August 2011

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…

3-L to 2,500-L Single-Use Bioreactors

          PBS Biotech® makes the industry’s most advanced single-use bioreactors. With low-profile, easy to use, and plug and play designs, these systems range from 3 liters to 2,500 liters permitting fully scalable bioprocess solutions from benchtop to production. At PBS Biotech we provide bioprocess solutions. We work with each customer to develop a tailored, single-use bioreactor plan that delivers optimal value in your bioprocess and provides competitive advantage and value that is developed, applied, and measured.…

Viral Clearance Services at Lancaster Laboratories

The risk of viral contamination is a feature common to all biotechnology products produced by processes that use cell lines and raw materials of animal origin. Such contamination could have serious clinical consequences, and worldwide regulatory bodies expect that the viral safety of these products be ensured. Viral clearance studies are performed as one way of demonstrating viral safety. The studies are executed by intentionally adding or “spiking” large amounts of virus into the starting material for individual manufacturing steps…