2016

High-Performance Biopharmaceutical Contract Development and Manufacturing

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Rentschler is a full-service contract development and manufacturing organization (CDMO) and one of the leaders in the industry. Focused on the development and manufacturing of biopharmaceuticals in mammalian cell culture, we support our global clients through to market approval of their products. Delivering successful projects allows us to make an essential contribution to the global availability of biopharmaceuticals. Thanks to many years of experience, the high quality of our consulting services, and our flexibility, we can react quickly and effectively…

August 10, 2016

Biopharmaceutical Development and GMP Manufacturing: Preclinical to Commercial Supply

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Richter-Helm is a Hamburg, Germany–based contract development and manufacturing company with a proven 25-year track record, specialized in products derived from bacteria and yeasts. Count on us to flexibly provide a comprehensive range of services and customized solutions. Clients worldwide already have benefited from our commitment to good manufacturing practice (GMP) and total transparency. Our work focuses on recombinant proteins, plasmid DNA, antibody fragments, and vaccines. Our seasoned, 160-strong team supports you with process development, supply of products for clinical…

August 10, 2016

Vetter: A Strategic Partner Focused on Your Success

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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. Resources for Every Stage of Growth Vetter’s full portfolio of services includes dedicated resources for both clinical development and commercial manufacturing. In addition, we provide expert packaging technologies and solutions tailored to your product’s specific market needs. Vetter Development Service Planning for Success:

August 10, 2016

The Microbial CMO: Process Development and Manufacturing of Biologics

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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 production of biologics for clinical trials and commercial supply. Founded in 1999 as a spin-off from the Hans-Knöll Institute in Jena, we are a 100% subsidiary of Wacker Chemie AG since 2005. The sites in Jena and Halle provide a complete range of services for the development…

August 10, 2016

Optimize and Monitor Product Integrity

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Development of a single drug, whether it is a new chemical entity, biotherapeutic, or cellular therapy, requires significant investment of resources. Care must be taken to choose analytical methods that are fit for the purpose of monitoring products 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. Protein Aggregation

August 10, 2016

Rapid Affinity and IgG Titer Analytics: Automating Bioanalysis with Gyrolab Nanoliter-Scale Technology

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In the development of biotherapeutics, there is a need to quantitate antibody titer and to characterize antibody affinity against the target of interest. Such analyses are often challenged by the need for sensitivity, reproducibility, and higher throughput. Gyrolab systems automate and miniaturize affinity measurements and IgG titer quantification in a single platform using only nanoliter volumes with rapid time to results. IgG Titer Immunoassays with Broader Ranges for Cell Line Development

August 10, 2016

Rapid HCP Immunoassay Kit Selection: One HCP Kit Does Not Cover All Possible HCP Mixtures

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Host cell protein (HCP) levels in biologics are on the critical path for assessing product quality, and they pose a serious risk to drug safety. The challenge is to accurately quantify a complex mixture of HCP impurities, which vary in properties and abundance depending on cell line, media, and process parameters. HCP immunoassay analysis is based on polyclonal antibodies raised against HCPs from nontransfected cell lines. How well a particular HCP assay recognizes all proteins depends on how well the…

August 10, 2016

Maximize Your Discovery and Development Productivity with Automated nanoDSF

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Assessment of thermal stability parameters of biologics is an integral part of biopharmaceutical research. The ever-growing number of biologics in development pipelines worldwide demands rapid and precise methods to quickly screen large sets of conditions in an easy and straight-forward manner. In a recent study, we compared two methods for detection of thermal unfolding transition temperatures (Tm) of a therapeutic monoclonal antibody (MAb): nanoDSF, which analyzes changes in the fluorescence emission properties of proteins, and differential scanning calorimetry (µDSC), which…

August 10, 2016

Letter to Readers

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  Thank you for taking the time to view our supplement, which has been driven by our desire to share actionable knowledge in a convenient format as well as to act as a guidepost for the evolution of continuous processing. As you read, we encourage you to ask questions, share your thoughts, or send general input/requests to our team at www.pall.com/ continuous-questions. We hope that this supplement encourages a deeper discussion about continuous bioprocessing technology and the dramatic impact it…

June 27, 2016