You are using an unsupported browser.
Some features of this site may not function properly. For optimal user experience, please view this site in Chrome, Firefox, Safari, or Edge.

Videos

Featured Video

Repligen Solutions from Gene to Therapy

Gene Therapy has immense potential to transform the lives of patients with genetic diseases. As demand for plasmids and viral vectors outpace capacity, a greater than 10-fold and potentially close to 100-fold increase in manufacturing efficiency for the gene therapy reagents is likely required to meet a demand curve that is increasing exponentially. Repligen solutions aim to meet the needs for optimized processes, higher yields, and improved process quality - setting new standards for modern scalable processes from gene to therapy.

Viral vector N-1 intensification reduces seed train vessel number, media volume and time

Viral vector N-1 intensification reduces seed train vessel number, media volume and time

The demand for gene therapy viral vectors requires manufacturing processes to scale up to 2000 L. Viral vector production at this scale requires a 9- to 12-day seed train with two to three seeding bioreactors, increasing the risk of failure and manufacturing cost. Perfusion-based cell culture intensification techniques shorten and simplify the seed train for recombinant proteins and monoclonal antibodies production by reducing time, equipment, bioreactor size and cost while increasing the potential number of batches per year. This webinar will discuss similar efficiency gains for three different viral vectors (lentivirus, AAV8 and AAV9) through intensification using KrosFlo® TFDF® Technology that resulted in reduce train vessel number, N-1 vessel size, media volume and time.

Where and When to Apply Upstream Process Intensficiation Technologies

Where and When to Apply Upstream Process Intensficiation Technologies

Biopharmaceutical process intensification may be applied to multiple points in the workflow to increase productivity by orders of magnitude for diverse modalities, including recombinant proteins, vaccines, cell therapies, plasmid DNA and cultured meat. This webinar describes application of XCell ATF® Technology to the seed train and the production (N) bioreactor in different modes to create time, cost and facility efficiencies. 15+ years of published application data, implementation in the largest number of commercial processes and proven scaling from 1 L to 5000 L differentiate XCell ATF® Technology from all other upstream intensification methods. Considerations for when and why to apply XCell ATF® Technology in order to meet specific productivity goals will be discussed.

Advanced affinity chromatography platforms for gene therapies and vaccine responses

Advanced affinity chromatography platforms for gene therapies and vaccine responses

The first and only NaOH-cleanable affinity resins for AAV2, AAV8 and AAV9 have been developed using a breakthrough development platform based on unprecedented ligand diversity. Performance metrics for capacity, yield and purity meet or exceed existing AAV resins while also withstanding more than 20 CIP cycles with 0.5 M NaOH. Off-the-shelf resin availability pre-packed in OPUS® Columns, as well as loose resin, enables streamlined implementation. The technical basis of the development platform and example data will be discussed.

Case study: Increasing AAV recovery with new chromatography system technologies

Case study: Increasing AAV recovery with new chromatography system technologies

The growing complexity of new modalities is raising the expectations of single-use chromatography technology. The traditional systems still  in use however present dozens of built-in challenges all along the flow path. Decades of drive, development,  and attention to every detail allowed us to turn these challenges into higher recovery, maintained bioactivity and mitigated risk. This talk takes you from a system in the back of a sprinter van into the  facilities of the future. Unique technologies of the systems platform that support higher the increased process efficiency will be discussed in detail. Case studies on the application of these technologies to increasing AAV recovery and analyzing graadient control will also be addressed.

Key Milestones that Defined Modern Upstream Intensification Standards

Key Milestones that Defined Modern Upstream Intensification Standards

Upstream bioprocess intensification has evolved over the past 20 years from an idea to a mature approach that has increased productivity by orders of magnitude and viable cell densities (VCD) in excess of 200 X 106 cell/mL. This webinar will walk through the key technical milestones achieved by the XCell ATF® technology over that span, providing a concise historical summary and definition of modern upstream intensification standards. Focus areas include controller and XCell ATF® advancements, transition to single-use, application extensions and key industry trends. While CHO cell lines expressing recombinant proteins remain the most common process, emerging applications include cultivated meat, cell therapies, animal vaccines, and plasmid DNA. Wholistic consideration of cell types, modalities, and scale-up from process development to manufacturing will provide context for the past, present and future of upstream intensification.

Upstream Process Intensification for Virus Vaccine Manufacturing Case Study

Upstream Process Intensification for Virus Vaccine Manufacturing Case Study

Many viral manufacturing processes for animal health have been transferred from the time consuming and higher risk adherent culture systems to more scalable suspension cell cultures. Growing demand and the need for efficient and economic processes drive the continuous search for innovations. This talk describes studies conducted at MSD Animal Health to evaluate the XCell ATF® Technology for intensification of virus propagation on suspension cells.

Chromatography system redesigned: Engineered for superior recovery, bioactivity and risk mitigation

Chromatography system redesigned: Engineered for superior recovery, bioactivity and risk mitigation

Abstract The gene therapy era has brought with it a new set of chromatography yield and operational challenges. Over-molded tubing connections and near dead-leg free valve blocks reduce turbulence, preserving gradient integrity before the column and peak to peak resolution after the column. Quattroflow® pumps and flow path optimization can abate shear stress and increase bioactivity. For set-up, connect closed and sterile pre-assembled kits with 3 AseptiQuik® connections and install in less then 30 minutes with no tools and no wizard. A case study on the positive impact on process yield and output will be discussed.

Introducing NaOH-stable AAV affinity resins: the first chapter of a growing catalog

Introducing NaOH-stable AAV affinity resins: the first chapter of a growing catalog

The first and only NaOH-cleanable affinity resins for AAV2, AAV8 and AAV9 have been developed using a breakthrough development platform based on unprecedented ligand diversity. Performance metrics for capacity, yield and purity meet or exceed existing AAV resins while also withstanding more than 20 CIP cycles with 0.5 M NaOH. Off-the-shelf resin availability pre-packed in OPUS® Columns, as well as loose resin, enables streamlined implementation. The technical basis of the development platform and example data will be discussed.

Realization of PAT inline using variable pathlength spectroscopy - applications in downstream mAbs and viral vector purification

Realization of PAT inline using variable pathlength spectroscopy - applications in downstream mAbs and viral vector purification

The first and only variable pathlength analysis technology has been integrated in-line with flow paths for PAT use in downstream unit operations. Rapid and accurate real-time results were acquired on the widest range of samples and concentrations (from less than 1 mg/mL to over 300 mg/mL), revealing previously unrecognized process characteristics.