Manufacturing

Strategic Development of Characterization and Quality Control Programs for Therapeutic Peptides

This webcast features: Ashleigh Wake, UK Business Development Director, Intertek Pharmaceutical Services Peptide therapeutics are a unique class of pharmaceuticals that may be regarded, in regulatory terms, as either conventional chemical molecules, biological entities or biosimilars. Slight changes in the structure, physicochemical properties, stability, and impurity profile of a peptide can provoke an adverse immune response; therefore, safety assessment is critical. Building a well-thought-out quality control (QC) strategy is key to meeting development milestones and complying with evolving regulatory requirements.…

Application-Specific Enhancements to Thermo Fisher Scientific™ HyPerforma™ Single-Use Bioreactors

This webcast features: Ben Madsen, Engineer, Thermo Fisher Scientific The rapid growth of biotherapeutic manufacturing has created significant demand for workflow solutions featuring greater product yield, lower production costs, and accelerated development timelines. To address these demands, developers have moved away from “one-size-fits-all” approaches and are increasingly focused on solutions that address the specific needs of diverse bioproduction processes. Given this shift toward process-specific solutions, Thermo Fisher Scientific™ has introduced a series of application-specific enhancements to the HyPerforma™ Single Use…

Cell Culture Media Manufacturing, Outsourcing and the Pandemic: An Essential Toolkit

This webcast features: Chad Schwartz, Senior Global Product Manager for Proprietary Cell Culture Media Formulations, and  Eric Nalbach, Director of Product Management, Bioproduction, Cell Culture Media, Thermo Fisher Scientific The COVID-19 pandemic has had an unprecedented impact across the bioproduction industry, from supply chains to working practices. As organizations adapt to such changes, they have already experienced huge shifts in how the industry works. Those working in both research and manufacturing feel an obligation to employ all available resources to…

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…

Viral Vector Empty Versus Full and Plasmid Quantitation Analytics for Accelerated Gene Therapy Time to Market

This webcast features: Joe Ferraiolo, Associate Director, Bioanalytics Applications, C Technologies, a Repligen Company Analytical technologies play a crucial role in accelerating gene therapy speed to market. Dilution steps during protein and DNA quantitation measurements represent the single highest source of accuracy and precision errors. The SoloVPE® device provides a dilution-free workflow that saves time, reduces deviations, and facilitates multisite alignment. Multiple case studies from major biopharmaceutical companies describe execution in process development, analytical labs, and directly on good manufacturing…

Figure Out Any Particle with Automated Counting, Sizing, Morphology, and Identification Using the Hound

This webcast features: Lisa Krapf, Field Automation Scientist, Unchained Labs Thorough particle sizing and analysis are essential steps in formulation development and the monitoring of manufacturing process controls. Traditional particle analysis techniques such as light obscuration do not provide morphological information that can be useful for classification. Transfer to manufacturing and scaling to production will necessitate different equipment and the potential introduction of extrinsic particles that may not have been observed previously. The combination of particle analysis with flexible options…

Protein or Not? Advanced High-Throughput Aggregate Analysis with the Aura™

This webcast features: Bernardo Cordovez, Chief Science Officer and Founder, Halo Labs In protein-based formulations, distinguishing aggregated active pharmaceutical ingredient (API) from other particle types is important for understanding the root cause of instability. Until now, existing methods have been either unreliable or too cumbersome to use in many workflows. Here we introduce the Aura™ 96-well low-volume aggregate and particle imaging system, which can rapidly size, count, and characterize particles and identify them as proteins, non-proteins, hydrophobic, or other types…

Translating Inhaled and Nasal Technologies for the Delivery of Biologics

This webcast features: Mark Parry, Technical Director, Intertek Inhaled and nasal delivery platforms have specific applications outside of their traditional uses for asthma/chronic obstructive pulmonary disease (COPD) and seasonal rhinitis/sinusitis: They can offer real advantages for the delivery of therapeutic biologics. During this short presentation, Intertek’s Technical Director, Mark Parry, will provide an overview of currently available technologies and successfully marketed products, with a look at the development challenges that might be encountered — and the solutions that are available…

Relative and Absolute Quantitation of Impurities and HCPs Using Mass Spectrometry

This webcast features: Steven Broome, Senior Mass Spectrometrist, BioPharmaSpec The processes involved in manufacturing a biopharmaceutical use biological and chemical systems to produce and purify the drug product. Therefore, the final active pharmaceutical ingredient (API) will often contain impurities related to these processes. It is a regulatory requirement to identify and monitor process-related impurities, and a qualitative and quantitative assessment of the components in the final drug product must be performed. Knowledge of the product-specific impurities, such as host-cell proteins…

Optimizing Your Excipient Screening for Vaccine Formulation with an Ultra-Pure Pharmaceutical Gelatin

This webcast features: Jeroen Geeraerts, Business Development Manager, Biomedical, Rousselot The world is working at an unprecedented pace to develop a safe and effective vaccine to combat the COVID-19 pandemic. Currently, five candidate vaccines are in clinical evaluation, and many more are in preclinical testing. Different types of vaccines are being developed using multiple strategies and platforms. Among them are several inactivated-virus and live-attenuated–virus candidate vaccines. As an excipient, gelatin is a key component in many vaccine formulations. Well-known examples…