About - Boston Institute of Biotechnology

About Us

Empowering Progress, Accelerating Solutions

As a CDMO, Boston Institute of Biotechnology, LLC, provides full spectrum development and GMP services for microbial and mammalian derived biologics and gene and cell therapy therapeutics. This includes drug substance and drug product manufacturing capabilities.

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Years Experienced

Decades of working experience in world-leading CDMOs makes our team one of the best choices for your CMC needs.

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Projects Completed

Our technical team have completed more than 160 projects in their careers spanning from preclinical, clinical and commercial

Exciting News:

World’s First Ultra-Large Bioreactor

We have the world’s first ultra large bioreactor with a 30K working volume capacity, and over 50K total volume! This bioreactor is part of a new generation of systems that are developed to help significantly decrease cost and increase speed to market, transforming your molecules into medicines that help patients in need!

We have just completed our large-scale CDMO base for biologics with a total capacity of over 200,000L. The project has a total construction area of 123,700 square meters, including the worlds largest 50,000L mammalian cell production line.

Vision

To provide patients with high-quality, affordable medicines with our trusted and faithful partners.

Mission

Alliance for people’s health, united we make blockbusters.

Executive Summary

At the helm of Boston Institute of Biotechnology (BIB) are visionary founders and core executives who bring forth a wealth of expertise from the world’s leading biopharmaceutical CDMO companies. With an average of over 20 years of industrial experience each, our team has successfully executed over 162 projects in biopharmaceutical manufacturing, spanning research and development, production, and operations within globally-regulated markets. Notably, BIB employs an innovative and disruptive PanFlex-Engineering system, enabling the construction of biopharmaceutical production sites in half the time and cost of comparable developments. In addition, our quality system meets the requirements from FDA, EMA, PMDA and China NMPA. We’re at the forefront of revolutionizing the biopharmaceutical industry through our advanced cell line development processes. Our commitment to innovation, efficiency, and quality is not just about advancing science; it’s about bringing life-changing therapies to patients faster and more affordably. This overview provides a glimpse into how our cutting-edge techniques and collaborative approach are setting new standards in therapeutic production. The Boston Institute of Biotechnology boasts the world’s inaugural ultra-large bioreactor, featuring an impressive 30,000L working volume capacity and a total volume exceeding 50,000L. This cutting-edge bioreactor represents a pivotal advancement in the field, strategically designed to significantly reduce costs and accelerate time-to-market.

Delivering Excellence in Pharmaceutical Research and Development

At our core, we prioritize high-quality research driven by our experienced scientists and cutting-edge technologies. Our expertise allows us to significantly reduce development times, transforming processes that typically take years into months or even weeks. Whether you need solutions at the micro or pilot scale, we are equipped to deliver exceptional results.

Our Quality Management System meets the rigorous standards set by major regulatory bodies, including:

Core Values

Quality Excellence, Scientific Expertise, Operational Agility, Collaborative Partnership and Ethical Integrity

Technical core team with average 20 years experience with global leading CDMOs

Our core technical team have completed more than 160 projects in their careers spanning from preclinical to clinical to commercial. Not only do we have years of experience, that experience has surpassed a wide-array of different products across various expression systems.

Project Stage

Pre-clinical

Clinical

Commercial

Total

Expression

Products

# of Projects Experience

28

11

8

47

34

10

6

50

6

2 ---

8

2

1

4

8

6

4

18

2 ---

2

4

3

1

8

4

1

6

1

3 ---

4

13

2 ---

15

102

39

21

162

Your One-Stop CDMO Partner for All CMC Needs

As a comprehensive, full-spectrum CDMO partner, we offer solutions for every stage of your product’s life cycle.

Being a full spectrum, full life cycle CDMO partner, we are your one-stop-shop for all CMC needs.

We OFFER mammalian, microbial and gene therapy services.
We work with companies from discovery all the way to final product and commercial launch
So for cell line development we work with mammalian cells such as CHO, NSzero and Hek cells and also with bacterial strains such as e.coli, bacillus subtilis, and pichia (peeshah) pastoris. We are also able to develop processes using our own propriety EPIC-CHO cell line.
For Microbial, in addition to the strains listed on this slide, we are also able to develop processes for other microbial hosts, including native cells.

We OFFER mammalian, microbial and gene therapy services.
Now going through process development, we offer fermentation, purification, product characterization, non-GMP Tox production, analytical and formulation services.
Everything that you can see on the left side of the blue dotted line can be done at our R&D center here in Boston – so cell line development and process development.
And then to the right of the dotted line, our manufacturing and support is done in our Shanghai location, where we offer GMP production, fill & finish, regulatory, commercial production, process characterization again and QMS all the way to your final product.

You Have A Vision

We Have A Way To Get You There

Boston Institute of Biotechnology occupies a facility of 15,000 sf. including separated labs for cell culture, fermentation, purification and analytical services.

Our facility in Southborough MA, within the Biotech Hub of Metro-Boston Area, offers flexible and adaptable lab spaces designed to meet the needs of our clients.

Eight Reasons to Partner with Us

1

Full life-cycle CDMO

With a wide coverage for different needs

2

Extensive industrial CDMO experience

Providing world-class professional services

3

Full cGMP scale

From 100-2,000L up to 30,000L for commercial production, lowering cost up to 80% per gram product

4

Advanced technology platforms

Taking the lead in HHS and BARDA projects

5

Rapid delivery cycle

Reducing development timeline by QbD and DoE methodologies

6

Quality management system

Meeting requirements of FDA, EMA, PMDA, and China NMPA

7

Proprietary IP protection system

Committing to follow global standard

8

Innovative business models

Minimizing your cost and includes plant design

Locations

Don't Wait, Innovate

Alliance for People’s Health. United We Make Blockbusters

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