Boston Institute of Biotechnology, LLC

Overview

Boston Institute of Biotechnology (BIB) is a full-service CDMO partner providing contract manufacturing and development services for biologics and gene therapy. The company operates integrated facilities supporting mammalian, microbial, and gene therapy platforms with cGMP and non-GMP capabilities.

Core Services

Cell Line & Strain Development

• Mammalian cell line development (CHO, HEK, NS0, Sf9) with demonstrated capability to produce up to 10 g/L monoclonal antibodies
• Microbial strain development (E. coli, B. subtilis, P. pastoris)
• 12+ years of hands-on process characterization (PC) study experience

Process Development

• Upstream process development for recombinant proteins, viral vaccines, and gene therapies
• Downstream purification and characterization
• Quality-by-design (QbD) driven DoE optimization
• Scale-down modeling to 1L parallel platform
• Next-generation PC studies reducing time and cost by 30–50% versus traditional methods

Analytical & Formulation Development

• Analytical method development and optimization
• Assay qualification and transfer
• Forced degradation and structure elucidation studies
• Formulation screening (buffers, excipients, pH, salts, osmolytes, surfactants)
• Lyophilization cycle development
• ICH stability studies (long-term, accelerated, stressed conditions)
• Drug product process characterization and validation

Manufacturing & Fill/Finish

• Upstream capacity: Microbial (50L–30,000L with high-cell-density fermentation); Mammalian (200L–30,000L); Gene Therapy (200L–2,000L); pDNA (50L–500L)
• Downstream: AKTA Purifier 10, AKTA Explorer 100, pilot-scale 6mm Skid Bioprocessor (up to 200L/hr)
• Drug product: Vial filling (90,000 pcs/hr liquid; 7.5 m² lyophilization area, max 20,000 pcs/batch), pre-filled syringes (1,800 pcs/hr), drug-device combination products
• Ultra-large scale: World's first 50,000L mammalian cell production line; total facility capacity over 200,000L

Gene Therapy & Viral Vectors

• pDNA, AdV, and AAV vector production from integrated production site
• Multi-expression suspension and adherent platforms (HEK 293, SF9)
• Efficient AAV purification platform
• QbD-driven DoE optimization for AAV production
• Robust analytical assays for viral vectors

Specialized Programs

• Blue Whale Program: PanFlex-driven, financially risk-free manufacturing solution reducing construction time and cost by 50%
• PanFlex Engineering: Facility construction and de-risking services

Regulatory & Quality

• QA/QC departments in GMP facility
• GMP-trained documentation team with batch record and SOP expertise
• cGMP and non-GMP production capabilities
• Tox and clinical manufacturing support

Facilities

• Southborough facility (operations began 2015)
• Multiple production sites (Zhangjiang P01, Lingang IP02, IP03)
• High-throughput micro-bioreactors, 1L Eppendorf DasGIP parallel bioreactors, 5L and 15L benchtop bioreactors

Sustainability

• Hazardous and biological waste collection and safe disposal via third-party service
• Battery recycling program
• Single-use consumables prioritized to reduce water and waste