Ask the Experts

Advantages of Custom Chromatography Resin Development: A Viable Solution for Purification of Complex Biotherapeutics

This webcast features: Scott Zobbi, Senior Manager of Business Development, Custom POROS Resins, Thermo Fisher Scientific Advances in biotherapeutic development are generating an increasing range of complex molecules, often presenting unique and complex purification challenges. Addressing these challenges requires novel purification strategies for commercial manufacturing, which may not always exist. When your specific process needs cannot be met with off-the-shelf resins, custom resin production may be a viable solution. Our POROS™ custom resin and CaptureSelect™ custom affinity matrix development platforms…

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…

Ask the Expert: Emerging Trends in Drug Assembly and Packaging

Thomas Gabriel (director of strategy and business development at Fujifilm Diosynth Biotechnologies, FDB) emphasized patient agency in his 15 April 2020 “Ask the Expert” presentation on innovations in finished-goods solutions. Facilitating self-administration significantly benefits patients with chronic conditions, and new delivery technologies are making drug products increasingly easy to handle and with increasingly accurate dosing. Gabriel explored how single-use autoinjectors and prefilled syringes, needle shields, on-body delivery systems, and digital monitors are improving drug-delivery safety and efficacy while enabling patients…

Ask the Expert: Improving Host-Cell Protein Detection By Enriching Mass Spectrometry Samples

Enzyme-linked immunosorbent assays (ELISAs) remain the industry standard for process monitoring and lot-release testing for host-cell proteins (HCPs), but researchers need orthogonal tests to confirm that an ELISA is fit for purpose. On 22 April 2020, Eric Bishop (vice president of research and development at Cygnus Technologies) delivered an “Ask the Expert” presentation about his company’s solution: mass spectrometry (MS) preceded by a novel Antibody Affinity Extraction (AAE) technique. Bishop explained that an AAE step can magnify a sample’s HCP…

2.5× Lentiviral Vector Bioreactor Yield Increase and Simplified Execution with Innovative Tangential-Flow Depth Filtration

This webcast features: Michael Bransby, R&D Director of Process Technology, Repligen In a joint collaboration, Oxford Biomedica and Repligen increased the yield of viral vectors from suspension-cultured bioreactors several fold using tangential-flow depth filtration (TFDF). The yield for a single clarification step was 95% as compared to 70% by standard depth filtration. The TFDF tubular format and low shear enabled further yield increases through multiple harvests from the same seeding. A single seeded bioreactor produced two harvests of 95% and…

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…

Protein A Chromatography: Using Automation Instead of Multiple Columns To Increase Productivity

This webcast features: Van Leang, Senior Director of Global CMC Operations, HJB Bio Vendors supporting biologics manufacturing are developing equipment to enable continuous process in downstream operations. Using continuous downstream operations reduces operational time and raw material costs. HJB has developed a downstream hybrid process that uses an automated batch approach to achieve a continuous downstream capture process. This allows the use of the current monoclonal antibody (MAb) capture platform but reduces cost overall by adopting the benefits of continuous…

Technology-Ready Processes for Gene Therapy Manufacturing 2.0

This webcast features: René Gantier, PhD, Director of Technology, Gene Therapy, Repligen The current manufacturing processes for viral vectors for gene therapy, which we can define as Gene Therapy Manufacturing 1.0 (e.g., adherent cell culture and transient expression from plasmid transfection), are not productive enough to meet the future demand considering the quickly increasing number of approved gene therapies and clinical trials. A transition is therefore ongoing to implement more productive and scalable processes, leading to Gene Therapy Manufacturing 2.0 using…