a white crystalline powder used in the biopharmaceutical industry. Tris is commonly used as a buffer in biochemistry and molecular biology to stabilise the pH of solutions in electrophoresis or other biological applications.

Tris is also an enzyme inhibitor for use in the biopharmaceutical industry and is commonly utilised in electro chromatography, UV analysis and HPLC applications. At BioSpectra, Tris is manufactured in a validated process following cGMP guidelines. All equipment used in the manufacture of Tris is dedicated to that process to ensure the highest quality and…

Urea

Urea is a white crystalline powder used in the biopharmaceutical industry. Urea is commonly used in denaturing and solubilising proteins.

As a chaotropic agent, it is used to restructure proteins. In certain cases where proteins are denatured, Urea may also be useful in re-naturing these proteins. At BioSpectra, Urea is manufactured in a continuous process which has been validated following cGMP guidelines. All equipment used in the manufacture of Urea is dedicated to that process…
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