Improving efficiency in buffer delivery is an important part of meeting the goals of Biophorum’s road map for the future, which could be a critical strategy in increasing productivity and decreasing costs.
Working within a critical environment such as a clean room necessitates high-quality materials and equipment. To provide products that meet the needs of the applications, materials and consumables must conform to a variety of specified standards. This white paper explains how clean parameters are defined and validated.
Our collective responsibility as participants in the gene therapy industry is to discover, develop and bring these innovative therapeutics to patients in need with a sense of urgency, effectively balanced, of course, with quality and safety. Success in the evolving and highly competitive gene therapy space, however, requires navigating many uncertainties related to process development and manufacturing of adeno-associated virus (AAV) and lentivirus vectors, especially when development and manufacturing teams are operating with compressed timelines.
The path from DNA to clinic to drug-in-vial is long and complex. Upstream development is rich with opportunities to guide a promising molecule toward success. The choices made during upstream development can strongly influence the success of a biologic candidate. Following are some considerations that can simplify the process, improve process economics and minimize risk and uncertainty while helping customers deliver their molecules to market as quickly as possible.
As gene transfer vehicles, lentiviruses exhibit many desirable properties, such as high transduction efficiencies, ability to infect both dividing and nondividing cells, and stable integration into the host cell genome. These properties make them well-suited for in vivo and ex vivo gene and cell therapies. However, cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.
Working in close partnership, Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine, and MilliporeSigma, the life science business of Merck KGaA, Darmstadt, Germany, are combining their bioprocess and engineering expertise to advance and optimize the manufacturing process for a promising new preventive recombinant proteinbased vaccine, to end the scourge of Schistosomiasis, one of the world’s most devastating and pervasive parasitic infections and neglected tropical diseases.
The decision whether or not to outsource buffer preparation is not clear-cut, but provides an opportunity to balance risk with reward.
Analyses of the biopharmaceutical industry predict that the market for vaccines could grow at a compound annual growth rate of as much as 10.3% between 2013 and 2024. The vaccine industry requires new tools to help bring its pipeline of new products to the market quickly, safely, and economically. Read how Sartorius Stedim Biotech (SSB) is exploring the best ways of implementing single-use platforms for next-generation vaccines that avoid reinventing the wheel for each candidate, thereby reducing time to market, lowering production costs, lowering risks, and increasing flexibility.
Chemical development is a time-consuming, expensive, and labor-intensive process. Traditionally, new chemicals are developed using batch processing, which fully relies on versatile and qualified equipment to perform different unit operations. To address these above challenges, continuous flow chemistry technology is currently emerging as an effective tool to conduct chemical synthesis, both at the micro and mesoscale, providing an improved product quality with safe and environmentally conducive process in comparison to traditional batch synthesis.
To meet global demand, it is predicted that next generation vaccines will be based on recombinant approaches and be produced in intensified single-use systems (SUS) to increase capacity at reduced costs. However, despite their benefits, SUS for vaccine manufacturing face a number of key regulatory challenges, which require greater reliance by the biopharmaceutical industry on SUS suppliers. This article details how Sartorius Stedim Biotech (SSB) is leveraging its quality strategy to address these issues by partnering with polymer and film suppliers to combine material science, film extrusion and bag making expertise, allowing in-depth characterization and process control of extractables/leachables substances and particles profiles of its SUS.
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