August 2013

High-Performance Biopharmaceuticals Manufacturing

Identifying the most appropriate contract manufacturer that is most likely the best match for your lead pharmaceutical candidate is a true challenge. Rentschler is a biopharmaceutical manufacturer with over 35 years proven track record. Focused on mammalian cell lines, our experience covers the development, production, and aseptic filling of recombinant proteins such as cytokines, enzymes, monoclonal antibodies, and fusion proteins in compliance with international GMP standards (EMA/FDA). We don’t just claim to be reliable and experienced; our many successful projects…

More Functionality, Lower Costs, Better Usability with the Arc System

Figure 1:  Figure 1:  When planning a modern 750-L fermentation plant including a cross-flow unit, the GEA Diessel company was looking for the best available measurement technology suited for its customer requirements. Attention turned to the new intelligent Arc sensors from Hamilton. After testing the Arc system, the plant engineer and GEA’s customer were convinced of the advantages of the new technology, deciding to use the Arc system in the fermentation plant. GEA Diessel and Hamilton were able to supply…

Separation of Monoclonal IgG and Its Aggregates Using TOYOPEARL MX-Trp-650M

The importance of proper aggregate removal during polishing of a monoclonal antibody (MAb) for therapeutic use is beyond controversy. Severe anaphylactic reactions have been described in the literature for the application of aggregated proteins as a drug byproduct. Traditionally, ion-exchange chromatography (IEX) or hydrophobic-interaction chromatography (HIC) are used to purify a structurally homogeneous product. In case those platforms do not satisfy the requirements for MAb polishing, advanced chromatography resins need to be considered. For instance, mixed-mode stationary phases such as…

Biopharmaceutical Development and GMP Manufacturing

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 Development of production strains (Escherichia coli, Pichia) Establishment of MCB/WCB Development of fermentation (1 to 1,500 L) and…

Labfors 5 with LabCIP

Table 1:&#8 The need for a rapid turn-around in quantity (and the loss of technicians in many laboratories) has created a trend toward single-use vessels. Their advantages include no time lost in cleaning or sterilization (especially for bench-scale, autoclavable systems), no chance of inhibition or cross-contamination due to poor cleaning, and no need for cleaning and sterilisation facilities in a crowded laboratory. For production-scale steel bioreactors, fully automated clean-in-place (CIP) and sterilization-in-place (SIP) has been possible for decades. By contrast,…

Large-Scale Expansion of Hepatic Progenitor Cells

Cell therapy is offering a promising future in medical advances. Although multilayer trays are suitable for R&D and preclinical cell amplification, they cannot support large-scale industrial production. A successful transition from laboratory scale to an efficient and robust process based on good manufacturing practice (GMP) is key. The Integrity® Xpansion™ multiplate bioreactors have been specifically designed to enable an easy transfer from existing multiple-tray stacks processes by offering the same cell growth environment on two-dimensional (2D) hydrophylized polystyrene (PS) plates…

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

Large Scale CHO Transient Gene Expression Using Flow Electroporation

Researchers have turned to Chinese hamster ovary (CHO)–based transient gene expression (TGE) as an alternative to CHO stable cell line production for early stage antibody development. Despite advances in transfection methods and culture optimization, most CHO-based TGE systems produce antibody titers (low mg/L) that are insufficient for full use in biotherapeutic development pipelines. MaxCyte electroporation is a universal, transient transfection platform with unmatched quality, flexibility, and scalability and the capacity to transfect up to 2 × 1011 cells in under…

From Concept to Completion

Ajinomoto Althea is a contract developer and manufacturer of biopharmaceutical and injectable products, with fully integrated product development and CGMP manufacturing expertise to support client projects from preclinical development through commercial supply. Each project program at Ajinomoto Althea is tailored to the specific needs of your product, allowing you to leverage our entire integrated manufacturing approach or just the parts you need. While realizing all the tangible benefits of consolidating your development and manufacturing steps, you’ll also have the confidence…

Passion for Your Process, Product, and Patients

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) CGMP manufacturing facility meets FDA, EMA, and HPFB regulatory standards and includes flexible clinical and…