Courtney Morgret, senior scientist, AbbVie Morgret’s presentation focused on antibody–drug conjugate (ADC) manufacturing and ways to accelerate it. She pointed out that ADCs have the potential to be filed for market approval based on phase 2 data. A few such products have been approved and are on the market today, with many more in the pipeline. ADCs provide an opportunity to address unmet medical needs. The task of a CMC (chemistry manufacturing and controls) group is to move a product…
Scott Patterson, vice president of commercial sales, ILC Dover Antibody–drug conjugates (ADCs) are increasing in popularity, with a robust pipeline that could lead to a US$10-billion market over the next several years. These novel treatments combine the high potency of small molecules with the targeting ability of monoclonal antibodies (MAbs). However, the challenge of such treatments is that they combine a highly potent, toxic material with a large protein that will target a treatment area. As a result, manufacturing the…
This webcast features: Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Leachables from single use systems have the potential to impact the quality and safety of your drug product. This presentation will help you understand those risks and how to evaluate them, the current options for test methods and what the future holds so that you can prepare. Key Questions Answered: Why is characterization of Single Use Systems Important? What is the Current State of Methods used…
This webcast features: Roy Sevilla, Senior Manager, Process Development Upstream Group, Avid Bioservices Successful technology transfer is essential to enable rapid manufacturing of biopharmaceuticals for early and late phase clinical supply. When a customer approaches Avid Bioservices to transfer an existing production process, we approach the technology transfer in a structured way involving a cross-functional team from all key functions of the company. This helps ensure the ability to understand and execute against the project requirements, mitigate risks, deliver the…
The dynamics of the biopharmaceutical industry to get innovative products to the client has evolved over the years. Studies have shown that by 2021, biologics and biosimilar products are projected to have higher growth than other pharmaceutical products. Following the industry trend, Avid Bioservices as a Contract Development Manufacturing Organization (CDMO) has helped numerous clients complete their process validations campaigns. Between 2016 to 2019, Avid has successfully completed six. This custom report will share some key factors to consider for…
In past decades, the focus in bioprocess engineering was on traditional stainless steel project management, which is highly dependent on established project schedules. Many milestones, tasks, and deliverables during basic and detailed design and execution were implemented in the same tried and tested way by engineering, suppliers, and biopharmaceutical companies. Making decisions was complicated by alignment with long lead items. With the introduction of single-use (SU) technologies, the transition in execution and optimization of project management only just has been…
This webcast features: Stephen Tottey, PhD, Associate Principal Scientist, Process and Technology Development, Wuxi Advanced Therapies and John Taylor, Process Development Scientist, MilliporeSigma. Clarification of non-settled Lenti suspension harvest can be challenging due to high level of impurities in the feed stream, physical characteristics of the vector, limited filter choices, and low recovery. A series of clarification studies led to the identification of two feasible clarification filter set up options that provide workable outcomes regarding product recovery, impurity reduction, process…
The challenges of multi-national bioprocessing operations are numerous. They include finding highly skilled experts for each site, lack of expertise with single-use systems, contamination risks and redundant efforts and resources—all of which can lead to higher costs. But these challenges also present opportunities for increasing speed to market, eliminating redundant work and overall cost savings. This white paper details the best practices used in global drug manufacturing. The key is global coordination. Best practices and specifications need to be identified…
Long single-stranded RNA oligonucleotides are increasingly necessary for a variety of genomic pathway research and drug discovery studies. However synthesizing and purifying long RNAs can pose unique challenges due to their sequence composition, secondary structure, and applied modifications. Here we explore how Horizon Discovery is leveraging Dharmacon’s 20+ years of RNA synthesis experience to solve the challenges of long RNA oligo synthesis to address unmet research needs.
This webcast features: Carole Langlois, Marketing Manager, Traditional Vaccines, and Marc Hogreve, Senior Engineer Integrity Testing, at Sartorius Stedim Biotech With the expansion of Single Use Systems (SUS) in all process steps of commercial manufacturing, integrity failure can significantly impact drug safety, availability and costs. Consequently, there is an increasing industry scrutiny on single-use container closure integrity (SU CCI), raising the need to develop good science behind liquid leakage and microbial ingress and appropriate physical integrity testing technologies. The presenters…