August 2011

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…

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…

Maximizing Gas-Transfer in Small-Scale Cultures

Research and early process development generally rely heavily on screening and examination of cultures grown in microtiter and shake-flasks. Unfortunately, the growth environment in these formats is extremely different from the bioreactor conditions used in larger-scale production. This application note describes two tools for improving growth conditions at these scales. Theµ-Flask: Cultures grown in traditional microplates are usually sealed using simple plastic lids or adhesive tape seals. Such systems suffer from well-to-well variability, poor gas transfer, excessive evaporation, and cross-contamination.…

Formulation and Fill for a Vaccine with Alum Adjuvant

The goal: Develop a CGMP formulation–fill process for a subunit vaccine–aluminum adjuvant complex. The challenge: To engineer a scaled-up process for vaccine–adjuvant suspension formulation and fill, ensuring a uniform fill per dose as well as a sterile product. The Outcome: Florida Biologix scientists successfully developed the manufacturing, formulation–fill process and test methods. The process was conducted successfully in a scaled-down engineering run and at full scale, and 2,500 vials were tested, released, and shipped to the clinic on time. About…