BIOSPECTRA, US Bulk BioPharm Manufacturing Division

Company Description

Industry Service Provider

BioSpectra’s Bulk BioPharm Manufacturing Division has been setting the quality standard as a manufacturer of biological buffers since 1995.  Our core product line includes US manufactured Tromethamine, Tris Hydrochloride, Urea, Guanidine Hydrochloride, HEPES, MES and MOPS..

Our Bulk products are manufactured in batches ranging from 50kg to 24,000kg for crystalline materials and 500L to 20,000L for liquid materials.

We offer customized compliance and specifications ranging from current industry standards to the ICH Q7A, FDA inspected, cGMP compliant systems designed by BioSpectra to provide you with the greatest regulatory assurance available today.

Our Bulk BioPharm Manufacturing Division is a contract manufacturer to the world’s leading providers of Biological Buffers.  Our fully integrated, on-site process development team can have your buffer or product designed, validated and commercially available in weeks-to-months, not months-to-years.  Each contract manufacturing relationship is personally managed by our leadership team providing you the attention and focus your product deserves.

Chemical Services Directory

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Capabilities/Services Directory

  • Analytical Services
  • Biological Purifications
  • cGMP Recrystallizations
  • cGMP Solution Manufacturing
  • cGMP Solvent Recrystallizations
  • Packaging
  • Substitution Chemistry
  • Transportation
  • Warehousing
  • Certification
  • Analytical Capabilities and Equipment: Acid base titration in aqueous media; Atomic Absorption Spectroscopy; Metals Testing: Iron, Lead, Copper, Calcium, Magnesium, Arsenic, Sodium; Dnase; Endotoxin; IR Spectroscopy; Melting Ranges; Moisture balance; pH; Protease; Residue on Ignition; Rnase; USP, EP/BP; UV Spectroscopy; Wet Chemistry Analysis
  • Packaging Options Offered: Bottles, Pails, Cubetainers, Drums, Carboys, Totes, Tank trucks, Isotainers
  • Warehousing/Storage Capabilities: Enclosed warehousing, Temperature controlled, Humidity controlled, Push back racking
  • Transportation Modes Available: Truck, Sea, Air, Courrier
  • Management Services: Finance, Information Technology, Human Resources, Environmental, Health and Safety, Purchasing and Supplier Relationship Management

Industries / Markets Served

  • Batch, Custom and Specialty Chemical Industry
  • Biochemicals
  • Biopharmaceutical
  • Biotechnology
  • Education
  • Life Sciences
  • Nutraceutical
  • Performance Chemicals
  • Pharmaceutical
  • Research
  • Specialty Chemicals

Consultants/Service Providers

  • Analytical/Testing Services
  • Sourcing

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