Exclusively Manufactured in the USA
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BioSpectra offers a range of Custom
GMP Contract Products & Services
manufactured exclusively in our
state-of-the-art, FDA registered
and inspected GMP facility
in Bangor PA, USA.

BioSpectra operates under a stringent Quality Program rigorously adhering to US GMP, IPEC and ICHQ7 guidelines for the manufacture of all custom products
Custom GMP Categories
  • Unique GMP Compounded Solvents & Solutions
  • API Development & Manufacturing
  • Small Molecule Custom Synthesis
  • Full GMP Product Development
  • Purification of Key Ingredients
  • Drug Master File Submissions
  • Pilot Scale Up
  • Lab Services
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Custom GMP Manufacturing
  • SYNTHESIS: APIs & other Key Ingredients / Organic and Inorganic molecules and salts / Corrosive molecules / Chlorides Chlorinations / Ionic Substitution / Small volume support with Scale 1-1000 kg lots / Solvent, Alcohol & Aqueous based
  • LIQUID CHEMISTRY: UNIQUE GMP COMPOUNDED
    SOLVENTS & SOLUTIONS:
    Acid-Base/ Solvent & Alcohol Based/ pH, Zwitterionic Buffers / Hazardous Blends and Compounds / Various Concentration Ranges / 10 liter to 24,000 liter batch volumes
  • PURIFICATION: Crystallization / Low Micron Filtration / Ion Removal / trace metal reduction / Low Bioburden Low Endotoxin demands / Alcohol, Aqueous & Solvent base
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  • CUSTOM TESTING, LABELING & PACKAGING:
    Per Customer Request
  • SCALE-UP: Bench to Bulk – We offer turnkey services for product and process development with the ability to scaleup from lab to pilot batches to bulk production all in one facility under one Quality & Regulatory system
  • PARTICLE CHARACTERISTICS: Various milling and particle manipulation techniques to achieve consistent and defined crystal size according to customer requirements – Jet Milling / Blending / Rotary, Fluid Bed, spray and Tray drying
  • GMP COMPLIANCE SUPPORT: Up to and including DMF Type II and Type IV submissions
Support Package
Process Development – Manufacture of Validation Batches – Ongoing Support
Analytical Support Development
  • Analytical Method Validation
  • Transfer of Analytical Methods
  • Custom Analytical Methods and Specifications
  • Bioburden and Endotoxin Testing as Needed
  • Complete Impurity Profile as Requested
  • Elemental Impurities
  • Residual Solvents
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Development Support
  • Stability Study
  • Custom GMP Services as needed
  • Custom Labeling and Packaging
  • Manufacture of Validation Batches
  • Drug Master File submission as Requested
  • Efficient Development Timeline
  • High-touch management of your project
Ongoing Support
  • Commercial Manufacturing
  • On Site Audits
  • Annual Product Review
  • Management of Change
  • Post Submission Change Notification
  • Full support through the life of your product
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