Boston Institute of Biotechnology, LLC

Overview

Boston Institute of Biotechnology (BIB) is a full-service CDMO partner providing cGMP and non-GMP contract manufacturing services for biologics, including mammalian cell culture, microbial fermentation, gene therapy, and cell therapy modalities.

Development Services

• Cell Line Development: Strain and cell line engineering for mammalian (CHO, HEK, NS0) and microbial (E. coli, B. subtilis, P. pastoris) expression systems, as well as insect cells (Sf9).
• Process Development: Upstream development from milliliter-scale micro-bioreactors to 50L pilot-scale bioreactors; downstream purification using AKTA Purifier 10, AKTA Explorer 100, and pilot-scale 6mm Skid Bioprocessor (up to 200L/hr capacity).
• Analytical & Formulation Development: Preformulation assessments, formulation screening (buffers, excipients, pH, salts, osmolytes, surfactants), lyophilization cycle development, and stability studies per ICH guidelines.
• Process Characterization: DP process characterization and optimization for DS thawing, mixing, pooling, filtering, filling, and lyophilization; FMEA risk analysis and process validation studies.
• Gene Therapy Services: Dedicated gene therapy manufacturing capabilities.

Manufacturing & GMP Services

• cGMP DP Manufacturing: World-class fill/finish facilities for recombinant proteins, antibodies, and peptides.
• Vial and syringe filling (1ml standard and slim type, 1,800 pcs/hr for pre-filled syringes).
• Lyophilization: 7.5 m² lyophilization area; max batch size 20,000 pcs.
• Liquid vial capacity: 90,000 pcs/hr; max batch size 100,000 pcs.
• Vial types: 2R/6R/8R/10R/14R/50R.
• Drug-device combination products (pre-filled syringes, autoinjectors, pens, larger volume devices).
• QA/QC: Dedicated QA and QC departments; GMP-standard documentation and batch records.
• Stability Studies: Formal ICH condition stability studies for DP release and shelf-life assignment.
• Tech Transfer & Scale-Up: Full array of development reports, scale-up reports, and tech transfer documentation following GMP standards; scale-down model development and qualification.
• Non-GMP Preclinical Materials: Manufacture of preclinical materials from 1L to 50L bioreactor scale.

Facilities

Operations in Southborough (established 2015) with GMP manufacturing capacity. Multiple sites referenced: Zhangjiang (P01), Lingang (IP02), and Lingang (IP03).

Sustainability

Implemented waste management (hazardous and biological), battery recycling, single-use consumables prioritization, automation and online monitoring to reduce consumables and buffer usage, and process optimization to minimize hazardous acid/base consumption.

Innovation

Developing PanFlex®, a modular, flexible biologics manufacturing system designed to improve speed and cost-effectiveness of biologics production.