GENE THERAPY DEVELOPMENT
Innovators of tomorrow’s therapies are ready for an unconventional partner
today — the kind prepared to lead the pursuit of life-saving, life-extending
medicines by revolutionizing how they’re made, funded and scaled.
BEST-IN-CLASS VIRAL VECTOR
MANUFACTURING WITH SPEED
To meet the demand of this rapidly growing industry, we set ambitious goals to invest in, build and ultimately deploy best-in-class viral vector manufacturing platforms that incorporate cutting-edge technologies.
In addition to providing our partners with viral vectors (AAV and LVV) and other viruses, we have built the requisite Process and Analytical Development (PAD) and GMP services, capacity, and viral vector platforms which aim to enable these life-saving gene therapies to get to the clinic and to commercialization more quickly.
We'll get you where you need to go, with titers above industry standard, suspension-based platforms, and quality systems in place ensuring your success from the beginning to take you to your desired finish line. Join our partners who are already taking advantage of our best-in-class viral vector PAD and GMP biomanufacturing network.
- Other esoteric viruses
- Suspension and adherent cell culture capabilities
Accelerated Path To IND
- End-to-end cell line development, formulation, process and analytical development (PAD), with early-stage clinical manufacturing to provide flexibility and speed for first-in-human (FIH) programs
- Leverage proven platforms including SnapLVVTM, a suspension-based LVV manufacturing platform that generates enough material (20L) to support FIH autologous cell therapy developers in less than 12 months
Innovative Process & Analytical Development
- End-to-end PAD to bring product to clinic more quickly
- Adherent and suspension viral vector platforms to scale process to meet patient demand
- Comprehensive suite of stage-appropriate analytical tools and on-site QC testing
Robust Clinical & Commercial Manufacturing
- A combined experience of 100+ years in viral vector manufacturing
- Early phase to commercial tech transfer
- Clinical and commercial systems to support early-phase to commercial manufacturing of drug substances (DS) and drug products (DP) across various disease indications
- Master cell banking and working cell banking capabilities at each manufacturing facility
- Commercially-approved facilities to support late-stage and commercial programs, scales ranging from 50L to 2,000L
- Cell bank GMP Production (MCB and WCB)
- Isolator-based drug product fill finish
- State-of-the-art formulation and fill finish
Experienced CMC & Regulatory Support
- Seasoned regulatory team with an average of 20+ years of experience working alongside product development leaders to provide CMC and regulatory support from pre-clinical development to licensure
- Multi-tiered support to fit your stage of product development and needs
SETTING A VECTOR FOR SUCCESS
Our experts are ready to help you take your life-changing therapy to the next level. Let’s get started.
Let’s Start a Conversation
You’ve no doubt filled out a million forms before. But this is the first one to us – and we’re excited to hear from you. Let’s see if your biomanufacturing needs and our capabilities are a good match.