Established, Robust, And Flexible Quality Management System
BioCentriq has a comprehensive and established quality and compliance function with the personnel, systems, and procedures in place to apply phase-appropriate compliance and a quality-first approach to every program. Both Quality Assurance and Quality Control experts will be involved with your program from the very beginning as an integral part of the team starting with knowledge transfer and culminating with the release of your product.
Members of the quality team will be engaged in everything from the initial qualification of the rooms and equipment to the validation and qualification of assays used during your manufacturing process and the successful release of your drug product or drug substance.
Why BioCentriq?
- Current Knowledge of C & GT Specific Regulatory Guidance
- Experience With Phase-Appropriate Compliance
- Collaborative & Transparent Approach to Quality
An Overview of BioCentriq's Quality & Compliance
Since our founding, we have established the quality systems, team and procedures to support the development and manufacturing of novel cell and gene therapies. This spans the testing of materials through to release and even regulatory support services.
Quality Assurance
The Quality Assurance team at BioCentriq has overall responsibility for ensuring that all functions – from manufacturing to quality control, to supply chain management and facilities and engineering – are compliant with both regulatory and cGMP guidelines and standards. The goal is to ensure that we produce a safe and effective product and that all activities are conducted in a controlled and transparent manner with the appropriate supporting documentation. Below is a list of some of the activities the Quality Assurance team will be responsible for as it relates to your program.
- Manage BioCentriq’s Quality Management System (QMS) which is MasterControl
- Conduct all batch release activities, including the review of batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable
- Approve all release documentation including COT, COA and product labels
- Provide on-site support and guidance for manufacturing teams
- Release raw materials and components
- Provide key input and manage documentation of change controls, GMP investigations, OOS incidents and CAPAs
- Lead all partner and vendor audits
- Manage continuous improvement programs
- Ensure appropriate levels of training are conducted and training records available
- Maintain BioCentriq’s Site Master File
- Establish quality agreements with partners
- Oversee all vendor qualification activities
- Support client specific regulatory submissions and interactions as appropriate
Quality Control
A key aspect of being able to release your drug product for use in clinical trials is being able to demonstrate that you’ve met minimum safety standards with compendial studies such as sterility, mycoplasma, and endotoxin testing. Additional non-compendial analytics specific to the specifications of your product may also need to be tested. BioCentriq has the right Quality Control (QC) experts, laboratories, equipment, methods, and vendor relationships in place to make sure you can supply the data you need to be able to demonstrate product safety and adherence to drug product specifications. The QC team will work with you and the rest of the BioCentriq team to do the following:
- Qualify the methods used to test your product to ensure suitability
- Evaluate which testing can be performed in-house at BioCentriq and which should be outsourced
- Establish data that can be used to support your IND submission as needed
- Confirm sampling plans required to support your in-process and release testing
- Execute tests and publish results required to support your product release
- Conduct in-process and release testing using methods such as qPCR, rapid micro methods, flow cytometry, ELISA, and automated cell counting
- Test and provide confirmation of results to release incoming and prepared or manufacturing materials
- Leverage their network of approved and qualified CROs as needed
Digital Quality Management System
BioCentriq has deployed MasterControl as its digital quality management solution, which provides us with an electronic system for controlled documentation, management of training records, automation of training tasks, reporting to demonstrate compliance, execution of change controls, reporting to support audits, and much more.
Support for Chemistry, Manufacturing, and Controls (CMC)
Throughout the course of our work with you, the BioCentriq team will help ensure that you understand and have considered the FDA guidelines for the CMC portion of your IND submission(s) and created, verified, and submitted everything you need to demonstrate that you have met the requirements. This includes making sure you can demonstrate the identification, quality, purity, and strength of your drug as well as communicate how any safety issues might be addressed. Any differences between the drug product planned for use in clinical studies and that used in animal toxicology studies will also have to be described.
Regulatory Advisory Services
If needed, BioCentriq can also supply additional regulatory advisory services to guide you in the development of your submissions and applications, support your interactions with the regulatory agency and its representatives, or walk you through the impact of specific guidelines and requirements. This includes making sure you can demonstrate the identification, quality, purity, and strength of your drug as well as communicate how any safety issues might be addressed. Any differences between the drug product planned for use in clinical studies and that used in animal toxicology studies will also have to be described.