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Corporate Profile

What We Do


BioSpectra manufactures cGMP fine chemicals for use in pharmaceutical processes as well as finished drug products used by global BioPharma, Bio-CMOs and Biochemical companies. This includes cGMP bulk biological buffers, cGMP large volume bio-buffer solutions, cGMP process fine chemicals, cGMP chlorinated amino acids, highly purified parenteral grade carbohydrates and carbohydrate (Dextran) polymers, as well as other novel and compendial excipients. 

 

Who We Are

 

  • BioSpectra is and end-to-end producer of raw materials and manufacturer of the highest purity cGMP fine chemicals for biopharmaceutical applications.

  • We control, own and operate the production and quality of over 95% of all chemical raw materials used to make our finished cGMP products.

  • Our base of cGMP manufacturing is at our FDA registered, cGMP facilities in Bangor and Stroudsburg, PA, USA.

  • We can offer long-term fixed pricing to shield against fluctuations.

  • We are absolutely the best at supporting new qualifications via documentation, samples, and audits. 

 

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Corporate Overview
GMP Product Categories
  • GMP Process Chemicals
  • Bulk Custom Solutions
  • Bulk Biological Buffers
  • Functional Expedients
  • Active Ingredients
Comprehensive Quality & Regulatory System
  • FDA Registered & Inspected
  • Full Transparency in Documentation
  • Stringent Quality Program & Controls
  • Document Support – DMF Submissions
  • Rigorous compliance to Global Standards
  • FDA & ICH Q7 Guidance for Drug Substances
  • Global GMP Requirements – US, IPEC, ICH Q7
  • State-of-the-art Instrumentation & Laboratories
  • Culture of Embracing Evolving Regulatory Demands
GMP Custom Services
  • GMP Product Development
  • Small Molecule Custom Synthesis
  • Purification of Excipients
  • Scale-Up, Bench to Bulk
  • Regulatory (Product) Support
Corporate Values & Commitments
  • True GMP Product Claim – Always Synthesized and/or Purified not simply tested and repackaged
  • Reliable, Consistent, Uniform, Quality-Based Manufacturing of Premium Pharmaceutical Ingredients
  • Authentic, Secure Supply Chain - 100% Traceable Raw Materials from Qualified Sources
  • Fully Validated GMP Manufacturing Systems & Qualified Equipment

Organizational Profile

BioSpectra facilities consist of approximately 343,000 square feet across over 52 acres. BSI staff consists of over 200 employees.

MAJESTIC PHARMACEUTICAL INGREDIENT MANUFACTURING:

100 Majestic Way, Bangor, PA 18013 Approx. 150,000 square feet

JACOBSBURG CORPORATE SERVICES CENTER:

1349 Jacobsburg Road, Wind Gap, PA 18091 Approx. 25,000 square feet

ROCKDALE BIOLOGICAL BUFFER MANUFACTURING:

1474 Rockdale Lane, Stroudsburg, PA 18360 Approx. 35,000 square feet

MCCONNELL SUPPLY CHAIN CENTER:

51 N 3rd Street, Stroudsburg, PA 18360 Approx. 60,000 square feet

COMSTOCK BIOSPECTRA CANADA D.B.A. DEXTRAN PRODUCTS:

421 Comstock Road, Scarborough, ON MIL2H5, Canada Approx. 25,000 square feet

FULMER BIOBUFFER SOLUTIONS LAB & WAREHOUSE:

51 N 3rd Street, Stroudsburg, PA 18360 Approx. 80,000 square feet