Our Modular Curator® Platform is Purpose-Built to Advance Gene Therapy Development
Andelyn’s platform solutions are designed to support the evolving needs of cell and gene therapies across modalities, stages, and complexities. From early research through clinical and commercial readiness, these platforms bring together scientific expertise, flexible process development, and scalable manufacturing to help teams move forward with clarity and confidence.
AAV Curator® Platform
Built on data and configurability, the AAV Curator® platform tailors the manufacturing process to your program’s specific needs, optimizing yields and performance. It accounts for key variables across upstream, downstream, and fill-and-finish, including materials, testing, and release parameters.
LVV Curator® Platform
Our LVV Curator® Platform uses the same proven modular approach as our AAV platform, standardized where it matters, flexible where it counts, supporting efficient development and manufacturing to meet each client’s needs.
Optimization-By-Design™
Industrializing Gene Therapy Processes with a Reductionist, Holistic, and Systematic Optimization Methodology Approach
Consistency in productivity and quality are evaluated at each stage of development and measured with enabling technologies.
Benefits of Our Platform Approach
Reduced Spending on Optimization
High Productivity and % Full Capsids driving production costs down
No MCB Generation Costs
No Tech Transfer Costs
No PreClinical/clinical Licensing Fees
Reduced time spent on opTimization
Off the Shelf (OTS) plasmids readily avaIlable
No MCB generatIon time
Supply Chain Already Established
NO TECH TRANSFER/DOCUMENTATION TIME
DMFs filed for Andelyn’s platform
Same equipment in non-GMP & GMP
Same quality systems
Integrated teams in Preclinical & Clinical
Check out our tech transfer capabilities.
Discover more about Andelyn's advanced frameworks for transferring processes and analytical technologies.
Frequently Asked Questions
What are the main components of a gene therapy production platform?
- Process Design and Optimization: QbD-guided DoEs define the design space, ensuring critical parameters are understood and controlled.
- Upstream Operations: Cell line or producer system selection, media and feed strategies, plasmid design, and transfection or induction conditions.
- Downstream Purification: Clarification, chromatography, filtration, and buffer exchange steps tuned to preserve potency and purity.
- Fill-Finish: Aseptic filling, container-closure selection, and stability-oriented formulation.
- Analytical and QC: Platform assays for identity, purity, potency, and safety, with phase-appropriate qualification and validation.
- Materials and Supply Chain: Qualified raw materials, off-the-shelf components, and established vendors to reduce lead times.
- Digital and Data Backbone: Historical data, trending, and in-process controls to drive consistency and continuous improvement.
What types of vectors are used in gene therapy production platforms?
Andelyn’s Curator® solutions support adeno-associated virus (AAV) and lentiviral vectors (LVV) as primary modalities. The AAV Curator® platform addresses serotype-specific needs across transfection conditions and purification strategies, while the LVV Curator® platform supports transient or stable systems to achieve robust infectious titer and transduction efficiency. Beyond AAV and LVV, our CGT manufacturing expertise can be applied to adjacent vector types by adapting within the same gene therapy production platform framework.
How is scalability achieved in gene therapy manufacturing?
Scalability is achieved by harmonizing unit operations from benchtop to GMP using the same equipment families, materials, and quality systems. Design-locked processes translate from non-GMP to GMP suites with minimal requalification, supported by templated documentation and DMFs filed for Andelyn’s platform. Off-the-shelf plasmids and an established supply chain reduce lead times, while consistent analytics ensure comparability across scales. This CGT manufacturing strategy enables predictable scale-up and, when needed, scale-out to meet clinical and commercial demand within the same gene therapy production platform architecture.
What is a gene therapy production platform?
A gene therapy production platform is an integrated, modular framework that standardizes and streamlines the activities required to produce viral vectors and related materials for clinical and commercial programs. Our approach unifies process development, analytics, raw material strategy, and manufacturing execution into a cohesive, cGMP-ready pathway. As a CGT manufacturing partner, Andelyn provides a gene therapy production platform that reduces variability, accelerates timelines, and improves predictability from nonclinical through BLA-enabling runs.
How do gene therapy production platforms work?
These platforms integrate configurable unit operations with data-driven controls. At Andelyn, the Curator® gene therapy production platform applies Quality by Design (QbD) and Design of Experiments (DoE) to define critical quality attributes and critical process parameters early, then locks them into reproducible workflows. Historical datasets inform risk-based decisions, and standardized materials, assays, and documentation enable consistent execution across scales. This CGT manufacturing approach orchestrates upstream production, downstream purification, and fill-finish to deliver reliable performance, lot after lot.