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Boston Institute of Biotechnology

Southborough, Massachusetts, US

As a contract research and development organization (CRDO), Boston Institute of Biotechnology, LLC, provides full spectrum services for microbial fermentation and mammalian cell culture processes. From challenging late discovery stage, to preclinical and all the way through to commercialization, our expertise in QbD with the incorporation of next generation technologies has helped drug development organizations successfully bring over 15 products to market.

Boston Institute of Biotechnology, LLC (BIB) occupies a facility which includes isolated labs for cell culture, fermentation, purification and analytical services.

Visit our website at bostonbib.com for additional information. Reach out through Science Exchange and/or contact Michael Osborne at [email protected] today for a quote on your next project.

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ICH Stability Testing
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Biopharmaceutical Manufacturing
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Peptide Manufacturing
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Bioprocess Development and Scale-Up
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Manufacturing scalability can save tens of millions of dollars upon commercialization. Process Characterization in depth studies provide the mechanisms to accelerate FDA approvals and scale mfg by providing granular level reporting of all stages of impurity removals, complete identification of performance parameters, process... Show more »

Manufacturing scalability can save tens of millions of dollars upon commercialization. Process Characterization in depth studies provide the mechanisms to accelerate FDA approvals and scale mfg by providing granular level reporting of all stages of impurity removals, complete identification of performance parameters, process inputs affecting outputs etc. Generally conducted in late Phase 2/early Phase 3, inquire about this service today

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DNA/RNA Analysis and Quality Control
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HPLC Method Development
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HPLC/FPLC Method Development

HPLC/FPLC Method Development

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Drug Preformulation
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Understanding the specific environmental conditions that destabilize your protein is the goal of pre-formulation studies. These studies are designed to learn about the protein's susceptibility to a variety of relevant stresses, determine potential degradation pathways of the product. Based on results, then develop a baseline... Show more »

Understanding the specific environmental conditions that destabilize your protein is the goal of pre-formulation studies. These studies are designed to learn about the protein's susceptibility to a variety of relevant stresses, determine potential degradation pathways of the product. Based on results, then develop a baseline biophysical profile.

Common environmental variations are

• pH
• Temperature
• Ionic strength
• Stress
• Freeze-thaw cycles

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Protein Characterization Services
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Protein characterization work ensures the identity, purity, structural and conformational integrity and activity of an interest protein. We perform a number of routine protein analyses throughout all project stages. If needed, we can submit your samples for additional methods of characterization. We also offer specialized protein... Show more »

Protein characterization work ensures the identity, purity, structural and conformational integrity and activity of an interest protein. We perform a number of routine protein analyses throughout all project stages. If needed, we can submit your samples for additional methods of characterization. We also offer specialized protein characterization services for purified proteins.

Routine assays for Protein characterization:

• Size exclusion chromatography
• Ion exchange chromatography
• Gel electrophoresis with purity analysis by densitometer
• UV-Vis spectrophotometer
• Western blot of identity
• ELISA for activity
• others

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Product Stability Testing
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Following ICH guideline, we offer long-term and accelerated studies for intermediates, drug substance, drug product and placebo. We also provide freeze-thaw study for purified drug substance.

We also provide process step hold study, which will provide stability information for any process intermediate to help process development.

Available storage temperature

• 37℃
• 4℃
• -20℃
• -80℃

Following ICH guideline, we offer long-term and accelerated studies for intermediates, drug substance, drug product and placebo. We also provide freeze-thaw study for purified drug substance.

We also provide process step hold study, which will provide stability information for any process intermediate to help process development.

Available storage temperature

• 37℃
• 4℃
• -20℃
• -80℃

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Analytical Method Development
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Boston institute of Biotechnology develops, qualifies product-specific analytical methods to support customers’ production processes, and meets any research and regulatory requirements. Our experienced staff can use developed method in turn for helping process development, optimization and process trouble-shooting
Developing... Show more »

Boston institute of Biotechnology develops, qualifies product-specific analytical methods to support customers’ production processes, and meets any research and regulatory requirements. Our experienced staff can use developed method in turn for helping process development, optimization and process trouble-shooting
Developing assays include testing for product purity and titer, product/process related impurities, release & in-process assays in support of microbial fermentation, cell culture and purification development:

