Frequently Asked Questions

Of course, every project is different; however, in general, BioCentriq will move at your speed. We can typically engage as quickly as you can. Our first step is to make sure there is a good fit between what you need and our capabilities and availability.  From there, we can quickly put an NDA in place so we can discuss your technology, requirements, and timelines in detail with our subject matter experts. After that, we will craft a proposal and work collaboratively to refine it to the point where we have an agreed upon statement of work that we can convert to a contract. Once executed, we will assemble the team and start with a project kick-off meeting that gets all parties aligned and educated so from that point forward we are working in lockstep to reach shared goals. 

We assign a dedicated project manager to your program who has relevant experience and background and can quickly get up to speed on the critical success factors for your project.  You will assign a counterpart from your team who will be the primary point of contact for your organization. These two individuals will be in constant contact throughout the life of the project to make sure that both parties have everything they need to be successful including a clear understanding of timelines, dependencies, requirements, action items and project risks.

Typical project management activities and deliverables  

• Weekly project meetings with all core team members from both organizations 
• Weekly (or during certain times even daily!) project manager check-ins 
• A continuously updated and detailed project plan
• Action and documentation trackers
• Bills of material for all project phases (process development, pilot runs, engineering runs, clinical manufacturing, QC, Analytical method development, etc.)
• Ad-hoc meetings as required to address key issues in process development, analytical method development, outsourced testing, manufacturing, supply chain, documentation and more. 
  

The structure of every project team is dependent on the scope and objectives of each project; however, in general, each project is assigned a “core” team consisting of the following: 

• Primary project manager
• Project management associate (if needed)
• Technical lead (someone expert in your cell line, platform, process, or vector)
• A primary point of contact or lead from the following areas: process development and/or MSAT, quality control, quality assurance, manufacturing, and supply chain.
  

This “core” team will leverage and draw from their colleagues as required to support the success of your project. 

BioCentriq is uniquely equipped to price our projects according to client requirements. We price our manufacturing projects based on utilization of the clean rooms and the labor and time required to manufacture your product. We can offer you a consistent monthly price that is inclusive of both clean room utilization and lot or batch production based on your anticipated manufacturing schedule, or we can offer you a model that distinguishes between monthly clean room utilization and batch price, allowing you a bit more flexibility to scale up or down your manufacturing as well as the opportunity to maintain your clean room booking at a lower cost during lulls in production. Our process development and workforce programs are typically priced using a fee for service model.

We find the average tech transfer can take as long as 12 to 18 months to complete. However, BioCentriq utilizes a rapid or accelerated tech transfer process that consistently allows us to complete tech transfer in as short as six months.

The length of the tech transfer process depends entirely on the current state of your process and documentation and whether or not you are willing to leverage some of the "off-the-shelf" assets BioCentriq has developed that can be retrofitted for your product. 

You may also opt to take advantage of the LEAP Advanced Therapy platform which leverages our Rapid Tech Transfer process and includes additional benefits in terms of pre-existing documentation, at times, modality specific assets, such as proven feeder lines for NK cell therapies, and pre-qualified personnel, equipment, analytical methods and facilities.

We start the process with knowledge sharing. Your team will share all available documentation, including current protocols and batch records, training documents, results of initial studies, and testing, BOM (bill of material) required for your product, drug product and drug substance specifications, CPP (control process parameters), QBD (quality by design) artifacts, and CMC documentation from any existing IND or other applications.

Feasibility Study

Once the BioCentriq team has reviewed that documentation, the teams will discuss whether anything is needed prior to proceeding to the next step, which would be a feasibility study conducted in our pilot plant.

Process Development - Optional

Sometimes the teams agree or anticipate from the beginning that additional process development would be required. At other times, process development work is not expected, and the goal is to move to clinical manufacturing as quickly as possible.

Pilot Runs

After the BioCentriq team has completed the feasibility study and both teams acknowledge success, we will move to pilot runs, which are conducted in our pilot plant at a scale that imitates or approaches the scale and process planned for clinical manufacturing in a GMP environment. Most of our project plans call for anywhere from one to three pilot runs.

Engineering Runs and GMP Readiness Activities

Lastly, we learn from pilot runs and prepare for engineering runs in the GMP environment. That readiness activity typically includes refinement and ordering of an engineering run BOM, operator training, conclusion of any analytical method development work, and creation of an engineering run protocol and draft GMP documentation, such as master batch records, SOPs, and release documents.

BioCentriq employs a hybrid team model. We always welcome people in plant. Clients are encouraged to visit our pilot plant during tech transfer and work alongside our R&D and MSAT teams to help facilitate knowledge share and troubleshoot any challenges that arise as our team strives to scale up or scale out your technologies or otherwise optimize your process for clinical manufacturing. During clinical manufacturing, clients must of course be qualified as needed to enter our GMP facility, but again, our welcome to observe all manufacturing processes, and as appropriate and in accordance with our quality systems, can even operate in the suites with our team.