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Enabling Large-Scale Production of Viral Vectors in the Gibco™ CTS LV-MAX Lentiviral Production System

This webcast features: Jonathan Zmuda, PhD, Director, Cell Biology, Life Science Solutions Group, Thermo Fisher Scientific The Gibco™ Cell Therapy Systems (CTS™) LV-MAX™ Lentiviral Production System enables scalable, high-titer production of lentiviral vectors using HEK293F-derived Gibco™ CTS™ Viral Production Cells adapted for high-density suspension growth in chemically defined, serum-free, and protein-free Gibco™ CTS™ LV-MAX™ Production Medium. Enhanced lentiviral production is enabled through the synergistic interplay of the LV-MAX components (including cells, production medium, supplement, enhancer, and transfection reagent), all of…

Single-Use Technologies: Innovation and Performance

The biotherapeutic market has been rapidly adopting single-use technologies to reduce risk and improve operational efficiencies. For more than 20 years, Thermo Fisher Scientific has pioneered single-use technologies for this industry. Our products have been proven to be robust and scalable from laboratory scale-up to current good manufacturing practice (cGMP) production applications, including single-use bioprocessing equipment, flexible containment, and rigid containment product portfolios. Our webinars will explore data, innovative products, and novel strategies featuring single-use solutions for the bioprocessing market.…

Breaking the Bottlenecks: Accelerating Viral Vector Bioanalysis in Downstream Processing

The rise in popularity of viral-vector–based gene therapies and SARS-CoV-2 vaccines has created a shortage of manufacturing capacity, driving efficiency improvements to avoid bottlenecks in bioanalysis to support culture optimization and bioprocessing steps. To improve workflows in bioanalytical assay development and sample analysis, more efficient methods are needed that include higher throughput, simpler and more streamlined sample assay methods, wide dynamic ranges, and efficient data processing and interpretation. Gyrolab™ microfluidic, nanoliter-scale immunoassay systems provide an innovative, robust solution to high-performance…

A Smart Path for Novel Biologics

Roche Pharma Research and Early Development (pRED) was faced with a challenge: double the number of projects in process development without significantly increasing headcount. Pawel Linke, a pRED lab automation specialist, tells the story of how the group approached this challenge with a focus on obtaining high quality data through automation and by integrating independent lab systems and devices to streamline their workflow. Implementation of high-throughput process development systems requires an orchestrated approach of both hardware and software solutions, so…

Embedding Your Drug Strategy Within a Solid Foundation for Success

Demand for drugs and therapeutics is growing thanks to the globalization of pharmaceutical-based medicine. Manufacturing new drugs and getting them to market faster, more economically and safely demands development strategies and business models that support successful outcomes for both investors and patients. Outsourcing has become an increasingly attractive business model for pharma as companies seek partners who can deliver comprehensive end-to-end drug substance and drug product development. It has prompted contract manufacturing organizations (CMOs) to consolidate and expand to create…

Peptide Therapies: Designing a Science-Led Strategic Quality Control Program

Peptide therapeutics are a unique class of pharmaceuticals. They can fall into one or more regulatory categories: as conventional chemical molecules, biological entities, or biosimilars. Developing a well–thought-out quality control (QC) strategy is key to meeting development milestones and complying with evolving regulatory requirements. Safety assessment is critical because slight changes in the structure, physicochemical properties, stability, and impurity profile of a peptide can provoke an adverse immune response. A robust analytical QC program should be conducted in laboratories that…

PendoTECH looks to compact photometer for post-filtration turbidity measurements

PendoTECH has upgraded its single use turbidity measurement system to improve performance, dynamic range, and overall usability Turbidity is the relative clarity of a liquid as the result of suspended solids in the liquid. Turbidity measurements typically use a beam of light to detect the presence of particles by measuring the difference between the amount of light that is emitted from a light source and the amount that is received by a detector. Measurements are affected by the size, shape,…

Efficient and Rapid Purification of E. coli Expressed Toxin Recombinant Protein Fragments

This webcast features: Andrew Lees, PhD, Founder and Scientific Director, Fina Biosolutions, LLC Tetanus toxoid (TT) is frequently used as a carrier protein for conjugate vaccines. TT contains strong T cell epitopes. They are toxoided protein and are not a uniform product because of specific toxoiding and purification processes. TT tends to aggregate with age and is not affordable to produce in quantities for research and early clinical work. TT heavy chain fragment C (rTTHc) is the C terminal fragment…

Manufacture of CRISPR RNPs for Clinical Use

Shawn Shafer, PhD, genome editing platform lead, Aldevron Shafer spoke about manufacturing ribonucleoproteins (RNPs) for clustered regularly interspaced short palindromic repeats (CRISPR) for clinical applications. CRISPR RNP consists of a guide RNA (sgRNA) complex with the CRISPR-associated protein 9 (Cas9). The Cas9 protein is complexed with the guide RNA as it associates with the genomic DNA. Once the guide RNA is aligned with the complementary genomic DNA sequence, the catalytic nucleus domains cleave the genomic DNA, creating a double-stranded break…

Technology Integrators in Cell and Gene Therapy: Powering Innovation

Julien Meissonnier, vice president and chief scientific officer, Catalent Meissonnier shared information about the expanded role of contract development and manufacturing organizations (CDMOs) in cell and gene therapies (CGTs). Catalent entered the gene therapy space in 2019 through acquisition of Paragon BioServices, adding expertise in adenoassociated viruses (AAVs) and viral vector manufacturing. Cell therapy capabilities were acquired early in 2020 through acquisition of MaSTherCell, with the goal of providing end-to-end integrated solutions to CGT customers. In addition to expertise in…