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Frequently Asked Questions and Answers

CDMO for Biologics and Gene Therapy

We are a fast-growing contract development and manufacturing organization (CDMO) and provide 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.

How do you ensure seamless integration of your services to support the full scope of our business?

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

Can you provide examples of how you've handled project challenges in the past?

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.

How do you ensure quality and compliance in your manufacturing operations?

We have robust quality systems in place, including:

  • Follow QbD methodologies during tech transfer, process development and manufacturing.
  • Follow Operational Excellence principles: Lean manufacturing, Six Sigma, Kaizen
  • Prompt closure of quality events like change controls, CAPAs, and deviations
  • An established internal audit program to continuously improve our quality systems
  • Effective change control and deviations management processes
  • Continuous improvement efforts that enhance quality and efficiency
  • Proper establishment, validation, and documentation of all testing procedures
  • Adherence to all applicable GMP regulations and guidelines

How do you manage the supply chain for your drug substances and other critical inputs?

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

How do you address concerns over the BIOSECURE Act and compliance with regulations??

We understand the concerns raised by the BIOSECURE Act and are committed to full compliance. Our global operations are structured to ensure the protection of our clients’ intellectual property and data:

  • We do not use any prohibited biotechnology equipment or services from the companies named in the BIOSECURE ACT, including MGI, Complete Genomics, or WuXi AppTec.
  • BIB is a global CDMO, operating in the US and China. Our GMP manufacturing currently takes place in Shanghai and our R&D activities are conducted in our headquarters in Southborough, MA, just 30 minutes west of Boston, MA. In addition, we have a business development location in San Francisco, and we are expanding into Europe this year, 2024.
  • We have robust data security and access controls in place to protect client intellectual property and data, with a strong track record of successful technology transfers between our global sites, ensuring consistent quality and compliance standards across our entire network.
  • As we expand our global footprint, we will continue to prioritize compliance with all applicable regulations, including the BIOSECURE Act, to give our clients full confidence in our operations.

What sustainability initiatives do you have in place?

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.