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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.

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.

Right-first-time custom affinity resin development with unparalleled ligand library diversity

Right-first-time custom affinity resin development with unparalleled ligand library diversity

Traditional approaches to custom affinity resin development often start with a small number of scaffolds, explore limited ligand sequence space and struggle to reach the optimal combination of product specifications. Repligen has resolved these shortcomings by starting the process with >50 multifarious scaffolds and generating unprecedented final ligand library diversity. High binding capacity, selectable pH requirements and caustic stability have been achieved on the first iteration at an unparalleled success rate. Technical features of the development platform, success rate statistics, example performance metrics and economic drivers will be discussed.

Rapid customization of non-metallic totes, carts and clean room workstations fit for purpose

Rapid customization of non-metallic totes, carts and clean room workstations fit for purpose

Mass customization manufacturing methods have been applied to process equipment creating uniquely designed, nearly degradation-free totes, carts, bio-containers, and clean room furniture.  Products constructed from non-metallic materials provide an advantage through easy customization as well as by eliminating degradation seen on stainless steel units when using traditional cleaning products.   Customization benefits and opportunities will be discussed, as well as durability and material benefits of non-metallic plastic solutions.

AAV case study: 3X titer with integrated clarification

AAV case study: 3X titer with integrated clarification

Two case studies illustrate multi-fold upstream AAV titer increases for viral vector from HEK293 cells. In addition to productivity gains, XCell™ and TFDF® technologies clarify conditioned media for manufacturing operational simplicity. Product yield and process economics in the context of the current viral vector supply demand gap will be discussed.

Advanced chromatography system design increases yield and reduces deviations

Advanced chromatography system design increases yield and reduces deviations

The newly designed Artesyn Chromatography Systems from Repligen execute processes with improved yield, reproducibility, and operational simplicity. Over-molded tubing connections eliminate the use of hose barbs and zip ties, which are prone to leaking. Synergistic multi-valve manifolds create a streamlined liquid path without small crevices that typically cause carry-over between buffers. Batch change-overs can be made in under 30 minutes with no tools. The positive impact on process yield and facility output will be discussed.

Configurability, single-use and compliance for with new automated flat sheet TFF up to 500L

Configurability, single-use and compliance for with new automated flat sheet TFF up to 500L

Abstract Driven by the rise in cell and gene therapies, TFF unit operations at scales from 140 mL to 500 L now require the single-use, automation and data integrity capabilities previously reserved for larger scale systems. The newly developed KrosFlo® FS TFF Systems from Repligen provide walk-away automation for multi-step concentration, diafiltration and fed-batch processes with TMP control, closed and single-use flow paths and 21 CFR Part 11 software compliance for processes up to 500 L. Key components to this new system include: a patented automatic back-pressure control valve, a proprietary advanced microprocessor controller that enables plug-and-play hardware connectivity and modern software built upon a secure SQL database. Key technical features and applications supported by flexible configurations of the KrosFlo® FS TFF Systems will be discussed.

Repligen Virtual Seminar | Overcome Bioprocessing Capacity Challenges

Repligen Virtual Seminar | Overcome Bioprocessing Capacity Challenges

Bioprocessing manufacturers are experiencing a surge in demand, and a need for novel solutions that enhance process economics and process optimizations. Led by plenary speaker Prof. J. Christopher Love, topics will include: • Strategic challenges and a vision for on-demand biomanufacturing • Capacity expansion initiatives to meet unprecedented demand • Viral vector manufacturing at scale • Upstream capacity expansion through cell retention based intensification

Configurability and Compliance for Automated TFF up to 500L

Configurability and Compliance for Automated TFF up to 500L

Driven by the rise in cell and gene therapies, TFF unit operations at scales from 10 mL to 500 L now require the single-use, automation and data integrity capabilities previously reserved for larger scale systems. The newly developed KrosFlo® KMPi TFF System from Repligen provides walk-away automation for concentration, diafiltration and fed-batch processes with TMP control, closed and single-use flow paths and 21 CFR Part 11 software compliance for processes up to 500L. Key components to this new system include: a patented automatic back-pressure control valve, a proprietary control board that enables plug-and-play hardware connectivity and modern software built upon a secure SQL database. Key technical features and applications supported by flexible configurations of the KrosFlo® KMPi TFF System will be discussed.