FUJIFILM Diosynth Biotechnologies is implementing the newest evolution of UV-vis spectroscopy. The simple- to-use SoloVPE system provides accurate concentration measurements in under a minute, whereas comparable UV methods may take over an hour. This difference translates into less time spent on cumbersome in-process testing and more time spent confidently making product. It can measure concentration without the need for dilution, which eliminates pipetting and mixing errors associated with sample preparation.
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Ensuring optimal and maximal T-cell production is critical for adoptive immunotherapy and its continued success. The Xuri Cell Expansion System is an important component of the clinical manufacturing process. So we sought to investigate the effect of rocking rate and angle on the expansion of T cells. We used a combination of experimental data and predictive modeling and found that the rocking rate significantly influences the expansion potential of T cells with minimal contribution from the rocking angle. The results indicate that a rocking rate of 15 rocks per minute (rpm) and an angle of 6° are optimal for a 1-L bioreactor to maximize cell growth using a Xuri Cell Expansion System.
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The road from conception to commercialization of a cell therapy is long, complex, and resource-intensive. To be successful, a cell therapy product must be manufactured to high quality standards using a robust, cost-effective process in a manner that will scale to meet demands and be sustainable over the commercial life of the product.
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With over 40 years’ experience, Rentschler is one of the industry leaders for contract development and manufacturing (CDMO) of biopharmaceuticals based on mammalian cell culture. Delivering successful projects allows us to make an essential contribution to the global availability of biopharmaceuticals. Rentschler is an owner-managed company headquartered in Germany and acts independently on a long-term basis. Performing at the highest standard, we lead our clients’ projects to success according to their needs and timelines, which helps enhance their competitiveness in the markets.
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Richter-Helm is a dynamic and expanding German biotech company specialized in the development and manufacturing of products derived from microbial expression systems (bacteria and yeasts). Richter-Helm has more than 25 years of experience in process development and GMP-compliant manufacturing of recombinant proteins (e.g., cytokines, antibody fragments), plasmid DNA, and vaccines. With an experienced team of more than 150 employees, Richter-Helm offers tailored solutions to its customers with highest pharmaceutical quality standards confirmed by leading regulatory authorities (the European Medicines Agency (EMA), US Food and Drug Administration, (FDA), Agência Nacional de Vigilância Sanitária (ANVISA), and Ministry of Food and Drug Safety (MFDS)). In addition, Richter-Helm is the platform of its mother companies, Gedeon Richter and Helm AG, for worldwide licensing options and partnerships for codevelopment and marketing of microbial-derived biopharmaceutical projects.
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Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than two decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offers a broad variety of integrated services, including innovative expression systems, process development, scale-up, and production of recombinant products derived from microbial systems and mammalian cell culture in state-of-the-art facilities.
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Contract manufacturing of biologics is more than having superior technology — it’s having experienced people who are passionate, responsive, and committed to developing and manufacturing your biotherapeutics to improve patient care. As a fully integrated contract development and manufacturing organization (CDMO), Therapure Biomanufacturing has the scientific and technical expertise to successfully deliver at every stage of product development (preclinical, clinical, and commercial). Our 130,000-ft
2
(12,000-m
2
) current good manufacturing practice (cGMP) manufacturing facility meets FDA, EMA, and HPFB regulatory standards and includes flexible clinical and commercial production suites.
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Vetter is an international specialist in the production of aseptically prefilled syringe systems, cartridges, and vials. We are a family-owned, independent company and do not manufacture our own drugs.
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Wacker Biotech is “The Microbial CMO” — the partner of choice for contract manufacturing of therapeutic proteins using microbial hosts. Our service portfolio covers molecular biology, process and analytical development, and the GMP manufacturing of biologics for clinical trials and commercial supply. Founded in 1999 as a spin‑off from the Hans‑Knöll Institute in Jena, Germany, we are a 100% subsidiary of Wacker Chemie AG since 2005.
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Fast, accurate determination of vaccine titer during influenza vaccine manufacture (Figure 1) is important in understanding process performance and correctly scaling each process step. Traditionally, single radial immunodiffusion (SRID) assays have been used as the gold standard, but they require very skilled operators to obtain reproducible results and is relatively low throughput. ELISAs have also been used to determine titer, but they have lower precision and dynamic range. Bio-Layer Interferometry (BLI) combines the high-throughput characteristics of a 96-well- plate–based ELISA assay in conjunction with higher accuracy and reproducibility derived from a simpler direct measurement of vaccine/analyte binding.
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With the E.coli|360-HCP assay, a second host-cell protein (HCP) assay based on the novel 360-HCP ELISA concept enters the market. 360-HCP ELISA integrates four different assay types. So a scientist can evaluate in no time which kit type performs best for a specific process.
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Development of a single drug, whether it is a new chemical entity, biotherapeutic, or genetic/cellular therapy, requires significant investment of resources. Care must be taken to choose analytical methods that are fit for the purpose of monitoring product and contaminants in the process. With expertise in labeling and detection, Enzo offers solutions to help rapidly analyze protein stability and integrity for all your bioprocessing needs.
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High productivity in bioprocess development demands efficient bioanalytical procedures to measure clone expression, product titer, and process impurities. Commonly used methods such as enzyme-linked immunosorbent assay (ELISA) or high-performance liquid chromatography (HPLC) can create bottlenecks in critical workflows due to limitations in throughput, performance, and time to results.
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Since the approval of tPA derived from Chinese hamster ovary (CHO) cells in 1986, stable expression of recombinant proteins has become a very important system for the manufacture of therapeutic proteins. With an increasing number of therapeutic proteins in development, the demand for fast and robust development of manufacturing cell lines is still increasing. During the past 30 years, the productivity of stable recombinant cell lines could be increased from <100 mg/L to several g/L. The huge increase in productivity has been achieved by
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Nova Biomedical is a technology company based in Waltham, MA, that provides state-of-the-art, automated cell-culture analyzers for the biopharmaceutical market. In 1998, Nova introduced the first line of chemistry analyzers for the biotechnology industry: the BioProfile® series. Nearly a decade later, Nova added the BioProfile Flex series featuring an expanded menu and real-time analysis of key metabolites, nutrients, and gases in cell culture media. In 2011, we announced the BioProfile CDV automated cell density/viability analyzer, which measures up to 80 million cells/mL and provides results in less than three minutes.
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Microbial quality control (QC) testing is a critical aspect of pharmaceutical, medical device, and personal‑care products manufacturing. Such tests typically include the following:
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