As a contract research and breakthrough organization (CRDO), Boston academy of Biotechnology, LLC, provides full spectrum services for microbial fermentation and mammalian cell culture processes. From difficult late exploration stage, to preclinical and also all the way through come commercialization, our specialization in QbD v the incorporation of following generation technologies has helped drug advance organizations successfully bring over 15 assets to market.
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Boston academy of Biotechnology, llc (BIB) rectal a facility which has isolated labs for cell culture, fermentation, purification and also analytical services.
Manufacturing scalability have the right to save 10s of millions of dollars upon commercialization. Process Characterization in depth studies provide the instrument to accelerate FDA approvals and also scale mfg by giving granular level reporting of every stages that impurity removals, finish identification of power parameters, procedure inputs influence outputs etc. Generally carried out in so late Phase 2/early phase 3, inquire around this company today
Understanding the certain environmental conditions that destabilize her protein is the goal of pre-formulation studies. These studies are designed come learn about the protein"s susceptibility come a range of appropriate stresses, recognize potential destruction pathways the the product. Based upon results, then build a baseline biophysical profile.
Common eco-friendly variations are
• pH• Temperature• Ionic strength• Stress• Freeze-thaw cycles
Protein characterization work-related ensures the identity, purity, structural and also conformational verity and activity of an attention protein. We perform a variety of routine protein analyses throughout all job stages. If needed, we have the right to submit your samples for extr methods of characterization. We also offer specialized protein characterization solutions for purified proteins.
Routine assays because that Protein characterization:
• Size exclusion chromatography• Ion exchange chromatography• gelatin electrophoresis through purity analysis by densitometer• UV-Vis spectrophotometer• west blot that identity• ELISA because that activity• others
Following ICH guideline, us offer irreversible and increased studies for intermediates, medicine substance, medicine product and also placebo. Us also carry out freeze-thaw examine for purified medicine substance.
We likewise provide process step hold study, i m sorry will carry out stability details for any process intermediate to help procedure development.
Available warehouse temperature
• 37℃• 4℃• -20℃• -80℃
Boston academy of Biotechnology develops, qualifies product-specific analytical methods to support customers’ manufacturing processes, and also meets any research and regulatory requirements. Our knowledgeable staff deserve to use developed technique in rotate for helping process development, optimization and procedure trouble-shootingDeveloping assays incorporate testing for product purity and also titer, product/process connected impurities, relax & in-process assays in support of microbial fermentation, cell society and purification development:
• Protein assay (BCA, Bradford, A280)• UV-Visible• Electrophoresis (SDS-PAGE, IEF, Blot)• color layer analyzer (affinity, RP, IEX, HIC, SEC)• Immuno-assay ( ELISA, HCP)• LAL Endotoxin assays• Bioburden determination
From DNA come clone choice and stability, BIB can carry out strain & cabinet line development work based upon the considerable working endure with different types of mammalian cabinet lines, as well as micro-organisms such as E. Coli and also Pichia pastoris, Saccharomyces, and Bacillus subtilis.
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• We market the business of design with open sources technology to mitigate royalty burden intellectual Property.• We provide an integrated stable high expression cabinet lines (strains) breakthrough solution to simplify the workflow and accelerate procedure development to commercial manufacture.• us engineer selected strains (cell lines) to fulfill our customers’ individual requirements in their difficult industrial environments
We have experience v microbial fermentation and also mammalian cell society from lab scale to manufacture scale (e.g., 10mL minibioreactor , 2000L functional bioreactor because that mammalian cabinet culture, and also industrial fermentor approximately 500 m3).We can help you transfer, scale-up or scale-down the arisen bioprocess to fulfill your demands of commercial production. We have the right to also aid you troubleshoot any process related problems no issue the process is in R&D or manufacturing stage.