Leveraging Instrumentation to Accelerate Release Testing & Minimize Human Input

This talk will focus on the analytical testing needed for the release of cell and gene therapy products. A lot of focus has been on improvements and automation of equipment used in manufacturing of cell therapies such as bioreactors. However, to improve and speed up the release testing, this needs to be done also on the analytical side.

Today, in most Quality Control labs, the instruments and methods that are used for in-process and release testing are high throughput (bigger sized instruments) and require experienced analysts for the execution of the test, for example in flow cytometry. The preparation of the sample involves manual manipulation, such as for the potency assay, sometimes very extensive and lengthy before ready to be tested. Once the test is performed, the data needs to be analyzed and calculated for the reportable results, it may for example be from an ELISA for cytokines or the genetic transduction by PCR. The entire procedure from the sample preparation to the data analysis for the results provides opportunities for errors, and the manipulation of the samples can have an impact on the cells. This may decrease the precision of the assay and potentially cause Out Of Specification and delay of product release. 

Depending on each specific product, different analytical tests and assays are required for the release of the product. However, safety tests for determination of absence of mycoplasma, endotoxin, and bacterial and fungal contamination are mandatory for all products. No matter the type of tests or assays, there is a need for faster and less hands-on technology.  Using automated instruments and methods with less manipulation of the sample and automated data analysis, offers opportunities to reduce time and costs for the release testing, as well as providing assays with improved performance and less prone for errors.

Presented by Therese Choquette, PhD. Head of Analytical and Translational Sciences at Tigen Pharma

With extensive experience in Cell Therapy and Analytical Development, Therese Choquette has been involved in every stage from early development to commercialization. At Novartis, she led the development of potency assays for the groundbreaking CAR-T product Kymriah, and she later transitioned to the role of analytical project leader. Following, she joined Janssen Pharmaceuticals as an Analytical Scientific Integrator, specializing in vaccines and cell therapy products. Later, she became the Director for Global QC at Iovance Biotherapeutics, focusing on TIL therapy. Currently, she is the Head of Analytical and Translational Sciences at Tigen Pharma focusing on autologous T-cell therapy products in early development. As a former Licensed Practical Nurse, her passion lies in providing high-quality cell therapies to patients. She constantly seeks to understand what makes a cell therapy product of the highest quality and strives to implement the best analytical methods for achieving this. In addition, she strives to develop release assays that require minimal manipulation and utilizes automated instruments for both assay execution and analysis.  During her PhD project and post-doc, her research focused on immune cells from both humans and mice, studying impact on the immune system from B-cell depletion by Rituximab in patients with lupus and impact of hyperglycemia in mice on host defense against Mycobacterium tuberculosis.

Next Generation in vitro Potency Assays: Advancing CGT Development With Real-time, Label-free Impedance and Imaging Technologies

Presented by Zhong Yu, Senior. Business Development Manager at Axion BioSystems

Zhong Yu is an experts in biotech with a strong focus on immuno-oncology, cancer and business development. As Senior Business Development Manager at Axion BioSystems, Zhong spearheads growth initiatives and builds strategic partnerships in cutting-edge life sciences. Previously, as Scientific Liaisons Manager, she played a key role in bridging scientific innovations with market opportunities. With over a decade of experience, including roles like Sr. Global Product Manager at LUMICKS and Global Product Manager at Miltenyi Biotec, Zhong has deep expertise in immuno-oncology, product strategy and development, and market expansion. Armed with a PhD in Molecular Microbiology from Vrije Universiteit Amsterdam, the Netherlands she combines scientific insight with proven business acumen, making her a driving force in advancing biotech innovations globally.

Leveraging Robotic Systems to Increase Accuracy, Precision, and Reliability in Endotoxin Detection

Presented by Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza

Allen L. Burgenson has over 35 years of experience in industries regulated by the FDA, including foods, drugs, biologics, medical devices, and cosmetics. He has worked in R&D, QC, QA, regulatory affairs, and now marketing as an SME for endotoxin detection. Allen is involved in several scientific organizations, including the immediate past chair of the Horseshoe Crab Advisory Panel for the Atlantic States Marine Fisheries Commission (ASMFC) and the immediate past president of the Capital Area Chapter of the Parenteral Drug Association (PDA). He was Chair of the 2004 PDA Annual Meeting.  He is a co-author of three PDA technical reports, including, TR-50 and 51 regarding mycoplasma detection and filtration and TR-82 regarding Low Endotoxin Recovery (LER). Allen also contributed to USP Informational Chapter <1228.5> on Endotoxin Indicators. Allen has a BA in Microbiology from Rutgers University and an MS in Biotechnology Management from the University of Maryland

