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Leading Biopharma Uses Linkit® AX: Here are the Results

A Leading Biopharma was looking for a way to speed up their CAR-T media preparation. Their manual aliquoting process was time intensive, had a high risk of error and inaccuracy, and lacked a strategy for scaleup to a GMP environment. Sartorius developed a semi-automated media blending and aliquoting solution – the Linki® AX Aliquoting Solution – that has been implemented and is now part of a GMP CAR-T manufacturing process. Read about how they used Linkit® AX to achieve 10x…

The BARDA Industry Day Breakdown

This panel discussion features: Gary Disbrow, PhD, Director, Biomedical Advanced Research and Development Authority; Kristen Herring, PhD, Vice President, The Conafay Group; Ivan Silva, PhD, Principal Consultant, Latham BioPharm Group; Joshua Speidel, PhD, Managing Partner, Latham BioPharm Group; Brian Tse, PhD, Vice President, The Conafay Group. The BARDA Industry Day (BID) Breakdown was a webinar intended to better inform potential BARDA collaborators on the agency’s practices, intentions, and interests. Leveraging the information learned from BID 2022, The Conafay Group (TCG)…

Grow Your CDMO With the Addition of Gloveless, Robotic Aseptic Filling

This webcast features: John Harmer, Strategic Initiatives Leader, Aseptic Filling, Cytiva. Contract development manufacturing organizations (CDMOs) strive to enable clients to get their drug product to patients faster. By expanding their service offerings with aseptic filling capabilities, CDMOs can increase the number and the types of clients they serve. A gloveless, robotic system like the Cytiva SA25 Aseptic Filling Workcell or MicrocellTM Vial Filler helps enable operations to get up and running faster, improve flexibility between products and formats, and…

Residual DNA/Protein and Mycoplasma Detection in Cell and Gene Therapy Products

This webcast features: Hong Li, PhD, Director of Assay Transfer and Validation, WuXi Advanced Therapies. Process-related impurities such as host cell DNA and host cell proteins may have adverse effects on product quality and pose safety concerns for cell and gene therapeutic (CGT) products. These impurities must be removed to the lowest possible level in order to meet regulatory requirements, not only to ensure product safety, but also to help understand the capabilities of the manufacturing process. Therefore, throughout product…

Ensuring Leak-Free Performance During Tissue Container Shipping Utilizing ASTM D4991

This webcast features: Eric Isberg, Vice President, Life Sciences, Savillex. Companies in the fields of tissue engineering and cell therapy find that when standard, off-the-shelf labware containers are used to transport therapies, the container seal can fail during shipment. For a live tissue or cell sample being shipped to a hospital or clinic as part of a treatment, this can be a catastrophic failure that can lead to damaged samples, surgical delays, and poor patient outcomes. When selecting containers for…

DNA to IND in 13 Months: A CMC Strategy for Bispecifics

Multichain protein biotherapeutics such as bispecific molecules have been developed to treat cancer, neurological and ophthalmic disorders, and autoimmune and inflammatory diseases. Early successes now are driving greater numbers of such molecules toward clinical evaluation and commercial approval. However, the complexity of bispecific development and manufacture calls for innovative tools and technologies to facilitate the clinical journeys of such products and prevent costly setbacks for their sponsors. In its commitment to fostering novel biomolecular formats, Lonza has designed a chemistry,…

Intensified Biomanufacturing: Achieving 3-4-Fold Higher Titers of mAbs Using Syngene’s Intensified Fed-Batch Process

Mammalian cell lines are predominantly used to produce mAbs. The current commercial production method uses fed-batch processes that exhibit productivity titers from 1- 5 g/L. Productivity is measured by the volume of products made in each batch. In the fed-batch process, the media and/or feeds are constantly supplied to the bioreactor during the cultivation, where the desired cells produce the product of interest. Productivity variation arises depending on the nature of the antibody and the specific cell line used. Higher…

Drug Development – Developing Biologics for Respiratory Delivery

We bring you an informative on-demand drug development webinar, focusing on developing biologics for respiratory delivery. With drug discovery programmes increasingly focused on biological drug substances for both respiratory and systemic targets, the need to develop effective solutions for nasal and inhaled delivery is becoming increasingly vital for the industry. In this workshop, we will discuss the challenges and solutions alongside examples from real-world projects. Biologic and DNA-based modalities such as oligonucleotides, proteins, antibodies, and a range of other complex…

Benefits of Hollow Fiber Filter Cell Expansion

This webcast features: Stuart Gibb, PhD, Scientific Strategy Lead, Terumo Blood and Cell Technologies. Cell therapy requires cells to be healthy and active throughout the entire manufacturing process for optimal endpoint efficacy. A key part of this process is cell expansion. The Quantum Flex hollow-fiber filter technology provides an effective cell culture environment to provide ready access to fresh media, waste removal, and gas exchange over micrometer distances and works with suspension and adherent cell culture. In this environment, we…

Flexible and Customized Approach to Lentiviral Vector Development and Manufacture Through a Well-Established Platform

This webcast features: Natalia Elizalde, PhD, Business Development/Project Management Director & Rakel Lopez de Maturana, PhD, Qualified Person/Regulatory Director, VIVEbiotech. VIVEbiotech is fully specialized in the development and GMP manufacture of lentiviral vectors along EMA and FDA requirements. Having worked for more than 35 international biotech and pharma companies since 2015, VIVEbiotech has developed its service approach in a customer-centric manner, so that all our activities are developed to satisfy the real requirements of our partners. In this webinar, VIVEbiotech…