2008

The Genesis of New Production Tools for Biotechnology Manufacturers

The biotechnology industry has from the start been characterized by its dependence on innovation. New therapeutics, new indications, new technologies — and the continual drive toward new approaches for optimizing processes — all contribute to getting novel products to the market (and to patients) efficiently and cost-effectively. Most of the technical literature reports on development processes for the therapeutic products themselves. But one element largely ignored forms an essential foundation to the work of the biotechnology industry: How are products…

Global Vaccine Commercialization

Defining the optimal market entry strategy for a vaccine is challenging. Worldwide, vaccine markets are commoditized andvery heterogeneous. In addition, with growth and evolving technology, the business model in the vaccines sector is changing. From the traditional vaccine model, constituted mainly of pediatric vaccines used to prevent a well-known series of viral and bacterial infections in large cohorts of healthy patients, we are seeing the emergence of a more pharma-like model that has been stimulated by new technologies, innovation, and…

The Emerging Generation of Chromatography Tools for Virus Purification

Chromatography media and methods have evolved continuously since their introduction a half century ago. Traditional methods use columns packed with porous particles. They still dominate chromatography applications in the field of virus purification, but the past 20 years have witnessed the ascendance of alternative supports, namely membranes and monoliths. These newer media exploit the familiar surface chemistries — ion exchange, hydrophobic interaction, and affinity — but they use unique architectures that offer compelling performance features. The Architecture of Chromatography Media…

Managing the Analytical Life-Cycle for Biotechnology Products

The analytical program for a given biotherapeutic has a life-cycle analogous to that of a manufacturing process used to prepare material for clinical and commercial use. This two-part article discusses analytical activities associated with the progression of biotherapeutic candidates from the early stages of clinical development through their appearance as licensed drugs on the market. In Part One, we examined the stages of the analytical life-cycle. Here we conclude by going into more detail on challenges associated with method qualification,…

Implementing Single-Use Technology in Biopharmaceutical Manufacturing

In biopharmaceutical manufacturing, single-use components and systems can offer distinct advantages over reusable, cleanable systems. Deciding whether to move to a single-use approach, however, depends on many factors. In a recent review of biomanufacturers and CMOs, the risk of leachable materials entering drug products was highest on a list of end-user concerns, as shown in Figure 1 (1). That’s not surprising in view of the high organic polymer content of disposable components, a general inexperience with such polymeric materials in…

BMD Summit

Implement Disposables and Operational Excellence Strategies to Optimize Facility Use and Achieve Cost and Waste Reduction Cost pressures on the biopharmaceutical industry are mounting from domestic consumer demand, the growth of biosimilars, and emerging manufacturers around the globe. For organizations to remain competitive and gain sustainable cost reductions, they must drive innovation and accelerate their rate of implementation of novel technologies. IBC’s fourth international BMD Summit once again provides the latest case studies, regulatory updates, and new strategies for incorporating…

Modeling Flow Distribution in Large-Scale Chromatographic Columns with Computational Fluid Dynamics

Column chromatography remains a key unit operation in downstream processing of biopharmaceuticals. For most commercial processes, two to three chromatography steps are used to remove process-and product-related proteins, DNA and adventitious agents. As the biopharmaceutical industry has increased its product offerings and related demands, downstream processes have fast become a bottleneck (1, 2). Many commercial and clinical processes include a number of cycles on one or more chromatography steps to process the harvest from a single production batch. PRODUCT FOCUS:…

Products, Services, and Literature

Mixing Options Product: PSU-20 microcompressor Application: Biotechnology/biopharmaceutical development and academic research Features: A new bench-top heavy-duty platform shaker provides three mixing functions (orbital motion, reciprocation, and vibration) and the flexibility of a range of interchangeable platforms. It includes a high-capacity, four-level “hotel” format platform to minimize its footprint. The mixing functions are fully programmable and can be set for continuous or timed operation from one minute to 96 hours to achieve optimum mixing in a single mode or in different…

“Combine All Files” Maps

Many proteins are regulated by posttranslational modifications (PTMs) such as deamidation, phosphorylation, and glycosylation. Documented effects of PTMs include changes in enzymatic activity, interactions with other proteins, subcellular localization, and targeted degradation (1, 2). Also these physicochemical modifications may also affect receptor binding (3) or higher order structure (4) and result in clinical effects such as changes to bioactivity, immunogenicity, and bioavailability (5). The development of analytical technologies to rapidly interrogate protein structure also has direct relevance to the biopharmaceutical…