BIB moved into our Southborough facility and began laboratory research and development operations in 2015.
What are your offerings, pieces or whole processes
We offer full services or partial services from consulting, microbial strain (mammalian cell line) development, upstream microbial fermentation/mammalian cell culture process development, downstream protein purification process development, analytical development, process characterization, technology transfer/scale-up support, and non-GMP material supplies.
What is your scale, upstream or downstream
Our upstream capacities range from high-thoughput milliliter-scale micro-bioreactors to 50L pilot scale bioreactorss. We also have 1-L Eppendorf DasGIP parallel bioreactors, 5-L and 10L 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 development.
BIB team has a lot of experience with tech transfer and scale-up, scale-down process development. In our facility, we have 1L, 5L, and 10L benchtop bioreactors as well as 50L pilot scale bioreactor. For downstream, we have 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 organisms that you work with?
We work with different types of bacteria and yeasts for fermentation and CHO/HEK mammalian cells for cell culture.
Do you have a QA/QC dept?
We are a GLP (non-GMP lab). We do offer analytical development
Our documentation quality is top-rated. Although we do not have QA/QC department here in BIB, 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.