Process Development Services for Advanced Therapies

We provide a comprehensive approach to developing phase-appropriate, robust, scalable and commercially viable processes for your advanced therapies. Drawing on our extensive viral vector expertise, our processes are designed to adhere to current cGMP standards and deliver customized solutions for each development phase, enabling you to achieve commercial success for your viral vector program.

Process Development Capabilities

In the complex cell and gene therapy (CGT) space, developing robust, scalable and commercially viable manufacturing processes often presents the biggest challenge to the successful commercialization of advanced therapies. Our experts provide customized solutions for process development (PD), cGMP manufacturing and advanced analytics to support you in the production of high-quality and safe gene therapy products.  

Our PD scientists have in-depth technical expertise across various vector types, including adeno-associated virus (AAV) and lentivirus vectors (LVV). Complementing our PD capabilities, our project management and regulatory teams ensure efficiency and compliance from pre-clinical phase to commercialization, accelerating your project’s journey to market.

Viral Vector Expertise

Our suspension processes can be customized to meet your product, indication and delivery route requirements. By starting with your end goals in mind, we design scalable, robust and safe processes and provide a seamless transition of your viral vector program from the lab through clinical development and all the way to market. We offer comprehensive expertise in several viral vector types, including: 

Adeno-associated virus (AAV)

Lentiviral vector (LVV)

Bespoke projects for alternative therapeutic viruses and modalities

Get Your Advanced Therapies Right From the Start

Analytical Services For Advanced Therapies

Rentschler Biopharma CDMO scalable and robust upstream process development for CGT

Analytical characterization is crucial for the development of scalable cGMP manufacturing processes for advanced therapies that meet the highest quality and safety standards. It involves understanding of the product’s mechanism of action, identification of the Critical Quality Attributes (CQA) in relation to Critical Process Parameters (CPP).  Our experienced analytical scientists excel in the development of custom bioassays  to achieve successful characterization of your advanced therapies.

 

Learn more about our analytical services

Highlights

State-of-the-art PD laboratories equipped with single-use bioreactors scaling from 0.3 to 50 L, spanning from lab to pilot scale.
In-house QC, analytical and stability testing services and QP release
Experience working with multiple serotypes and viral vector types, including  AAV and LVV, for various gene therapy applications
Easy access to our novel toolbox for viral vector manufacturing, license free and with no tie-ins
Partially customized or fully bespoke solutions for process development based on your specific viral vector program needs
Your success is our priority— we collaborate closely with you as an extension of your team
A flexible business model tailored to your unique needs, ensuring a true partnership every step of the way

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

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

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