One-hour Automated Mycoplasma test for Cell and Gene Therapy products using a Molecular lab-in-a-pouch system

Presented by Félix Montero-Julian, Scientific Director of Pharma Quality Control at bioMérieux

Félix is the Scientific Director of Pharma Quality Control at bioMérieux. Félix has over 25 years of experience in industrial and clinical diagnostics and previously served as the Chemunex R&D Director at bioMérieux. Félix graduated from the Autonomous Metropolitan University in Mexico as an Industrial Biochemistry Engineer and holds a Masters in Science and a PhD in Immunology from the Aix Marseille II University in France. Félix is a member of different scientific organizations (PDA, ISAC) and served as an expert in a panel for the development of compendial rapid sterility tests for the USP. Félix has been and continues to be extensively involved in the implementation and acceptance of rapid and alternative microbiological methods. He has authored more than 50 scientific publications in basic and applied immunology and microbiology and is an inventor of more than 6 patents on immune therapeutic approaches. He is a prominent speaker at congresses and conferences and a regular contributor to bioMérieux scientific whitepapers. Félix has extensive technical experience, including the development of in vitro diagnostic and research reagents and applications, cell and tissue culture systems, microbiology, alternative and rapid microbiological methods, sterility testing, mycoplasma detection, compendial methods, methods for blood bank testing, and the cell and gene therapy process.

Sponsored by Axion BioSystems, Lonza and bioMérieux

About Axion BioSystems

Axion BioSystems is a leading life science tools company focused on innovative live-cell assay platforms to study the in vitro function of cells for drug discovery, disease modeling, cancer immunotherapy, safety/toxicity, and more. Our Maestro platform allows you to track growth and death kinetics of cancer cells or monitor intricate, electrical activity of excitable cells with label-free MEA and impedance measurements. The Omni live-cell imaging product line combines compact, fast imaging hardware with powerful image analysis software. Axion’s award-winning products are designed to accelerate scientific breakthroughs and transform therapeutic development from discovery to manufacturing.

About Lonza

Lonza is the preferred global partner for the pharmaceutical, biotech, and nutrition markets. We focus on enabling treatments that prevent illness and support healthier lifestyles. We optimize scientific innovation and manufacturing technology to enable our customers to serve their patients and consumers. Our comprehensive range of testing solutions supports your efforts in pyrogen and endotoxin testing of raw materials, in-process samples, and manufactured products.

No matter where you are in your process, Lonza’s testing products optimized with our world-class software and hardware solutions and supported by our experts will help streamline your workflows and meet regulatory requirements for injectable drugs and implantable medical devices, including for new modalities used in modern vaccines and biologics. We can help answer your questions about endotoxin testing, whether you use qualitative gel clot, quantitative turbidimetric, or quantitative chromogenic LAL-based assays, or want sustainable recombinant factor C endotoxin testing or sustainable pyrogen testing.

Our BioScience Division provides a large portfolio of testing solutions to support the pharmaceutical and medical device industries, including classical LAL assays (Pyrogent® gel clot, Pyrogent-5000® kinetic turbidimetric, and KineticQCL® kinetic chromogenic assays) and sustainable recombinant Factor C (PyroGene®) assays for endotoxin detection.  We provide monocyte activation assays to detect pyrogenic substances as a sustainable alternative to the Rabbit Pyrogen Test.  We also supply the industry-leading MODA software for laboratory data that eliminates paper from the process, as well as the PyroTec^TM PRO Automated Endotoxin Testing solution, which is the industry leader in automated endotoxin detection.

About bioMérieux – Pharma Quality Control

With a partner-first approach to Pharmaceutical Quality Control, our experts deliver an integrated offer that easily adapts to your our facilities, products, and processes, to ultimately provide critical therapies to patients quickly and safely. Our suite of innovative solutions provides rapid, highly accurate methods to reduce risk, boost operations efficiency, facilitate regulatory compliance, and empower smarter, data driven decision-making.

Guided by our ​public health purpose,​ we help the pharmaceutical industry learn and adapt, to keep up with the rapidly changing environment, leading to shifting and emerging risks, by anticipating regulatory and scientific evolutions ​and heavily investing in new sciences and analytical technologies​.​

Rooted in more than 30 years of innovation ​and guided by our pioneering spirit, ​we help increase pharmaceutical products’ quality to ultimately provide the best possible healthcare conditions across the world.​

Your Ally in Advancing Quality.​