Manufacturing

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…

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…

Shaken, Not Stirred: Rocking Motion Versus Impeller Technology and What is Optimal for Cell Cultivation

This webcast features: Tobias Schenk, PhD, Product Manager, Rocking Motion Bioreactors and Consumables, Manufacturing BT Instruments, Sartorius Stedim Biotech. Cell cultivation might be a laborious process, requiring optimization at various stages to achieve the desired cell densities and satisfactory yields of the final product. Optimization steps can be undertaken by improving cell culture media and buffers, inoculation cell densities, as well as specific cultivation run parameters such as temperature, pH and DO values, or changing the duration of the run…

Small Format Connections for Optimizing Manufacturing

This webcast features: Ray Rendon, Application Development Manager, Colder Products Company. Application Development Manager, Ray Rendon, examines areas for improvement in small format manufacturing processes that are commonly used in cell and gene therapies, sampling, or other small format manufacturing. Optimization of these processes can be achieved with tube welding alternatives like single-use aseptic connectors. In this webinar, you will learn: Key considerations when reviewing your existing processes, such as the total cost of ownership of tube welded connections and…

Streamlined AAV Manufacture: From Plasmid Design to GMP Production

This webcast features: Bo-Jhih Guan, PhD, Senior Scientist, Department of Viral Vector Process and Technology Development, WuXi Advanced Therapies. Adeno-associated virus (AAV) vectors are important gene delivery tools for gene therapies. To ensure that novel treatments can be effective and can reach as many patients as possible, AAV vectors must be produced at high quality and high titres – and manufacturing approaches must keep pace with an increased demand for treatments. AAV quality and titre can be improved by optimizing…

BioProcess Insider State of the Industry – Live from Biotech Week Boston

Ukraine escalation, COVID drop off, cell and gene approvals, and sustainability efforts were the focus of the latest BioProcess Insider State of the Industry discussion at BPI Boston Frank Orlowski, Director of Business Development at Latham Biopharm Group, Miriam Monge, Head of Marketing Fluid Management Technologies at Sartorius, and Joseph Scott, Vice President, Supply Chain at Avid Bioservices, sat down with BioProcess Insider’s Dan Stanton to discuss the geopolitical issues affecting the biomanufacturing space. In front of a full crowd…

Robust Methods for Stability and Identity Testing of Cell and Gene Therapies

This webcast features: Sameer Kalghatgi, PhD, Director of Molecular Biology, WuXi Advanced Therapies. Genetic stability and identity testing are necessary for novel cell and gene therapies to achieve regulatory approval. Sanger Sequencing, human cell line identification using short tandem repeats (STRs) and next generation sequencing (NGS), are important tools for identity and stability testing but must be implemented in a reproducible way. For regulatory approval, the identity and stability of transfected DNA inserts must be confirmed. Sanger Sequencing is widely…

Bioprocess Considerations for Large Scale Transfection

This webcast features: Geddy Hamblen, Field Applications Scientist, Mirus Bio. As demand for viral vectors has grown in recent years, larger production scales are increasingly common. As processes scale, transient transfection must also scale to match. The VirusGEN® family of transfection products, developed by Mirus Bio, has been used successfully at scale in clinical manufacturing and brings unique advantages leading to higher titers and a more robust manufacturing process. In this webinar we will discuss: Challenges and solutions for transfection…