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Improving Titer, Quality and Efficiency of AAV Manufacturing and Production by Optimizing Osmolality

The rate of innovation within Cell and Gene Therapy is incredible and will continue to grow at an exponential rate as new methodologies are developed. With the novel techniques, come new and improved manufacturing procedures for sought after therapies. The use of viral vectors is now a common approach within the sector, but there are still difficulties when scaling up for bioprocessing. An example being a recovery range of 5-30%, a less than optimal result within the manufacturing process. When…

Designing a Plasmid DNA Downstream Purification Process

mRNA plasmid-based DNA vaccines, and advanced modalities using viral vectors, are at the forefront of the fight against cancer, cardiovascular, immunological, and infectious diseases. To reach their full potential and benefit as many patients as possible, however, workflows used for their manufacture must achieve greater efficiency. A critical step in the process is production of plasmid DNA (pDNA), which traditionally, delivers low yields and requires complex purification schemes. This new process development book provides you with guidance for your plasmid…

Innovations in Single-Use Technology Help Advance Downstream Processing

Biopharmaceutical manufacturers across the globe are trying to rapidly expand their production capacity to meet the growing demand for new therapies. A key challenge they face is to scale that expansion cost-effectively while protecting the quality and integrity of their production processes. One way they are achieving this growth is through expanded use of single-use systems (SUS). This informative new Avantor® Technical Article details several ways SUS technology can help improve throughput and productivity in key downstream processes that routinely…

Best Practices for Oncolytic Virus Design, Development, and Manufacturing

Oncolytic viruses (OVs) have the potential to become a very important pillar in the treatment of cancer because of their dual mechanism killing infected cancer cells and triggering anticancer immune response to also destroy uninfected cancer cells. This motivates researchers continually optimize oncolytic viral vectors to further improve their safety, efficacy as well as manufacturability for a commercial scale-up. As biopharmaceutical manufactures just begin to explore the prospect of OVs based therapies, the need for contract development and manufacturing organizations…

Downstream Process Development for the Purification of Biosimilar Insulin from Escherichia Coli

This webcast features: Sharon Bola, Global Product Manager, Process Chromatography, Bio-Rad Laboratories. With the increasing global demand for insulin product, there is a need to develop a more efficient and economical process for the production of recombinant insulin therapeutics. In this webcast, we will present an efficient downstream processing workflow for recombinant human insulin production using Escherichia Coli as the host system. Data will be presented for sample preparation and purification results of proinsulin and insulin. Size exclusion was identified…

Building and demonstrating quality of mAb therapies from the ground up

The demand for monoclonal antibody (mAb) therapies is growing at an unprecedented rate likely due to their proven effectiveness in treating a wide range of illnesses. The recent pandemic is just one example of a situation where the potential of mAbs to reverse even the most severe disease was realized. This bodes well for mAb biosimilar manufacturers ready to bring many more products to market over the next decade. Public impact MAbs had a significant head start over novel technologies…

Robust and Scalable MAb Capture Facilitated by a Novel Convecdiff Membrane Structure

Alternative stationary phases are being developed to solve the shortcomings of bead chromatography processes, namely high diffusional resistance leading to long processing cycles (4–6 h). Targeted lifetimes of 75–150 bind and elute cycles, taking sometimes years to achieve and requiring cleaning and respective validation, storage, and column unpacking and repacking, elevate costs and introduce increasingly unacceptable bioburden risks. Chromatographic membranes, due to intrinsically high mass transfer rates, overcome these limitations, enabling residence times of seconds and full lifetime utilization (75–150…

Comprehensive Solutions for Your Vaccine Platforms

You want to scale and deliver your vaccine to the world quickly. Our collaborative global vaccine capabilities will take your innovation from pre-clinical to full-scale GMP-manufacturing efficiently, safely, and cost-effectively. Our new handbook describes how our global capabilities can help you achieve these goals for all your modalities/platforms including inactivated/live attenuated vaccines, subunit vaccines, VLP vaccines, viral vector vaccines, pDNA vaccines, mRNA vaccines.

Flexibility in Next-Generation Facilities Through Rocking Motion Bioreactors

The biopharma industry continues to face increased demands for more efficient production processes and flexible solutions. Increasing efficiency in upstream bioprocesses leads to improvements in yield, speed, and cost-effectiveness. However, an often-overlooked feature of intensifying production processes is how they contribute to a more flexible and streamlined process, essential to meet the demands of this dynamic industry. What you will learn: Understand the issues creating operational challenges for the biopharma industry. Explore how an intensified seed train can increase upstream…

Leveraging Post-Translational Modifications and Bio-Functional Assays for Characterization of Charged Variants

This webcast features: Shawn Fitzgibbons, Senior Manager & Jacob Kraus, Manager, Biologics Analytical, Catalent. The heterogeneity of a biologic product has implications for the safety and efficacy of the final biotherapeutic or biosimilar therapy. It is important to characterize the charged variant profiles of biologics, since many important post-translational modifications (PTMs) impart or alter the charge (isoelectric point or pI) of the molecule, potentially impacting stability, pharmacokinetics, and pharmacodynamics. Examples of charged variants include lysine variants and deamidation products, both…