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Frequently Asked Questions and Answers

CDMO for Biologics and Gene Therapy

BIB and its FAQS

The Boston Institute of Biotechnology, LLC is a fast-growing contract development and manufacturing organization (CDMO) that provides a full spectrum of process development and manufacturing services for biologics and gene therapy

Check our Frequently Asked Questions

How long have you been in business?

Boston Institute of Biotechnology, LLC moved into our Southborough facility and began laboratory research and development operations in 2015.

What are your offerings?

We offer full services from consulting, cell line/strain development, upstream cell culture/ fermentation development, downstream purification development, analytical development, process characterization, technology transfer, non-GMP tox material supplies, and GMP production.

What is your scale, upstream and downstream?

Our upstream capacities range from high-throughput milliliter-scale micro-bioreactors to 50L pilot-scale bioreactors. We also have 1-L Eppendorf DasGIP parallel bioreactors, 5-L, and 15L benchtop bioreactors.

For our downstream capacities, we have AKTA Purifier 10, AKTA Explorer 100, and pilot-scale 6mm Skid Bioprocessor that can handle up to 200L/hr purification.

Do you offer scale-down development?

Yes, BIB provides scale-down model development and qualification.

BIB team has extensive experience with tech transfer, scale-up and scale-down process development. In our facility, we have 1L, 5L, and 15L benchtop bioreactors as well as 50L pilot-scale bioreactor. For downstream, we have AKTA Purifier 10, AKTA Explorer 100, and pilot-scale 6mm Skid Bioprocessor that can handle up to 200L/hr purification.

The documentation quality in BIB is top-rated to support GMP tech transfer.

What are the Expression Hosts that you work with?

We work with different types of bacteria and yeasts (E. coli, B. subtilis, P. pastoris, etc)  for fermentation; mammalian cells ( CHO, HEK, NS0, etc) and insect cells (Sf9) for cell culture.

 

Do you have a QA/QC dept?

Yes. We have both QA and QC departments in our GMP facility.

Our documentation quality is top-rated. Our team was trained to prepare the documentation like batch record and SOP using GMP standard through years of GMP tech transfer experience from previous world-leading CMO.

Do you supply preclinical materials?

YES. We offer manufacture of non-GMP pre-clinical materials. Our upstream capacities range from 1L up to 50L bioreactor for fermentation and cell culture.

Do you offer scale-up services?

Yes. We can scale our 50L to most manufacturing scales. BIB has scale-up experience from shake flasks up to thousands-liter (or even hundred thousands-liter) bioreactor. With our experience, all of our developed processes are suitable for manufacture-scale.

Do you provide tech transfer and scale-up documentation?

Yes. We offer a full array of development reports, scale-up reports and tech transfer documents. All of the documents from BIB follow the GMP standard.