Over the past decade, the cell therapy field has matured into the next generation of medical technology. In both the United States and the European Union, physicians now have an option to write prescriptions for manufactured engineered cell therapeutics, as they routinely do for prescription medications. And the number of available commercial cell therapies is expected to grow. However, unlike traditional pharmaceuticals, engineered cell therapeutics require geographically dispersed networks of cell collection, engineering, manufacture, distribution logistics, and treatment facilities, thus…

          Rentschler Biotechnologie GmbH is a full-service contract manufacturer with over 35 years of experience in the development, production, and approval of biopharmaceuticals in compliance with international GMP standards with a highly skilled staff of 650. As part of the Rentschler Group and headquartered in Laupheim, Germany, Rentschler is one of three leading European CMOs operating globally. Dedicated to delivering high-quality biopharmaceuticals produced in mammalian cell culture, Rentschler has nine stand-alone GMP suites with volumes of…

Repligen™ OPUS (open Platform User Specified) prepacked columns packed with CaptivA™ PriMab™ Protein A resin offer high performance and all the advantages of single-use technology (reduced validation effort, reduced risk, faster time-to market). What makes this solution truly unique, however, is that oPUS prepacked columns provide lower total cost of ownership in many applications compared with conventional stainless steel or glass columns. Single-Use Chromatography Study BioPharm Services ltd (Chesham, UK) conducted a study to assess the impact on total cost…

Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than wo decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offer 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. Our expertise is based on numerous projects successfully erformed in collaboration with our customers. Currently, Sandoz is…

Filters rated at 0.1 µm have been increasingly used for cell culture media filtration due to concerns about mycoplasma contamination of cell cultures. Sartorius Stedim Biotech has recently launched a new 0.1-µm, mycoplasma-retentive, sterilizing grade filter: Sartopore® 2 XLM. it is a heterogeneous, double-layer PES membrane filter with a highly asymmetric 0.2-µm prefilter layer in-built with the same 0.1 µm mycoplasma-retentive final membrane as its predecessor, Sartopore® 2 0.2/0.1. Sartopore® 2 0.1-µm. 10″ cartridges have been validated as mycoplasma-retentive by…

The development of insect cell culture production systems has produced opportunities for the expression of recombinant proteins for research and therapeutic applications in a non–mammalian cell culture environment. Various insect cell lines have been developed for the baculovirus expression vector system (BEVS). Development of stable transfected Drosophila and lepidopteran cell lines has offered a nonlytic culture for the production of recombinant proteins from insect cells. Spodoptera frugiperda Sf9 cells have been successfully adapted to suspension culture and have become an…

          Vetter, a leading provider of aseptically prefilled drug-delivery systems, launched a new state-of-the-art facility at the Illinois Science + Technology Park in suburban Chicago. The site offers a central US location with a domestic and international airline hub. Moreover, it is uniquely situated in a thriving biopharmaceutical region that offers an established infrastructure, prominent research institutions, and a talent pool of 70,000–80,000 professionals. An expansion of Vetter Development Service, the Chicago site supports preclinical through…

Since 2006, Vivalis has operated and maintained a GMP manufacturing facility for the production of monoclonal antibodies, recombinant proteins, and viral-based products. Founded in 1999, Vivalis has developed a series of innovative technologies to address the needs of biopharmaceutical development. These include novel cell substrates, such as our avian EB66® cell line, which has seen wide application in areas from vaccine manufacturing to monoclonal antibody development. Our CMO services not only include those for clients using the EB66® cell line,…

Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with more than 20 years of experience in microbial systems. We offer proprietary technologies (ESETEC®, DENSETEC®) that significantly lower the cost of goods. Our customers benefit from a comprehensive service for the development of robust and highly efficient processes and GMP-compliant manufacturing for clinical trials and commercial supply. We opened recently a new process-development unit to optimize the entire process-development chain, from gene to purified protein. Asecond extension at the Jena…

          For many developers of new biologics, outsourcing clinical or commercial manufacturing with a contract manufacturing organization (CMO) makes good sense. Dozens of capable CMOs offer ready capacity to companies who can’t afford the time, capital or risk involved in building their own biomanufacturing capacity. Of course, the convenience of instant access to a CMO’s infrastructure comes at a steep price: Many CMOs use proprietary cell lines, media, and other technology that will limit a drug…