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
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BioSpectra is and end-to-end producer of raw materials and manufacturer of the highest purity cGMP fine chemicals for biopharmaceutical applications.
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Our base of cGMP manufacturing is at our FDA registered, cGMP facilities in Bangor and Stroudsburg, PA, USA.
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We can offer long-term fixed pricing to shield against fluctuations.
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We are absolutely the best at supporting new qualifications via documentation, samples, and audits.
For further information, please contact Paul Dimarco at paul.dimarco@biospectra.us.
- GMP Process Chemicals
- Bulk Custom Solutions
- Bulk Biological Buffers
- Functional Expedients
- Active Ingredients
- 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 Product Development
- Small Molecule Custom Synthesis
- Purification of Excipients
- Scale-Up, Bench to Bulk
- Regulatory (Product) Support
- 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
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. 30,000 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