2011

Single-Use Systems from Start to Finish

          Single-use systems have become all the rage in the biotechnology industry, driven largely by the need to reduce cleaning requirements and associated time, validation, and cost factors with stainless vessels. A well-developed single-use system will ensure lower risk of contamination in manufacturing while eliminating the cleaning process and cleaning validation.   Providing Solutions   Advanced Scientifics provides specific solutions to process needs in fluid transfer and handling, offering flexibility in the design and componentry of…

Comprehensive Global Capabilities and Extensive Scientific Expertise

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its comprehensive portfolio of services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. Working with clients of all sizes, Covance recognizes that your development program is as unique as the product you bring to our facilities. With >250 different biomolecules successfully supported annually, Covance Biotechnology Services provide you…

Chromatographic Purification in Downstream Processing

          In many biopharmaceutical companies, chromatographic purification in downstream processing is a key focus for optimization studies. The objective is to streamline the process, which may be achieved by the elimination of intermediate unit operations. The main question, therefore, is how to optimize the adjustment of individual chromatographic process steps. Currently there is a broad range of next-generation sorbents and membranes available for process chromatography. These new chromatography media are characterized by significantly improved performance compared…

CMO Selection Criteria

Selecting a CMOis critical to biotech biologic drug development. A key factor for selecting a CMOis experience. How do you measure experience? It can be measured in many ways, metrics include Number of GMP processes developed by the CMO Number of projects involving your strain Number of projects involving your product type GMP production success rate Number of GMP lots produced. Eurogentec’s Biologics Division is specialized in the manufacturing of biopharmaceuticals from microbial sources such as bacteria, yeast, and biosafety…

Automated Aseptic QC Sampling

Biopharmaceutical companies are increasingly interested in single-use innovations to improve performance and alleviate up- and downstream bottleneck constrictions. High-priority considerations for improvement include decreasing the number of process steps, reducing the risk of cross-contamination, and achieving a higher sterility assurance level. One bottleneck today is a need to collect QC samples at various steps during biopharmaceutical commercial-scale cGMP manufacturing, which typically is a labour-intensive manual activity that holds a potential risk of contaminating product or personnel. Alfa Wassermann Separation Technologies…

Rhobust® Technology

Product recovery is a lengthy and costly procedure consisting of centrifugation and depth filtration steps to remove the cells (clarification), followed by multiple cycles of packed-bed chromatography that bind and separate the target molecule from cell culture medium components (capture). The Rhobust® Technology is a second generation expanded-bed adsorption (EBA) technology that provides an elegant solution to using multiple process steps by combining clarification and product capture into one single step in the first downstream process unit operation. The Rhobust®…

Increased Load of DNA-Based Oligonucleotide on TSKgel SuperQ-5PW (20) Resin

Oligonucleotides are entering clinical trials in increasing numbers. In many ways, their entry into the clinic mirrors the development of protein therapeutics in the late 1980s and early 1990s. On the other hand, the purification process for an oligonucleotide therapeutic is very different from that for a protein. Typically one high-resolution, high-load step is used rather than a train of capture, intermediate purification, and polishing columns. TSKgel SuperQ-5PW (20) resin — a 20-µm particle size anion-exchange medium — is becoming…

Seal Intrusion — A Hidden Cost

The following is an extract from a paper presented at the Orlando ISPE Annual Meeting on November 2010 by Dr. John Toynbee. Seal or gasket material protruding into the process flow within pipework carries a number of production issues, many of which have serious cost implications. Areas of seal intrusion or recess are caused by oversized or undertightened gaskets that create a trap at the clamp union. This creates a number of production problems: System drainage and cleaning are compromised…

ALLpaQ®: A Pragmatic Approach to a Sustainable Future

Following a strong showing at this springs interphex in New York there is little wonder why ALLpaQ® has become established as an industry leader when it comes to the containment and handling of Biopharmaceutical fluids. The ALLpaQ® Cleanroom range of biotech containers was launched at interphex New York 2011. As predicted, it has since created a strong demand in Europe and is now available in the United States. Rationale Realizing that a significant proportion of the landed cost of products…

XD® Technology

DSM Biologics has developed a highly intensified cell culture process termed XD®, which provides cells with a constant environment for optimal cell growth (Figure 1). The XD® Technology works in a continuous media feeding mode with a filtration unit to retain both the cells and the recombinant protein in the bioreactor. Compared with a standard fed-batch process, the feeding regime in the XD® process can be performed with basal media, and this allows straightforward implementation without the need for extensive…