Process Development & Analytical Solutions
Our Process Development and Analytical services are designed to provide a seamless and efficient journey, enabling you to overcome common roadblocks and bottlenecks while minimizing risks and costs.
Go Further with our Process Development & Analytical Solutions
Our Process Development and Analytical services empower you to overcome complex challenges in cell therapy development. We create a transition plan with the goal of developing scalable and reproducible manufacturing processes that meet the phase appropriate regulatory and quality requirements and are tailored to the needs of each client and product.
Our Collaborative Approach
Our Process Development and Analytical teams collaborate closely to gain a comprehensive understanding of the critical quality attributes of cell therapy products. Through their concerted efforts, they design robust and practical quality control testing programs tailored to each product. These meticulously developed testing programs ensure that the cell therapy products delivered to patients meet the highest quality standards, prioritizing patient safety and therapeutic efficacy.
Our Process Development & Analytical Capabilities
The Cellipont Bioservice’s team has comprehensive scientific knowledge and experience spanning the entire process, allowing us to provide tailored solutions to propel your program forward. We support both autologous and allogeneic processes, and our experience includes CAR-T, T-Cell, fibroblasts, OP-9, AD-MSCs, primary cells, iNK, K562 and pluripotent stem cells.
Cell Line/Source Evaluation and Characterization
- Evaluation and characterization of various cell sources (primary cells, cell lines, stem cells)
- Optimization of cell isolation, expansion, and banking processes
- Development of robust cryopreservation and thawing protocols
Process Development and Optimization
- Design and optimization of cell culture processes (media, feeding strategies, bioreactor conditions)
- Development of scalable upstream and downstream processes
- Optimization of gene transfer/editing processes (e.g., viral vectors, electroporation)
- Establishment of robust cell activation, expansion, and harvesting protocols
- Development of purification and formulation processes
Analytical Development
- Development and validation of analytical methods for product characterization
- Establishment of in-process control and release testing assays
- Potency assay development (e.g., cytotoxicity, cytokine release, proliferation)
- Rapid sterility and mycoplasma detection methods
- Impurity and contaminant testing (e.g., residual host cell proteins, host cell DNA)
- In-house techniques include: flow cytometry, qPCR/RTqPCR, ELISA, cytokine expression analysis, cell-based assays and cell viability and vitality testing
Purpose-built Facilities
Our 76,000 sq. ft. facility in The Woodlands, TX, is purpose-built for cell therapy development and manufacturing. Designed to meet the highest quality standards and anticipate future regulatory requirements, our facility features:
- 7 cleanrooms dedicated to cell therapy development
- QC laboratories for comprehensive analytical testing
- Temperature-controlled storage for critical materials
- Segregated shipping bays for efficient logistics
- Warehouse and administrative offices
This cutting-edge infrastructure enables us to offer technically superior and highly responsive cell therapy process development services to our clients.
Advanced Technology Platforms
Celllipont Bioservices leverages the latest technology platforms to drive innovation and ensure efficient, high-quality cell therapy development. Our advanced capabilities include:
- CliniMACS Prodigy® and CliniMACS® Plus Platforms for automated cell processing
- Automated cell counters and flow cytometers for precise cell analysis
- Aseptic filling and closed processing systems for sterile operations
- Real-time PCR and digital PCR systems for genetic analysis
- Automated immunoassay and extraction systems for protein and nucleic acid analysis
- Real-time cell analysis systems for continuous monitoring
Our investment in state-of-the-art equipment enables us to deliver superior results and accelerate time-to-market for our clients’ cell therapies.
Why Partner with Cellipont Bioservices for Cell Therapy Process Development?
Leverage Unparalleled Expertise
Partner with Cellipont Bioservices to leverage our team’s extensive experience in cell therapy process and analytical development.
Accelerate Your Time-to-Market
Cellipont Bioservices’ tailored solutions and adaptable workflows enable us to reduce development timelines significantly.
Maximize Cost-Efficiency
Access Cellipont Bioservices’ state-of-the-art facilities and specialized equipment without the need for substantial capital investment.
Mitigate Risks and Ensure Compliance
Leverage Cellipont Bioservices’ proven quality systems, regulatory expertise, and established track record to mitigate risks of delays or failures.
Benefit from End-to-End Support
From process development to clinical and commercial manufacturing, Cellipont Bioservices offers seamless integration and support throughout your therapy’s lifecycle, ensuring a smooth transition and consistent quality.
Partner with us and experience a seamless journey, accelerating your path to success while minimizing risks and costs.
Contact us at [email protected] for more info on our PD & Analytical services.