July 2009

Althea Technologies, Inc.

While CMOs have traditionally been used to play a critical role in the manufacture of drug product, Althea has evolved beyond being a role player to a strategic development and manufacturing partner that can drive value to a client’s product or product candidate. As drug development costs are always increasing, a properly integrated development and manufacturing scheme can significantly decrease development time and expense, while increasing the probability of clinical success and product differentiation. To allow clients to leverage such…

Getting to Clinical Trials Faster with a Better Formulation: Symyx CDMO

      Symyx CDMO (contract development and manufacturing organization) provides a faster, more reliable route to clinical trials by delivering drug product manufactured with a highly optimized and robust formulation. We have over a decade of experience working with the smallest biotechnology start-ups and the largest pharmaceutical companies. Symyx combines formulation expertise, high-productivity research technology, and CGMP manufacturing capability in a single facility.   Biopharmaceutical Development and CGMP Manufacturing   Symyx has the subject-matter expertise and technologies to integrate…

High-Performance Sterile Filtration

Figure 1: Dead-end filters using microporous membranes of synthetic polymers such as PES, polyamide, cellulose acetate, and PVDF are extensively used for microbial control in a wide range of biopharmaceutical liquid filtration applications. Typical applications include sterile media addition into bioreactors, cell harvest clarification, chromatography column protection, and final sterile filtration of purified bulk drug substances. Downstream processing in the biopharmaceutical industry requires multiple bioburden reduction steps that commonly use 0.2-µm sterilizing grade filters. There are innovative application-specific approaches in…

Expression of a Human–Derived Growth Factor Containing Multiple Disulfide Bonds in —Based ēnex Expression Technology™

Figure 1: This protein proved to be “difficult to express” in both mammalian (CHO) and yeast (Pichia pastoris) expression platforms. In CHO cells, expression levels were very low, 1 g/L at the 96-well scale, had deletions of two proteases that when singly deleted showed marginal expression of the growth factor. When those cells are grown in a fermentor, we anticipate a further three- to five-fold increase in titer. These results powerfully demonstrate the utility of the Pfēnex Expression Technology™ toolbox…

A Dedicated Contract Development and Manufacturing Organization Focusing on the Delivery of Advanced Biologics for Customers Worldwide

Angel has provided contract development and GMP manufacturing services for recombinant proteins, antibodies, and vaccines since 2001. Responding to market demand, Angel has also built an impressive track record delivering advanced (live) biologics comprising cell therapies including stem cells, cellular vaccines, and bacteriophages. Angel is one of very few European companies providing specialist GMP manufacturing support of these products for international clients. Comprehensive Solutions Angel offers vertically integrated manufacturing solutions reducing risk, cost, and timelines for clients. We believe that…

Process Development: One Size Does Not Fit All

      SynCo Bio Partners believe that contract manufacturing should not be “one size fits all” and that the biopharmaceutical contract manufacturing industry needs to explore different collaborative business models in the development of production processes with prospective clients. Most CMOs, including SynCo, offer complete, full process, and analytical method development from the upstream fermentation/cell culture stages to the final purification steps. For small virtual companies to larger organizations with limited available internal resources this can be a good…

Single-Use Sensing Solutions

Figure 1: Single-use purification processes typically use peristaltic pumps to provide single-use fluid pathways. However, peristaltic pumps are known for generating severe pressure oscillations. These oscillations have an effect on the accurate measurement of the process, thus limiting the effective monitoring and controlling of system pressure. SciLog is pleased to announce a significant performance breakthrough in pressure monitoring: achievement of a 98% reduction in signal noise level associated with peristaltic pump pulsation. In this solution, a significant increase in the…

Ready-to-Use Devices for Optimizing Bioprocesses with Integrated Sensors

Figure 1: Bioprocess fermentors are typically equipped with real-time monitoring devices such as temperature, pH, oxygen, or even viable cell density. The advantages of on-line over off-line measurements are easiness of use, timely results, and the possibility of immediate responses to the measured value. By contrast with the well-equipped fermentors used for production, the disposables used in bioprocess development have lacked such on-line measurement devices so far. Cultivation conditions could be monitored only by means of off-line sampling, typically performed…

Avecia Biologics: Development Expertise. Manufacturing Excellence

    Adedicated contract manufacturing organization supporting the biotechnology and pharmaceutical industries from preclinical process invention to postlaunch, commercial scale manufacture. Avecia’s industry-leading expertise enables customers to improve the cost-effectiveness and profitability of new therapies, while maintaining fast-track progress into, and through, its clinical development program.   Process Development and Scale Up   Avecia’s experience ensures process development is applied appropriately dependent upon the development needs of customer products at different clinical stages. Expression in E. coli and yeast, including…

Taking the Next Step with Contract Manufacturers

Pressure is bearing down on all sides. Pharmaceutical and biotechnology companies face stress from increasing costs, intensifying global competition, growing regulatory stringency, and more. For years, they have relieved a little of this pressure by outsourcing functions to a limited extent, such as packaging or distribution. Allowing a contract manufacturer to perform some operations frees up companies to focus on their core competencies. Today, however, some of the industry’s most eye-opening success stories are the result of even more extensive…