• Protein assay (BCA, Bradford, A280)
• UV-Visible
• Electrophoresis (SDS-PAGE, IEF, Blot)
• Chromatography (affinity, RP, IEX, HIC, SEC)
• Immuno-assay ( ELISA, HCP)
• LAL Endotoxin assays
• Bioburden determination

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Stable Cell Line Generation
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From DNA to clone selection and stability, BIB can provide strain & cell line development work based on the extensive working experience with different types of mammalian cell lines, as well as micro-organisms such as E. coli and Pichia pastoris, Saccharomyces, and Bacillus subtilis.

• We offer the service of engineering... Show more »

From DNA to clone selection and stability, BIB can provide strain & cell line development work based on the extensive working experience with different types of mammalian cell lines, as well as micro-organisms such as E. coli and Pichia pastoris, Saccharomyces, and Bacillus subtilis.

• We offer the service of engineering with open sources technology to reduce royalty burden Intellectual Property.
• We provide an integrated stable high expression cell lines (strains) development solution to simplify the workflow and accelerate process development to commercial manufacture.
• We engineer selected strains (cell lines) to satisfy our customers’ individual requirements in their challenging industrial environments

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Mammalian Cell Culture
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Boston Institute of Biotechnology develops and runs reproducible, robust and scalable microbial fermentation and mammalian cell culture process for the production of therapeutic protein and antibodies. We have years of experience with fermentation and mammalian cell culture technologies to meet the future commercial requirement... Show more »

Boston Institute of Biotechnology develops and runs reproducible, robust and scalable microbial fermentation and mammalian cell culture process for the production of therapeutic protein and antibodies. We have years of experience with fermentation and mammalian cell culture technologies to meet the future commercial requirement such as high throughput process development technologies, disposable mini bioreactors, high cell density screening, and complex system optimization.
Our key equipment includes Applikon micro-Matrix, DASGIP® Benchtop Bioreactors, 50L Sartorius D30 Bioreactor, mass flow controllers for gas mixing, Terumo sterile tubing welder, biosafety cabinet, Nova Bioprofile 400 Analyzer, YSI, Innova 4330 shaker incubator and Infor HT Multitron shaker incubators, etc.

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Microbial Fermentation and Bioprocessing
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Boston Institute of Biotechnology develops and runs reproducible, robust and scalable microbial fermentation and mammalian cell culture process for the production of therapeutic protein and antibodies. We have years of experience with fermentation and mammalian cell culture technologies to meet the future commercial requirement... Show more »

Boston Institute of Biotechnology develops and runs reproducible, robust and scalable microbial fermentation and mammalian cell culture process for the production of therapeutic protein and antibodies. We have years of experience with fermentation and mammalian cell culture technologies to meet the future commercial requirement such as high throughput process development technologies, disposable mini bioreactors, high cell density screening, and complex system optimization.
Our key equipment includes Applikon micro-Matrix, DASGIP® Benchtop Bioreactors, 50L Sartorius D30 Bioreactor, mass flow controllers for gas mixing, Terumo sterile tubing welder, biosafety cabinet, Nova Bioprofile 400 Analyzer, YSI, Innova 4330 shaker incubator and Infor HT Multitron shaker incubators, etc.

We have experience with microbial fermentation and mammalian cell culture from lab scale to manufacture scale (e.g., 10mL minibioreactor , 2000L flexible bioreactor for mammalian cell culture, and industrial fermentor up to 500 m3).
We can help you transfer, scale-up or scale-down the developed bioprocess to fulfill your needs of industrial production. We can also help you troubleshoot any process related problems no matter the process is in R&D or manufacturing stage.

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Chemistry and Materials
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Liquid Chromatography
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Formulation Services
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DNA
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Business Development & Support Services
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Biology
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Cells and Tissues
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Cell and Tissue Culture
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Purification Services
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Protein Services
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Microbiology, Virology, and Parasitology
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Analytical Chemistry Services
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Chromatography
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Manufacturing Services
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Product Development, Testing, and Packaging
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Nucleic Acid Services
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Biochemistry & Molecular Biology
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Product Testing Services
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Product Testing Services

Product Testing Services

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