biopharma

Bispecific antibodies pose unique challenges in downstream processing. See how impurities were efficiently removed by mixed-mode chromatography in this webinar.

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In recent years, biologics — drugs derived from living culture systems — have become increasingly significant in the fight against a plethora of conditions. Unfortunately, the efficiency of these drugs comes at a cost. A daily dose of a biologic drug costs, on average, 22 times more than conventional small-molecule drugs. Therefore, biosimilars are developed to make them more accessible. Lung cancer is an example where the development of biosimilars could increase treatment options available for patients.

Biotherapeutic antibody discovery is inherently challenging. Amongst the clinically proven technologies for antibody discovery is phage display — a technique utilized by one of the most recent and innovative solutions on the market: the Pioneer Antibody Discovery Platform.

The therapeutic potential of messenger RNA (mRNA) therapeutics has an unprecedented ability to target previously undruggable diseases. The poly(A) tail drives the therapeutic efficacy of the mRNA molecule. Using Droplet Digital PCR (ddPCR) technology to analyze poly(A) tail length and integrity yields unrivaled sensitivity, enabling developers to ensure high poly(A) tail integrity and, ultimately, functional therapeutic mRNAs.

Lentiviral vectors (LVVs) have become the primary method of gene delivery for cells ex vivo in both academic and clinical applications. Currently, qPCR is the gold standard for functional titering of LVVs, but Droplet Digital PCR (ddPCR) offers an attractive alternative due to its inherent benefits, such as absolute quantification without the use of a standard curve and enhanced resistance to PCR inhibitors.

The realm of druggable targets has expanded significantly with the advent of mRNA therapeutics. Scientists require exceptional accuracy and confidence to adequately characterize these therapeutics and their anticipated effects. To this end, Droplet Digital PCR (ddPCR) technology has proven invaluable. With unparalleled precision and absolute quantification, Droplet Digital PCR is revolutionizing the field of mRNA therapeutic development and manufacturing.

Viral clearance studies are part of a multifaceted approach to ensure biopharmaceutical product safety. To prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency early on during downstream process development. See how a design of experiments (DOE) approach was utilized in this case study to investigate the effect of buffer pH and conductivity on the removal of impurities by an anion exchange (AEX) mixed-mode chromatography resin.

Large-scale downstream processing of viruses can face a range of obstacles different from those of many biotherapeutics. These challenges mostly arise from the size and complexity of the virus, which can affect product purity and recovery. Improvements of purification tools are necessary to overcome these challenges and must be engineered for easy scalability to meet manufacturing demands. In this video, Dr. Mark Snyder discusses common difficulties when developing purification strategies for vaccine production and gene therapy.

This webinar presents a downstream processing workflow for recombinant human insulin production from E. coli. Learn how proinsulin and insulin can be purified.