Downstream Processing

Dual-Chamber Syringes vs. Vials

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Is there a clear choice between dual-chamber syringes and vials in today’s competitive drug development market? That’s the topic of this recorded webcast. During the webcast, the speakers address the following questions: What are the causative factors that have resulted in the rapid increase in prefilled syringes over the last several years? Do dual-chamber syringes offer distinct advantages over vials in drug development? How can dual-chamber technology help differentiate products in a highly competitive environment? What are the main differences…

August 26, 2014
Clinical Syringe Development Webinar

Clinical Syringe Development: An Innovative Approach to Gain an Early Advantage

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Do ever-rising drug development costs, highly competitive markets, and increasing regulatory demands sound familiar? This webcast addresses the benefits of starting syringe work earlier in the development process of injectables. This webcast will: Provide an overview of the many development challenges faced by pharmaceutical and biotechnology companies Discuss the benefits of clinical syringe development including time savings and package attractiveness Offer a case study with a live question and answer session Feature thought leaders Dr. David Brett and Dr. Sabine…

August 26, 2014

Evaluation of HCP and DNA Clearance with NatriFloâ„¢ HD-Q Membrane Adsorbers at Lab to Process Scales

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NatriFloâ„¢ HD-Q chromatography from Natrix Separations introduces reliable and reproducible Q polish performance that combines resin binding capacity with adsorber speed to achieve a new level of process flexibility. Gallus Biopharmaceuticals (a St. Louis based CMO) evaluated NatriFloâ„¢ HD-Q membrane columns as an anion exchange polishing step with the objective of assessing NatriFlo’s ability to (1) reduce process-derived impurities to achieve target product profile; (2) maintain process robustness to process changes; and (3) achieve reliable scalability from lab to production.…

July 30, 2014

Reducing the Host Cell DNA Quantitation Bottleneck: Approaches for Improved Sample Preparation and Throughput

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The removal of impurities arising from host cells used for the production of biopharmaceutical products is a crucial step in the purification process. Regulatory guidance for products produced in cell culture specifies that residual host cell DNA content in the final product should be as low as possible. Because of the low sample throughput typical of most quantitative DNA assays, host-cell DNA quantitation can become an analytical bottleneck during process characterization.

In this webcast, speakers will discuss a qPCR-based system for highly sensitive, accurate quantitation of residual host-cell DNA from a variety of cellular production systems, including Chinese Hamster Ovary (CHO), E. coli and Vero cells. Case studies will be presented that demonstrate DNA recovery from highly complex test sample matrices, typical of those in biopharmaceutical manufacturing environments. Options for automated sample preparation, testing results from samples typical of a monoclonal antibody purification process and results from an external validation study, executed according to ICH guidelines, will also be reviewed.

July 1, 2014

Enabling Greater Process Control and Higher Protein Titers: Advances in Downstream Single-Use Technologies

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Downstream protein purification (the stage in which a protein is isolated and purified) is one of the last steps in biotherapeutic manufacturing. Single-use technologies are an increasingly popular choice for both upstream and downstream bioprocessing because they offer significant benefits over traditional multiuse manufacturing systems. Single-use technologies also provide an array of logistical benefits, including reduced costs, minimized risk of cross-contamination, and improved operational efficiency (1). Challenges remain, however, in designing a complete, streamlined, single-use process for downstream protein purification.…

June 1, 2014

Highly Concentrated Protein Formulations: Finding Solutions for the Next Generation of Parenteral Biologics

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Therapeutic protein formulation is no easy task. Biological drugs may be destined for prefilled syringes or glass vials, or they may be made into lyophilized powders that will be reconstituted in a clinical setting. No matter what their final state will be, recombinant proteins must remain potent and efficacious during storage. In recent years, pharmaceutical companies have turned increasingly to high-concentration protein formulations. Such drug formulations can offer patients the convenience of self-injection — instead of a trip to the…

May 1, 2014

KrosFlo® Research IIi Tangential Flow Filtration System

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Spectrum Laboratories’s the KrosFlo ®Research IIi Tangential Flow Filtration System (KRIIi) is the only commercially available system with hold up volumes as low as 1 milliliter. Spectrum’s innovative, semi-automated TFF System, is ideal for small volume, R&D scale microfiltration and ultrafiltration. The KRIIi system can be used to concentrate and wash, viruses, proteins, nano-particles, and cells, at low volumes, with remarkable recovery rates. Hollow Fiber Tangential Flow Filtration is fast becoming the preferred method of large and small scale processing, due to outstanding efficiency and easy scalability compared to cassette or centrifugal devices.

April 1, 2014

TOYOPEARL GigaCap® DEAE-650M Preserving Resolution at Increased Protein loads

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TOYOPEARL GigaCap DEAE-650M is an ideal anion exchange resin for the chromatographic purification of biotherapeutic products. Since the TOYOPEARL GigaCap DEAE-650M has such a high dynamic binding capacity, the need for very large columns and massive buffer consumption is minimized, particularly for proteins expressed at higher levels due to upstream improvements.

April 1, 2014

High–Cell-Density Clarification By Single-Use Diatomaceous Earth Filtration

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Single-use concepts are widespread in all unit operations of the biopharmaceutical industry. Although single-use technology is rapidly advancing and considered to be highly advantageous in many regards (1,2,3), in some cases it cannot (yet) compete with classical manufacturing systems. Processes with a demanding character (e.g., high cell densities, high titers, high turbidities, increased particle/contaminant loads) especially can bring disposables to their limit of technical feasibility, especially in product harvesting (4,5,6). Here we focus on that step, which is defined as…

April 1, 2014

Accelerating Purification Process Development of an Early Phase MAb with High-Throughput Automation

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    Monoclonal antibodies (MAbs) are the fastest growing segment in the biopharmaceutical industry because they are potentially efficacious in the treatment of diseases such as cancer and autoimmune disorders (1,2). With steadily increasing demand for efficient and affordable therapies, speed to clinic/market is important, and biopharmaceutical companies push multiple drugs into development each year to ensure business sustainability (3,4,5,6). Downstream purification process development for therapeutic MAbs is a critical step on their path to reach clinical trials and beyond…

March 1, 2014