Challenging conventional process technologies with innovation and forward-looking solutions lead to the next generation of manufacturing processes. With its biotechnology, chemistry, and fine chemistry capability, DSM has an extensive toolbox for developing the most economic and sustainable solutions for customers. DSM’s biotechnology uses microorganisms, enzymes, and mammalian cells to produce novel ingredients and improve existing food ingredients, (bio)pharmaceuticals, plastics, and chemicals. Mammalian Cell Culture–Based Manufacturing A state-of-the-art facility, located in Groningen, The Netherlands, is dedicated to the development, scale-up, and…

      Established at the forefront of current good manufacturing practice (cGMP) cell-based potency assay contract testing, Eurofins Lancaster Laboratories, Inc. provides assistance in all aspects of bioassay development, validation, method transfer, and long-term assay maintenance. Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity, and impurities — is necessary to establish the safety and efficacy profile of a given product (as per ICH Q6B guidelines). Cell culture–based potency assays…

Rentschler Biotechnologie GmbH is a global, full-service contract manufacturer with over 35 years of experience in the development, production, and approval of biopharmaceuticals in compliance with international GMP standards (EMA/FDA). 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 30 L, 250 L, 500 L, 1,000 L, and 2,500…

      Richter-Helm has more than 25 years of experience in the development and good manufacturing practice (GMP)–compliant production of a wide range of biopharmaceuticals, including recombinant proteins (e.g., cytokines, growth factors, antibody fragments, surface antigens) plasmid DNA microbial vaccines (e.g., attenuated whole cell vaccines).   Customized Solutions   Richter-Helm offers customized solutions for all steps in biopharmaceutical projects through contract development and manufacturing services featuring GMP state-of-the-art facilities for microbial production fermentor scale up to 1,500 L strong…

      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. Our expertise is based on numerous projects successfully performed in collaboration with our customers.…

      Recent advances in the research of therapeutic biologics have resulted in increased market demand for novel manufacturing systems to help meet the growing production need. Recent data resulting from increased research into the human immune system has resulted in the development of innovative treatments for a number of diseases with large unmet need both as vaccination and therapy. To compliment this growth, new approaches in pharmaceutical manufacturing help to fill complex biological products, not only to secure…

      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. A second…

Small-pore, virus-retentive nanofilters are designed to remove even tiny viruses from a biological product intermediate as it flows through the filter membrane. During process development, manufacturers carefully optimize filtration conditions to maximize product throughput so that at manufacturing scale, the number and size of these expensive virus filters can be minimized. During the viral clearance study, an attempt is made to filter a targeted volume based on preceding process development studies. If the filter’s pores become plugged with impurities from…

Clarifying cell culture broth is the first downstream unit operation in an elaborate sequence of steps required to purify a biological therapeutic. The availability of large-scale, single-use depth filtration technology in recent years has given process developers the capability to improve and simplify downstream processes. The Zeta Plus™ Encapsulated System is a single-use depth filtration system designed for the bioprocessing industry where upstream cell culture clarification or downstream impurity removal is required. The Zeta Plus Encapsulated System consists of a…

  Background     Tryptic soy broth (TSB) is a general-purpose medium used for cultivating numerous microorganisms including Serratia marcescens, a Gram-negative rod commonly found in water and involved in pharmaceutical contaminations (1, 2). This study examines the growth characteristics and bacterial retention of S. marcescens (ATCC #14756) in five types of TSB: EMD TSB (type 1), EMD Irradiated TSB (type 2), EMD Non-Animal Origin TSB (type 3), EMD Non-Animal Origin Irradiated TSB (type 4), and Competitor ATSB (type 5).…