We offer a full array of key services in our
cutting-edge facility, guiding you from initial
discovery through to final delivery.

Services

Each day we work to advance innovative manufacturing
technologies that promise cures, making cell and gene
therapies more accessible to everyone.

Process Development

We offer an end-to-end solution for viral vector manufacturing, from cell line to drug product, emphasizing process robustness and quality. Our platform approach minimizes new development, allowing for the rapid creation of toxicology batches shortly after contract signing. With Quality by Design (QbD) principles, we transition directly to GMP production, saving you time and resources for study design.

Platform Bridging
Pre-clinical Material Production
Toxicology Material Production
Scale up & Out
Process Characterization
QbD & CMC Support
Analytical Development and Tox Release
Formulation Development

cGMP Manufacturing

Our commitment to quick clinic delivery and accurate execution is fundamental to our approach. With an integrated supply chain and standardized documentation strategies, we significantly reduce GMP readiness timelines and maintain a sharp focus on the CMC specifics of your program.

cGMP Cell Line
AAV Production
LVV Production
Process Validation
CMC Support
cGMP Analytical Testing
Stability Strategy Support
Assay Qualification & Validation
Formulation and Fill/Finish

Analytical Development

Our analytical services are focused on viral vector product release, emphasizing biological assays crucial for quality approval. Our team is equipped to handle everything from assay transfer to qualification and validation, aiming to effectively bring your ideas to life.

Assay Development
Assay Qualification & Validation
In Process Sample Testing
Lot Release Testing
Stability Support

Explore the facility

Our advanced facility is meticulously designed to meet cGMP standards and tailored for the efficient and scalable production of viral vectors.

Facility details

22,434 sq ft

BSL2- ISO7/ISO8

5 dedicated, cGMP suites

Cell expansion
Solution Prep
Processing (2)
Fill/Finish

Dedicated Process Development
& Toxicology (GLP)

Dedicated RUO Vector Core

On-site Warehouse
& Cold-Chain Storage

24/7 environmental monitoring of
production suites and cold storage

Integrated Analytical Suite

Cell based assays, compendial assays
Bioburden
dPCR, ELISA

Research Vector Core & PD Toxicology
cGMP Suites
Fill /Finish
QC Testing Suite
Office

Quality is at the core of what we do

Our comprehensive quality assurance program means that
viral vector products are manufactured and tested in full
compliance with cGMP regulations and adhere to FDA Good
Manufacturing Practice (GMP) requirements.

With more than 40 years of quality assurance program
management, our team has adopted a “right first time”
culture, dedicated to proactive quality program
management to ensure the quality of your product.

Let’s start
a conversation.

Connect with us

We offer a full array of key services in our cutting-edge facility, guiding you from initial discovery through to final delivery.