Industry Yearbook 2015-2016

Application of SoloVPE to UV Concentration Measurement

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. Read the full text of this application note in the…

The Effect of Rocking Rate and Angle on T-Cell Cultures Grown in Xuri™ Cell Expansion Systems

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…

The Path to Commercial Cell Therapy Manufacturing: Developing a Strategic Roadmap

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. Read the full text of this application note in the PDF (Login required).

High-Performance Biopharmaceutical Contract Development and Manufacturing

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…

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…