---
name: Boston Institute of Biotechnology, LLC
slug: bostonbib
site: cdmo
website_domain: bostonbib.com
summary: Full-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy manufacturing from cell line development through commercial-scale fill/finish. Headquartered in Southborough, United States.
tagline: Full-service CDMO for mammalian, microbial, gene therapy, and cell therapy manufacturing.
founded_year: 2015
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: US
tier2_domain_verified: false
updated_at: 2026-09-21T07:03:40.925Z
services_count: 2
modalities_count: 5
indications_count: 0
locations_count: 1
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Boston Institute of Biotechnology, LLC

Full-service CDMO for mammalian, microbial, gene therapy, and cell therapy manufacturing.

Listed on cdmo.directory.

## Summary

Full-service CDMO offering cGMP and non-GMP mammalian, microbial, gene therapy, and cell therapy manufacturing from cell line development through commercial-scale fill/finish. Headquartered in Southborough, United States.

## At a glance

- Founded: 2015
- HQ country: US

## Services

- Analytical Method Development & Validation
- ICH Stability Studies

## Modalities

- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Gene Therapy
- Cell Therapy
- Peptide

## Locations

- Headquarters, Southborough, Massachusetts, United States

## Long description

## 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.

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_Profile last updated: 2026-09-21T07:03:40.925Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.