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Arthur Michaud

Business Intelligence Analyst
West Coast

Howard Jan

Director of Business Development
CMC Management

Paul Wycliffe

Vice President of Business Development
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Kyle Tibbert

Director of Business Development
North America

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Frequently Asked Questions

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

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.

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.

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.

BIB has a number of processes in place to promote seamless integration of our services, including:

  • Our mission is to provide patients with high-quality, affordable biological medicines with our trusted and faithful partners
  • Dedicated project management to coordinate activities across different groups and sites
  • Mechanisms for experts from various functions to join the project team as needed
  • Shared systems and templates to facilitate knowledge transfer between their facilities
  • Aligned incentives and KPIs across the organization, not siloed by individual sites

We have implemented several sustainability initiatives within our operations:

  • We collect both liquid and solid hazardous and biological wastes and ensure their safe disposal through a third-party service.
  • Our commitment to environmental responsibility extends to battery recycling.
  • We prioritize the use of single-use consumables wherever feasible, aiming to reduce water and hazardous chemical consumption.
  • Utilizing automation and online monitoring tools enables us to minimize consumable and buffer usage, as well as streamline employee time.
  • Additionally, we continuously develop and optimize our processes to minimize the usage of hazardous acids and bases, further enhancing our sustainability efforts.
  • Furthermore, our innovation programs are geared towards promoting more productive and efficient manufacturing processes.

As part of our mission, BIB aims to accelerate biologics manufacturing with our revolutionary new biologics manufacturing system, PanFlex®. PanFlex® uses a modular, flexible approach to significantly improve the speed and cost-effectiveness of biologics production.

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.
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.

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.

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.
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.

We are committed to open and transparent communication when challenges arise. While we keep our clients data and past projects protected, our team at BIB has experience addressing unexpected issues that arise during drug development projects. We perform risk and gap assessments before and after each stage gate: Typical stage gates are (1) TT from client to BIB PD, (2) adaptation run, (3) demo/confirmation run, (4) engineering run, (5) GMP run. We close the gaps or mitigate the risks before we move forward to the next stage.

During the process, we emphasize the importance of open and transparent communication when challenges occur, quickly informing the client, leading problem-solving efforts, and provided updated plans to keep the project on track. We always strive to learn from such experiences and incorporate those lessons to become a better partner.

BIB takes a proactive approach to supply chain management, including:

  • Identify long lead items and order them as soon as processes are locked, or based on the risk assessment order them as soon as the project starts.
  • Proper storage, labeling, and identification of raw materials
  • Robust supplier qualification and evaluation processes, including backup or alternative suppliers
  • Ability and willingness to procure and store sufficient raw material buffer stock
  • Adherence to all serialization and traceability requirements
  • Ample storage and distribution capabilities to meet client needs
BIB is a full service CDMO partner offering cGMP and non-GMP mammalian, microbial, gene therapy and cell therapy services.
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