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…
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Biopharmaceutical Development and GMP Manufacturing: Preclinical to Commercial Supply
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…
Sandoz: Provider of Customized Solutions in Biotech Manufacturing
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. Read the full text of this application note in the PDF (Login required).
Client Experience Matters!
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-ft2 (12,000-m2) current good manufacturing practice (cGMP) manufacturing facility meets FDA, EMA, and HPFB regulatory standards and…
Vetter: A Strategic Partner Focused on Your Success
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. Read the full text of this application note in the PDF (Login required).
The Microbial CMO: Process Development and Manufacturing of Biologics
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. Read the full text of this application note in the PDF (Login required).
Influenza Vaccine Titer Determination Using Bio-Layer Interferometry: An Alternative Technique for More Rapid and Accurate Influenza Vaccine Analysis
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…
Optimize and Monitor Product Integrity
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. Read the full text of this application note in the PDF (Login required).
Data-Driven Decisions to Maximize Productivity Using Automated Immunoassays in Clone and Bioprocess Development
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. Read the full text of this application note in the PDF (Login required).
Generation of High-Performing CHO Cell Lines for GMP Biomanufacturing
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…