- Master cell banking
- Upstream GMP manufacturing
- Downstream GMP manufacturing
- Fill and Finish
- Quality Assurance
- Quality Control
- Documentation to support IND filing
Master Cell Banking
Master Cell Banks (MCB) are needed for cell lines used to produce products in manufacturing campaigns.
A MCB is generated from a research cell bank (RCB) when cell line development is completed. Cells from a RCB are thawed and expanded, and when cell counts reach the desired number, a MCB is prepared and stored in a LN2 freezer.
Samples of the MCB are taken for characterization, stability and safety studies. At JOINN Bio, tests for MCB may include the following to ensure quality of our Master Cell Bank:
Master Cell Banking Characterization
JOINN Biologics’ upstream manufacturing provides on time, high quality, compliant cGMP production services from vial to final production vessel using stainless steel bioreactors up to 1000L production capacity, and single use bioreactors up to 500L production capacity.
The upstream manufacturing suites are equipped with a wide variety of cell culture production equipment as well as many advanced in-process testing technologies that include:
- Rocker-based Bioreactors
- 200L and 500L Single-use Bioreactor systems
- 50L Sartorius Stainless Steel Bioreactor systems
- 200L and 1000L ABEC Stainless Steel Bioreactor systems
- Cell culture analyzers: Vi-Cell, Cedex Bio analyzer, pH/gas analyzer, osmometer, microscopes, etc.
- Westfalia Centrifuge Skid for centrifugation
- FlexAct Depth and micro filtration skid for filtration
The equipment in our downstream GMP suites reflect the latest industry standards of protein purification, which include:
- Single use mixer system for large scale buffer preparation
- AKTA ready and AKTA ready gradient for chromatography steps
- FlexAct and AKTA flux filtration system for cross flow and tangential flow filtration for depth, viral, sterile, ultra and dia filtration needs
Fill and Finish
JOINN Bio’s Fill and Finish facility brings your drug substance to drug products, and includes:
- Fill/Finish Suite with designated preparation room.
- On-site vial washing and pass-through autoclave and depyrogenation.
- Filling and capping in Grade A/B environment.
- Aseptic liquid fill and lyophilization capabilities.
- Inspecting, labeling and packaging of filled drug products.
JOINN Bio’s Quality team is committed to provide the highest quality products and services to clients.
Our QA system has the following attributes:
- Highly experienced team committed to complying with all appropriate regulations.
- Quality Management System fully aligned with the applicable regulatory guidelines.
- Promote an engaged workplace culture that values continuous quality improvement.
- Ensure a suitable quality policy communicated and understood by all employees.
- Periodically evaluate and continually improve the effectiveness of the quality system.
- Define processes for establishment, regular review, and improvement of quality objectives.
- Exceptionally experienced validation team to lead facility, equipment and process validation projects.
- Expertise in managing the qualification of materials, vendors and service providers.
- Well-experienced in performing internal/external audits and managing regulatory inspections.
Our QC system has the following attributes:
- Develop, qualify and validate new testing methods by exceptionally skilled analysts.
- Provide in-house analytical testing capabilities to support ongoing cGMP operations.
- Perform USP and other compendial monograph tests.
- On-site cleanroom environment monitoring and trending.
- Periodic sampling, testing and trending of critical utilities.
- Conduct in-process material and final product release tests.
- Develop and execute product storage and stability testing programs.
- Support process development/improvement and process validation projects.