May 5, 2020
With record numbers of cell and gene therapies in development, Eurofins BioPharma Product Testing is investing in specialized technologies and scientific talent to tackle technical and regulatory questions around biosafety, characterization, and functionality.
The advanced therapy services space is booming, riding the wave of cell and gene therapies (CGTs) entering and progressing through the clinic. While only a handful of such products have reached commercialization, the US Food and Drug Administration (FDA) anticipates numerous approvals in the coming years based on the 900 plus investigational new drug (IND) applications it has received.
“Clinical success stories of novel cell and gene therapy advanced medicines are driving a sustained exponential growth in the sector,” Marian McKee, vice president of Biosafety,Eurofins BioPharma Product Testing, tells Bioprocess Insider. Regulatory guidance – most recently the FDA/HHS CMC Guidance for Human Gene Therapy INDs issued in January – and the fast-tracking of clinical candidates are also driving growth, as is increased investor interest.
Image c/o Eurofins
“All of these factors lead to a demand for experienced scientists and comprehensive specialized laboratory testing resources, as well as expedited timelines which drive the decisions of Eurofins’ clients as they decide which laboratories to use for GMP testing services,” says McKee.
Eurofins BioPharma Product Testing has a long history in small and large molecule biopharmaceutical testing but is now seeing extraordinary demand from the cell and gene therapy (CGT) for its services.
“Two decades ago, small molecules were the foundation of drug development and therefore the basis of many contract testing labs’ service offerings. Clinical CRO’s and large molecules were just coming into the spotlight,” says McKee. “Fast forward to present, and both small and large molecules are now standard methods for advancement of therapies, with CGT’s rapidly becoming part of the daily dialogue.
“Further, CGT’s are now growing at a faster pace as compared to large molecule R&D in the past two decades,” McKee continues. “While we are still seeing tremendous growth across all modalities, the current and potential trajectory in the CGT space is significant.”
Within the space, Eurofins offers cGMP-compliant CMC testing support to ensure the identity, potency, purity, and safety of starting materials, intermediate products, vectors, and final drug products as well as support for manufacturing process development and validation. This includes testing of raw materials, cell and viral bank services, plasmid vector testing, lot release testing, and bulk and finished product testing.
This has come about by building on a small molecule and biologics testing base and via investments focused on “specialized resources that have experience in the space, instrumentation, and new approaches to meet technical and regulatory questions around biosafety, characterization, and functionality,” says Stanley Prince, biosafety senior scientific advisor, Eurofins BioPharma Product Testing.
The firm’s cell and gene therapy hiring models demonstrate this. “On average, Eurofins is onboarding 20-40 people each week that work in our internal laboratories, work at a client site through our Professional Scientific Services (PSS) Insourcing Solutions service model, or work in our internal labs but focused on one client’s testing program through our dedicated Full Time Equivalent (FTE) service model,” Prince continues, adding that the entrepreneurial culture at Eurofins is also a factor in tackling the challenges surrounding cell and gene therapy development.
“We listen, we review, and we make targeted investments rather quickly,” says Prince. “The culture of Eurofins is to stay nimble to enable our labs to make timely investments based on projected industry trends, regulatory demands, and client needs.”
“Our FTE and PSS service models show our dedication and flexibility to meet and exceed client expectations,” Prince continues “The people that we are hiring come directly from the CGT space and can help our clients understand what is needed and challenge historical thinking to bring us all into the next generation of advanced therapy medicinal products.”
In addition to personnel, Eurofins continues to add technology to support regulatory expectations around empty/full capsid analysis (for example analytical ultracentrifugation), rapid sterility testing requirements for autologous cell therapies, and to allow more precise quantitation using molecular methods. Investments in Eurofins BioPharma Product Testing facilities expand CGT capabilities, and include laboratories being updated to accommodate biosafety level-2 (BSL2) work, to maximize space utilization, and to optimize workflows.
“With the strong investments into the CGT sector in the Mid Atlantic (Maryland and Philadelphia) as well as the Northeast (Boston), our Lancaster, PA site is well positioned geographically to support these clients requiring rapid testing services,” says Prince.
Eurofins’ courier system for the Mid Atlantic enables clients to avoid an overnight shipment of material to its Lancaster campus. Eurofins picks up the materials and delivers to its testing laboratories the same day. With open lines of communication between clients and Eurofins, it’s also able to support same day testing initiations. With the advances in autologous cell therapies, Eurofins is also accepting weekend sample deliveries, and are setting up operational personnel and procedures to start testing on weekends to enable clients to bring these medicines to patients in need faster.
“At the Lancaster campus, we built another 168,000 square-foot facility in 2019, which brings the overall campus to 500,000 square-feet, and we are dedicating some of the new space specifically to CGT clients,” says Prince. “Lastly, we are putting many of the CGT specialized testing services in redundant labs within the US as well as our European operations.”
Learn more about Eurofins BioPharma Product Testing’s cell & gene therapy capabilities and investments.
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