A BioSpectra partnership provides the assurance that each Contract Manufactured product satisfies customer needs, and is manufactured with the required compliance. BioSpectra has the capability to deliver Contract Manufactured products, by partnering with customers on the following criteria:
- Specifications – customer-provided or BioSpectra-developed
- Requested Batch Size
- Versatile Packaging Options
- Fast delivery of finished products
Every Contract Manufactured product is manufactured, packaged, tested and approved in BioSpectra’s secure facilities, ensuring contamination-free, traceable and reliable materials.
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High Purity Crystalline Compounds
BioSpectra’s extensive line of manufacturing suites, qualified equipment and advanced quality systems generate pharmaceutical targeted versions of materials using recrystallization methods, acid/base reactions and substitution chemistry.
Custom solutions at BioSpectra are formulated in accordance to customer requests and industry demand. BioSpectra custom solutions are produced in clean, compliant environments and can be sterile filtered into final packaging.
BioSpectra’s capabilities range from simple to complex solutions, which are supplied in concentrations ranging from milliMolar (mM) solutions to percent (%) solution characterizations. Our solution manufacturing experience includes:
- pH buffers
- HPLC mobile phase buffers
- Zwitterionic buffers
The BioSpectra Process Development Team has more than 20 years’ experience designing purification systems based on process parameters that achieve the correct critical quality characteristics of the end product. An extensive range of manufacturing equipment offers a secure and readily available manufacturing site for product, from sampling through bulk commercialization.
Managing flow characteristics and dissolution requires consistent and defined crystals. BioSpectra uses the best available technology to manipulate crystals to meet customers’ processing parameters. Current equipment includes our 316 S/S Fitz-Mill™, 316 S/S hammer mill, 316 S/S 30 ft3 rotary blender and 316 S/S air sieve.