CGMP MANUFACTURING FOR ADVANCED THERAPIES
Successful manufacturing of advanced therapies begins in the early pre-clinical phases and continues throughout the entire drug development journey. At Rentschler Biopharma, we understand the manufacturing complexities and regulatory challenges of advanced therapies and tailor our offering to your unique program needs. By leveraging our scientific expertise and advanced technologies, we help you achieve your milestones and meet the highest regulatory standards, accelerating your path to commercialization.
Full Suite of cGMP Manufacturing Capabilities
At Rentschler Biopharma our viral vector expertise, combined with our purpose-built cGMP-licensed manufacturing facility, ensures we can accommodate the production of your advanced therapies at any scale. We have specialized experience across multiple serotypes and viral vectors types, including adeno-associated virus (AAV) and lentivirus vectors (LVVs). With our innovative toolbox, expansive capabilities, and advanced single-use technologies, we consistently prioritize precision and innovation from project inception to delivery, ensuring a robust foundation for your viral vector manufacturing journey. Our cGMP manufacturing capabilities include:
- Purpose-built cGMP-licensed manufacturing facility up to 200 L suspension bioreactor scale
- Flexible and independent manufacturing suites and cutting-edge manufacturing equipment
- Highly-trained GMP operational staff to support streamlined scale-up and seamless technical transfer
- cGMP-regulated, secure warehousing facilities and cGMP-controlled cell bank storage facility
Manufacturing Services for Advanced Therapies
At Rentschler Biopharma we understand the complex journey of bringing an advanced therapy to market and can tailor your viral vector programs to your unique needs, enabling you to design your path to success. Our state-of-the-art facility and expert team are here to optimize your viral vector development and streamline your manufacturing process to help you achieve your milestones. Our comprehensive manufacturing services for advanced therapies include:
- Non-GMP pilot and engineering drug substance production runs at a 60- 200 L scale for pre-clinical, tox and safety batches
- cGMP starting material and drug substance production runs at a 60- 200 L scale for clinical and commercial supply
- In-house PD, analytical development and QC laboratories, ensuring a seamless transition to cGMP manufacturing
- Formulation development and fill-finish drug product manufacturing capabilities in collaboration with our preferred network of trusting partners
- Drug substance and drug product release and stability testing
Quality Control Services
For your project’s success, we conduct comprehensive characterization, drug substance and drug product release tests in our in-house, state-of-the-art quality control (QC) laboratory. Our extensive network of trusted and qualified partners adds depth to our quality control capabilities for your specific needs:
- QP batch certification: Our team of experienced Qualified Persons (QP) play a vital role in bringing your advanced therapies to market by providing QP certification for every batch while maintaining the highest quality standards.
- Licensed cGMP-compliant facility: Our MHRA-approved Good Manufacturing Practice (cGMP) license enables us to manufacture high-quality viral vector products to support your clinical and commercial needs.
- Quality Management System (QMS): Our robust QMS system underpins every aspect of the process development and manufacturing process — from initial concept to the production of bulk drug substances — ensuring the delivery of safe, high-quality and efficacious gene therapies.
Highlights
Get in Touch with our Business Development Team
Are you interested in learning more? We look forward to hearing from you!
Robert Panting
General Manager, ATMP