2021

28 Years of Experience Developing and Manufacturing Biopharmaceuticals

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Avid Bioservices, Inc. is a full-service, dedicated contract development and manufacturing organization (CDMO) focused on biopharmaceutical drug substances derived from mammalian cell culture. Avid’s services include process development and current good manufacturing practice (CGMP) clinical and commercial drug-substance manufacturing, bulk packaging, release and stability testing, and regulatory submissions support. For early stage programs, the company provides process development activities such as upstream and downstream development and optimization, pilot-scale manufacturing, analytical methods development, and testing and characterization. Avid has 28 years…

August 27, 2021

Partnering with Innovators: From Raw Materials to Commercial-Ready Processes

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Advancements in life sciences technologies and the increasing demands for improved, effective, and innovative products to prevent, treat, and in some cases, cure diseases have focused the attention of drug developers on new modalities such as mRNA-, DNA-, viral vector-, and cell-based therapies and vaccines. Novel biopharmaceutical products bring a level of complexity to developing and bringing them through design, clinical studies, and to the market. Like traditional drug products, complex therapies require robust, scalable manufacturing processes, a reliable quality-driven…

August 27, 2021

Corning X-WASH System: DMSO Reduction of Cryopreserved Human Mesenchymal Stem Cells

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Cryopreservation is a necessary part of workflows for both autologous and allogeneic therapies. The ability to cryopreserve cells for cell therapy increases the range of administration, shelf life, and time for safety testing. Cryoprotectants such as dimethyl sulphoxide (DMSO) often are added to freezing media to increase post-thaw cell survival. However, DMSO itself can be cytotoxic, so reducing its final concentration can be necessary. Below, I demonstrate how the Corning X-WASH system can reduce the amount of DMSO used in…

August 27, 2021

Financial Benefits of Off-Site Prefabricated Cleanroom Infrastructures

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Traditional cleanroom infrastructures, gypsum, or monolithic wall panels have been used in the past with varying success and benefit. One of the most often proclaimed benefits is the cost of those on-site built structures. Characteristically, the cost quoted at the beginning of a construction project seems to be attractive, but construction estimates are not better than ±50% at feasibility (preconcept) and ±25% at end of conceptual design. Given the above accuracy ranges, industry surveys establish that in most cases, the…

August 27, 2021

Accelerating the Development of Cell and Gene Therapies: From Discovery to Biomanufacture

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Oxgene, a WuXi Advanced Therapies (WuXi ATU) company, provides cell and gene therapy pioneers around the world with technologies, automation platforms, and service solutions to advance their preclinical research and accelerate their timelines to good manufacturing practice (GMP) manufacturing. WuXi ATU, a global contract testing, development, and manufacturing organization (CTDMO), offers world-class, integrated GMP manufacturing and testing platforms to reduce time to market, while maintaining high titers, high levels of quality assurance, and full regulatory compliance. Together, our complete end-to-end…

August 27, 2021

Biopharmaceutical Development and CGMP Manufacturing: Expansion of Capacities for Clinical and Commercial Supply

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Richter-Helm BioLogics is a leading and steadily growing contract manufacturer based in Germany. We comply with good manufacturing practice (GMP) and specialize in microbial biopharmaceutical products. Our work focuses on recombinant proteins, plasmid DNA, antibody fragments, and vaccines. Clients worldwide already have benefited from our commitment to GMP, flexibility, and total transparency. With a proven 30-year track record and highly skilled professionals, Richter-Helm supports you with process development, supply of products for clinical trials, commercial production, in-house quality control (QC)…

August 27, 2021

Freeze Cycle Testing of
Fluoropolymer Bottles

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Frozen storage of bulk drug substances (BDS), including bioprocess solutions, vaccines, blood components, and other delicate process fluids is common in the bioprocess industry. Vessels used to store those fluids must be capable of withstanding long-term storage in extremely cold temperatures (e.g., –85 °C or –196 °C), sometimes for very long time periods. They also must also maintain integrity after repeated thawing and subsequent refreeze. The study below was performed to characterize performance of fluoropolymer bottles with standard and two-piece…

August 27, 2021

Autologous CAR T Cell Manufacturing Using a Semiautomatic, Closed, Modular Workflow: Seamless Transition from Discovery to Clinical Manufacturing

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Chimeric antigen receptor (CAR) T cell therapies have advanced rapidly in recent years, with a number of targets in clinical research and several US Food and Drug Administration (FDA)-approved products already on the market. There has been tremendous effort to make CAR T cells more effective, safe, and persistent when treating patients. On the manufacturing side, however, errors, lot-to-lot variation, and contamination can be associated with open processes and manual handling of CAR T cells. Cell isolation, gene editing, expansion,…

August 27, 2021

Prepared for the Future?
Smart Maintenance Is Key to Industry 4.0

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With the rapid advancement of digitalization, new technologies and flexible production concepts have become essential parts of the biopharmaceutical industry, especially for implementing Industry 4.0, the Internet of things (IoT), and predictive maintenance. As an expert partner for digitalization, Zeta supports its customers with new tools for smart maintenance. Swift commissioning helps biomanufacturers complete their projects successfully. That requires trained personnel and maintenance support. Intelligent tools based on digital plant data ensure smooth operation. Smart Maintenance Navigator (SMN) technology is…

August 27, 2021

Enabling High-Performing
Perfusion Cell Culture

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At least one report estimates that by 2025, 35% of biologics will be manufactured using enhanced processes, particularly perfusion-based bioprocessing. Results of two innovations that support this need for enhanced processes are examined below. The Thermo Scientific HyPerforma DynaDrive Single-Use Bioreactor (SUB), the latest advancement in SUB technology, offers better performance than other bioreactors and scalability up to 5,000 L. Gibco High-Intensity Perfusion CHO Medium is formulated to provide exceptional performance and ease of use, with capability of sustaining >1…

August 25, 2021