July 2008

Single-Use Technology for Aseptic Filling

Photo 1. Biopharmaceutical processing has been greatly improved over the past 10 years with the introduction of single-use/disposable technology. There has been a landslide of disposable products introduced in the areas of filtration, mixing, sampling, and transferring solutions aseptically. It is common to find papers and studies that detail the efficiencies that disposables offer to the biopharmaceutical market. What about aseptic filling? More importantly, what about the cost of aseptic filling? PDC aseptic Filling Systems offers an answer. The biopharmaceutical…

PACE™ Cell Technology

Figure 1. The costs of producing monoclonal antibodies (MAbs) from mammalian cells are extremely high. Producing 500 kg/year of a MAb can run $200,000,000/year or more. Great effort has been made by the biopharmaceutical industry to reduce these costs. Companies have improved or expanded their existing infrastructures for MAb manufacturing, optimized media formulations and feeds, and/or genetically engineered production cell lines, with the current industry goal of 10 g/L titers and productivities of 100 picograms/cell/day. A twofold increase in volumetric…

CellPrime™ Recombinant Human Transferrin As an Animal-Free Alternative to Animal-Derived Transferrin or Iron Supplementation in Cell Culture Applications

Figure 1. CellPrime rTransferrin recombinant human transferrin provides an animal-free alternative to iron salts for industrial cell culture. It is a recombinant analogue of human transferrin expressed in Saccharomyces cerevisiae. Supplied as a human holo-transferrin analogue, CellPrime rTransferrin binds specifically to the transferrin receptor, thereby facilitating iron uptake into cells for optimal cell culture performance. Here we describe cell culture data demonstrating that CellPrime rTransferrin shows equivalence to human transferrin (hTf) and superiority to bovine transferrin (bTf) in stimulating cell…

Outsourcing Clinical Manufacture

The biopharmaceutical industry is a predominantly research-based industry that is rapidly maturing toward commercialization. As it does so, biopharma executives have to grapple with complex issues concerning process development, scale-up, and preclinical manufacture of material for toxicology studies, clinical studies, and eventually commercial sale. Selecting a suitable CMO, negotiating a robust contract, and managing on-going relations are of utmost importance to successfully securing a timely, quality supply of product. There are very different types of CMO. Some CMOs are biopharma…

Who We Are

For more than 25 years, Invetech has been at the forefront of breakthrough product development and automation. Today we are as recognized for our unique approach as for the resulting commercial successes. Working with ambitious start-ups through to successful global businesses, our specialist expertise in design, engineering, and manufacturing enables us to deliver solutions that are as practical as they are marketable. Our award-winning portfolio has led advances across medical, industrial, and consumer markets, enabling clients to forge new ground…

MAbs and Biotherapeutics Direct from the Bioreactor

Upfront Chromatography A/S is a Danish company with significant expertise in the development of customized industrial processes. Successful operation of industrial separations provides proven scalability for biopharmaceutical manufacturers. Upfront Chromatography’s Rhobust™ technology has been developed to maximize the effectiveness of capture adsorption steps, using second-generation expanded-bed technology. Rhobust™ consists of Mixed-mode ligand chemistry (robust adsorbents with added selectivity) Tungsten carbide densified agarose that enables robust operation of expanded bed Dedicated hardware designs (robust fluid distribution systems without meshes, frits, or…

The Next Step in Implementing Disposables

Biopharmaceutical manufacturers face increased pressure to commercialize new drugs faster and at a lower cost. As a result, production demand is outpacing available manufacturing capacity. To meet existing and future demand and maintain a competitive advantage, many manufacturers are striving to develop increased efficiencies within their manufacturing processes. This is where single-use systems — particularly single-use transfer lines — can deliver significant value, including added flexibility, improved production yields, and increased cost savings. The trend today is toward transfer lines…

Batch and Fed-Batch Cell Culture

Figure 1. How well does absorbance correlate with cell density and viability measurements in batch and fed-batch cell culture? As expected in science and nature, the answer depends on a set of factors. Many people working with batch or fed-batch cell culture will reference discrete offline measures of cell activity. Total cell density (TCD), viable cell density (VCD), and percent viability can be evaluated offline using a hemocytometer and accepted trypan blue exclusion method. Cedex® and Vi-CELL™ are two examples…

Unique Competence in Biopharmaceuticals

Rentschler Biotechnologie GmbH is a full-service contract manufacturer with over 30 years of experience in the development, production, and approval of biopharmaceuticals in compliance with international GMP standards with a highly skilled staff of 350. 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…

About i3

i3 is a global business providing integrated scientific strategies and solutions throughout the biopharmaceutical product lifecycle. Its combination of products, services, and knowledge helps companies gain sharper insights that lead to better patient care. i3 Research i3 Research is a full-service clinical research organization (CRO) focused in cardiology, central nervous system, endocrinology and metabolic disease, oncology, and respiratory and infectious disease. Therapeutic specialization drives all aspects of this group’s business — from project staffing and talent management to quality initiatives,…