small molecules
biologics
cell & gene
bioscience
capsules & health ingredients
A standardized, systematic approach to tech transfers, manufacturing and pre-approval inspection readiness to reliably take your therapy to commercialization.
Once your process is established and ready to tech transfer, your next goal is to follow through with its successful commercialization. You want to ensure that your therapy will pass regulatory inspections and need a commercially viable manufacturing strategy flexible enough to adjust to varying patient demand.
Achieving these goals can be challenging when you are one of the trailblazers in an emerging market where only a few products have been approved. There is a lot of uncertainty around pricing, on the commercial viability of cell and gene therapies, while new biotech innovators are constantly popping up, competing for the same indications.
Meanwhile, regulators are making it abundantly clear that despite accelerated pathways and revolutionary efficacy, there will be no special treatment for cell and gene therapies’ approvals compared to traditional biologics. Complying with all safety and quality standards takes highly trained and experienced dedicated teams. Yet, the rapid growth in the CGT sector has led to a scarcity of talent.
Follow a proven, predictable path to take your product to market by leveraging a standardized, structured and systematic approach to manufacturing
Our New Product Introduction (NPI) program maps out your entire journey to commercialization, accounting for each key milestone with checkpoints to ensure you meet all required quality standards as your therapy progresses towards commercialization. The NPI program leverages our heritage and longstanding experience in establishing cGMP manufacturing standards, combining both corporate and local quality standards, customized for cell and gene therapies to de-risk your journey to commercialization.
You will also maintain complete oversight during your product’s lifecycle journey, enabling you to assess and validate the quality of process robustness, raw materials, analytical methods, sterility, facility, equipment, and tissue acquisition throughout this journey.
Anticipate and address potential regulators observations by focusing on your therapy’s manufacturing process
Our established, compliant facilities and processes enable you to leverage facility layouts, airflows, material storage, documentation processes and quality systems which have already proven to be suitable for commercial manufacturing and passed regulatory agency inspections for other cell and gene therapies.
As a result, you can focus on your product’s manufacturing process to withstand the scrutiny of regulatory inspections, while relying on us to complete the regulatory compliance checkpoints for the facility where it is hosted. And by minimizing risks to commercialization in this way, you’ll be able to avoid major rework, delays, and related costs that could lead to a catastrophic business loss
Ramp up and build out within an established infrastructure
With scalable capacity in state-of-the-art facilities, you’ll be able to commission GMP-certified suites and Lonza engineers to build them to your precise specifications.
This means you’ll be able to adapt more efficiently and reliably to meet changes in demand—without incurring in-house related capital and operating expenses. In the end, you’ll be able to deploy a high-yield, low-failure model for commercialization.
Our capabilities
Our cGMP manufacturing capabilities span three technologies – autologous and allogeneic cell therapies and viral vector gene therapy. Our footprint spreads across three continents, by supporting you at all stages of clinical development and commercialization, we can help you drive your pioneering therapies to market.
| Preclinical and early phase | Late phase and commercial | Support for optimized path to market |
|---|---|---|
| Manufacturability assessment | Global cGMP manufacturing capacity across 3 continents | Tissue acquisition services, Cell and viral banking |
| Process improvement & development | Global tech transfers | Customized business and operation models, facility build-out |
| Analytical assay development, qualification & validation | Commercialization readiness | Quality and regulatory set up for successful commercialization |
| Media optimization & development | Formulation & fill / finish | Regulatory consulting and services |
| Formulation & fill / finish | Storage & distribution | |