Process Development Services for Cell & Gene Therapy
Successful bioprocess development for groundbreaking cell and gene therapies (CGTs) requires efficient and reliable manufacturing. We, at Rentschler Biopharma, draw on deep experience in biopharmaceuticals, leveraging our Adeno-associated virus (AAV) vector process development expertise to deliver phase-appropriate, robust, and scalable processes.
Whether you’re navigating upstream or downstream processes or planning scale-up for cGMP manufacturing, our techniques are optimized to meet your CGT needs at every stage of drug development. Our expert project management and regulatory support ensure efficiency and compliance from pre-clinic through Phase III. And by fostering a collaborative environment, we aim to accelerate your journey to market, making your vision a tangible reality.
Streamlined Upstream Development and Tailored Optimization for CGT
Our skilled scientists provide scalable and robust upstream process development for your CGT project. We use a holistic approach, providing a seamless program transition from the laboratory through clinical development to market.
- Tailored solutions: We understand that each CGT project is unique, which is why we offer a personalized approach to process development. Using our state-of-the-art, customizable AAV platform, we rapidly develop and fine-tune processes to align with your desired product profile needs. This approach significantly expedites the path to delivering your product to patients in need.
- Cutting-edge facilities: Our process development laboratories are equipped with single-use bioreactors, capable of operating at lab scale and extending to larger pilot scales. This flexibility empowers us to meet your experimental needs across a broad spectrum, ensuring that your CGT project receives the attention and expertise it deserves.
Advanced Downstream Process Development and Enhanced Purification for CGT
We offer an all-encompassing approach to downstream process development and purification, catering to your specific CGT project needs. Our integrated downstream equipment not only supports process development, but also ensures a seamless material supply.
- Holistic support: We collaborate closely with our trusted strategic partners to provide comprehensive support, including in-process stability studies and essential pre-clinic study assistance, giving you a solid foundation for success.
- Meticulous purification: Our integrated approach incorporates state-of-the-art techniques such as Hollow fibre-based concentration/diafiltration and a range of ready-to-use chromatography steps. These advanced methods are instrumental in meticulously purifying your product, effectively achieving the desired final concentration.
Our commitment to excellence in downstream processing and purification ensures that your CGT project benefits from the highest standards of quality and precision.
Cutting-Edge CGT Analytical Development
Our array of advanced analytical platforms for CGT process development and optimization are at the industry forefront, ensuring your product meets the highest quality benchmarks throughout manufacturing. Our experienced analytical scientists excel in the development of custom methodologies matched to the unique demands of your product profile.
Beyond development, we guarantee the seamless transfer of methods to our quality control department or trusted partner CROs, providing effective qualification, validation, and release testing.
Platform methods / Establishment |
Bespoke methods / Development |
| Host Cell Protein (ELISA) | Gene of Interest titre (ddPCR) |
| Host Cell DNA (PicoGreen & ddPCR) | Infectious titre assay (TCID50) |
| Residual DNase (ELISA) | |
| Vector Aggregation (DLS) | |
| Endotoxin (LAL) | |
| pH | |
| Osmolality | |
| VP1:2:3 ratio (cGE Immunoblot) | |
| Full Capsid Ratio (MP) | |
| ITR based genome titre (ddPCR) | |
| Capsid titre (ELISA) | |
| Protein Fingerprint (cGE Immunoblot) |
Non-GMP Toxicology Material Sourcing for Your Study
Understanding the pivotal role of non-GMP toxicology material in research, we’ve extended our capabilities to produce this critical material directly from our process development pilot plant, ensuring your studies have the resources they need.
Integrated Process From Development to Production
We are delighted to collaborate with Rentschler Biopharma on our lead program. [...] It is critical to work with a team that has strong AAV experience in our field and that will be a true partner every step of the way.
— Dr. Katie Binley, Chief Scientific Officer of Ikarovec
Highlights
Get in Touch with our Business Development Team
Are you interested in learning more? We look forward to hearing from you!