BioSpectra  

Bangor,  PA 
United States
https://www.biospectra.us/
  • Booth: 625

BioSpectra manufactures premium, GMP Pharmaceutical Ingredients exclusively in the USA: APIs / Excipients / GMP Process Chemicals & Solutions / High Purity, GMP, Bulk Biological Buffers & Denaturants / GMP Contract Manufacturing of APIs, Excipients & Process Chemicals.

FDA Registered and Inspected, ICHQ7, IPEC & US-GMP Compliant. 175,000 square feet of state-of-the-art GMP manufacturing and storage facilities.

We focus on solving ingredient issues through custom synthesis, purification and GMP product development.

Our goal is to become a valued partner in your secure supply chain and the solution to key ingredient issues you may have.


 Videos

BioSpectra Active Pharmaceutical Ingredients

 Press Releases

  • BioSpectra Announces Expansion of Parenteral Ingredient Manufacturing Capacity

    BioSpectra has expanded its capacity for the synthesis and purification of APIs and Excipients with Low Bioburden and Low Endotoxin (LBLE) requirements.  These products are intended for further use in Parenteral Drug Applications and are manufactured with demanding specifications utilizing BioSpectra’s advanced manufacturing and purification systems, stringent environmental controls, strict process monitoring, robust quality and compliance programs and comprehensive finished product testing.  The intended product offering includes LBLE Excipients: Galactose, Sucrose and Trehalose. 

    Additional APIs and Excipients are being manufactured under proprietary contract agreements and will be among the products launched this year and added to the existing line.  US FDA registered and inspected, BioSpectra exclusively manufactures all its products at state-of-the-art GMP facilities in Bangor and Stroudsburg PA, USA. Products include premium APIs, Excipients, GMP Bulk Biological Buffers, GMP Process Chemicals, and unique GMP Compounded Solvents and Solutions.  In addition, BioSpectra offers a range of contract, custom GMP manufacturing services and Lab support. 

    For more information our team of specialists can be found at Booth #625.

  • BioSpectra has expanded its Quality Control contract lab services portfolio to include ICP-MS analysis of elemental impurities for independent customer requests.

    BioSpectra's Quality Control Lab Services continues to expand beyond its original role of supporting internal raw material and finished product testing to include independent customer requests. A focal point is ICP-MS analysis of elemental impurities required under USP General Chapters <232> and <233> for all APIs and Excipients. BioSpectra’s expanded Quality Control staff has received extensive training in the validation, testing and application of the USP General Chapters and ICH Q3 Guidelines. Other lab services are also being made available on an independent, contractual basis.

     

    FDA registered and inspected, BioSpectra exclusively manufactures all its products at its state-of-the-art GMP facilities in the USA. Products include premium APIs, Excipients, GMP Bulk Biological Buffers, GMP Process Chemicals, and unique GMP Compounded Solvents and Solutions.

    For more information our team of specialists can be found at CPhI Philadelphia, April 24-26th, Booth #625. Call or contact us for an appointment today or just stop by to learn more!


 Products

  • Contract manufacturing services
    BioSpectra offers a wide range of products, which includes contract manufacturing services....

  • Contact us for more information.
  • Galactose
    Galactose is a Critical Excipient for Parenteral Applications....

  • Grade available

    -Low BioBurden, Low Endotoxin

  • Guanidine Hydrochloride
    BioSpectra offers a wide range of products, which includes guanidine hydrochloride. Features: it is a strong protein denaturant that functions as a chaotropic agent....

  • Grades available

    Bio Pharma Grade -GMP Process Grade

    Bio Excipient Grade

    Low Bioburden, Low Endotoxin

  • Guanidine Thiocyanate
    BioSpectra offers a wide range of products, which includes guanidine thiocyanate. Features: it is a chaotropic agent....

  • Grades available

    Bio Pharma- GMP Process Grade

    Bio Excipient

    Low Bioburden, Low Endotoxin

  • HEPES Free Acid
    BioSpectra offers a wide range of products, which includes HEPES, free acid. Features: it is a zwitterionic buffer used to maintain pH of media used in cell cultures....

  • Grades available

    Bio Pharma Grade- GMP Process Chemical 

    Bio Excipient Grade 

  • L-Cystine Dihydrochloride
    Grade available

    Bio Excipient...

  • Please contact us or stop by booth #625 for more information.
  • MES monohydrate
    BioSpectra offers a wide range of products which includes MES, monohydrate. Features: it is a zwitterionic buffer that is not absorbed through cell membranes and is virtually transparent in UV light....

  • Grades available

    Bio Pharma Grade- GMP Process Chemical

    Bio Excipient Grade 

  • MOPS, Free acid
    BioSpectra offers a wide range of products, which includes mops, free acid. Features: it is a zwitterionic buffer used as a running buffer for denaturing gel electrophoresis and as a buffering agent in many biological and biochemical applications....

  • Grades available

    Bio Pharma Grade- GMP Process Chemical

    Bio Excipient Grade 

  • Potassium Bromide
    In microbiology, Potassium bromide may be used for the removal of peripheral membrane proteins and in the centrifugation and separation of lipoproteins in high density solvents....

  • Grades available

    Bio Active Grade 

  • Sodium Hydroxide 10N <5 ppm Cl
    Grade available

    Bio Pharma- GMP Process Grade...

  • Please contact us or stop by booth #625 for more information.
  • Sucrose
    Grade available

    Low Bioburden, Low Endotoxin...

  • Please contact us or stop by booth #625 for more information.
  • Trehalose
    Grade available

    Low Bioburden, Low Endotoxin...

  • Please contact us or stop by booth #625 for more information.
  • Tris/ Tromethamine
    BioSpectra offers a wide range of products, which includes Tris / Tromethamine. Features: it is commonly used as a buffer in biochemistry and molecular biology, stabilizes the pH of solutions in electrophoresis and other biological applications....

  • Grades available

    Bio Pharma Grade- GMP Process Chemical

    Bio Excipient Grade

    Bio Active Grade

    Low Bioburden, Low Endotoxin

  • Tris HCl
    BioSpectra offers a wide range of products, which includes Tris hydrochloride. Features: it is used to adjust and stabilize the pH ranges for gels used in electrophoresis applications....

  • Grades available

    Bio Pharma Grade- GMP Process Chemical

    Bio Excipient Grade

    Low Bioburden, Low Endotoxin

  • Uracil
    Grade available

    Bio Pharma Grade- GMP Process Chemical...

  • Please contact us or stop by booth #625 for more information.
  • Urea
    Urea is used in biochemistry and molecular biology as a protein denaturant with low UV-absorptivity....

  • Grades available

    Bio Pharma Grade- GMP Process Chemical 

    Bio Excipient Grade 

    Bio Active Grade 

    Low Bioburden, Low Endotoxin