Manufacturing

Shortening Timelines and Reducing Headaches by Developing a Clinical Trial Strategy Earlier During Drug Development

This webcast features: Kristen DeVito, Global Director, Clinical Supply Services, Catalent Pharma Solutions Biologic clinical trials can be complex with many factors to consider.  Understanding your specific needs and developing a plan early on during drug development can reduce delays and missteps during clinical trials.  This presentation will discuss: How protocol design can impact clinical supply strategy Which clinical supply variables are most likely to be on the critical path Proactive steps to ensure continuity of supply and reduce the…

Integrated Solutions for Biologics Formulation and Drug Product Development

This webcast features: Dr. Yunsong (Frank) Li, Director of Process Development, Catalent Biologics There are many challenges to conduct thorough drug product formulation development at early stage drug substance process development. Those challenges include material limitation, suitable analytical method, time and labor cost. Sufficient development of the right formulation and dosage form for biologics products early on helps to avoid formulation redevelopment and change during the later stage of product development, which leads to additional analytical, pharmacokinetics or even clinical…

Enabling Success in Biologic Drug Substance Development and Biomanufacturing by Leveraging Expertise and Collaboration

This webcast features: Steven Perry, PE, Senior Director of Manufacturing Sciences, Catalent Biologics Biologic drug substance development and biomanufacturing is a critical step in the long, complex pathway to approval. There are many considerations to be made around cell line and process development, analytical testing and late stage activities such as process characterization and validation. This presentation discusses: Critical drug substance resource needs of sponsor companies How expertise and collaboration amongst the key stakeholders enables successful development and scale up…

Current Analytical Approaches to Biophysical Characterization in a Regulatory Environment

This webcast features: Dr. Anshuman Shukla is Intertek’s Biophysical Characterisation expert at the Center of Excellence for Biopharmaceuticals in Manchester, UK. Structural integrity of protein based therapeutics is one of the major challenges in the biopharmaceutical industry where multiple factors such as the stability, efficacy and shelf life could be affected following minor changes in manufacturing process. This becomes critical particularly with development of more and more biosimilars where comparability to a reference product is required to ensure that the…

Preparing for and Managing Regulatory Inspections

This webcast features: Ray Marzouk, Vice President of Quality at Avid Bioservices Inc. Nothing gets your heart racing faster than receiving a call from your lobby notifying you that a regulatory authority has arrived to perform an inspection. However, with proper preparation and established inspection management protocols in place, navigating a regulatory inspection doesn’t have to be a scary proposition. As a CDMO manufacturing commercial products since 2005, Avid Bioservices Inc. has successfully hosted several regulatory GMP inspections and PAIs…

Improving CHO Cell Biomanufacturing via Whole Genome CRISPR Screening

This webcast features: Jamie Freeman, PhD, Product Manager, Horizon Discovery While Horizon’s GS knockout CHO K1 cell line is rapidly becoming established as one of the best performing cell lines available for the manufacture of biotherapeutics, there is untapped potential within the CHO system. Horizon is focused on using its expertise in genome engineering techniques to modify CHO cell lines to improve their expression capacity for biomanufacturing. Historically, efforts to increase yield have primarily focused on improving media and feed,…

Use of Systematic Tools to Expedite Process Characterization and Maximize Reliability of Process Validation Campaigns

This webcast features: Abel Hastings, Director of Process Sciences, Fujifilm Diosynth Biotechnologies During this webcast you will learn how using a suite of tools, standard practice, and depth of experience in PPQ readiness are aimed at: Effectively focusing attention on critical process understanding and control Scoping and completing the ideal scope and range of characterization Studies to support reliable operations in manufacturing Maximizing reliability during PPQ and commercial manufacturing Enabling full preparedness for PAI and regulatory review   Just fill…

Key Considerations for Advanced Therapies Manufacturing

This webcast features: Thomas Page, PhD, Vice President, Engineering and Asset Development, Fujifilm Diosynth Biotechnologies This technical webinar covers key considerations to support manufacturing activities from the earliest stages of cell line, viral replication platforms and/or viral vectors identification stage leading into clinical production. Having a line of sight into commercial production and the requirements leading into commercial approval are also essential for success. Key messages: Flexibility in conjunction with high containment are key for success Application of closed systems…

Validation of the MycoSeq Mycoplasma Detection Kit for the Release of Veterinary Products

This webcast features: Sébastien Lievyns, Scientist, and Dr. Anne Thomas, Senior Principal Scientist, Analytical Sciences, Zoetis This webcast aims to show how Zoetis has validated the MycoSeq kit for the release of animal products. The Analytical Sciences group at Zoetis confirmed the limit of detection at 10 CFU/mL and good repeatability and intermediate precision of the qualitative mycoplasma qrt-PCR method in presence of these products. For direct PCR performed on vaccine, a background amplification is sometimes observed inducing a signal…

Setting Up a Rapid Mycoplasma Assay Supporting Recombinant Production

This webcast features: Kent Persson, PhD, Project Manager, Octapharma Octapharma AB in Stockholm, Sweden, is the site for the NUWIQ® production, a recombinant human FVIII produced in human cells. Regulatory guidelines states that recombinant bulk harvest need to be tested for mycoplasma prior to further processing. The presentation will give the overview on a nearly completed journey on replacing an out-sourced mycoplasma test with Thermo Fisher’s MycoSEQ qPCR assay. Octapharma in Stockholm has recently been sought regulatory approval for the…