Contract GMP Manufacturing Product Inquiry
Exclusively Manufactured in the USA
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
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
- 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
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
