A Comprehensive Solution         Innovative Viresolve Pro Family: Robust, productive, next generation Quality and Manufacturing Expertise: Over 15 years of virus filter manufacturing experience; state-of-the-art membrane plant; comprehensive validation; raising the standard of performance and integrity tests Industry-Leading Service and Support: Process development, optimization, and scale-up; leading the industry with spiking strategy and validation; services covering every stage of adoption   Building Assurance Test By Test (Figure 1)   No one does more than Millipore to…

          Mycoplasma is known to be a common source of bioprocessing contamination and one of the most difficult contaminants to detect. The effect of a mycoplasma contamination can be catastrophic, resulting in loss of a batch, loss of future production, down-time for investigation and corrective actions, and the potential risk of therapeutic supply shortages to immunocompromised patients. To demonstrate Millipore Express SHR filters’ mycoplasma clearance capability over extended filtration times, two separate Acholeplasma laidlawii retention studies…

          In the pharmaceutical industry, there is a strong desire to introduce new drugs on the market as fast as possible (time-to-market) due to time-limited patent protection for new pharmaceutical products. The thinking behind this desire is simple: the sooner a new product can be introduced to the market, the sooner patients can benefit, and the better are the manufacturer’s prospects of financial returns. This consideration, however, should not allow compromises to enter into the manufacturing…

          Albumin and albumin-related proteins such as albumin fusion proteins represent an increasingly important platform for production of therapeutic proteins with extended in vivo half-lives. Affinity ligands directed to the albumin portion of the molecule are ideally suited to development of a purification platform for albumin containing proteins. In addition, significant reductions in manufacturing costs are possible, especially if processing times can be shortened through use of higher flow rates.   Introduction   Mimetic Blue® SA…

          The demand for biopharmaceutical products, in particular, monoclonal antibodies (MAbs), is rapidly increasing during recent years. The necessity for pharmaceutical companies of being first to market combined with the need to cut development costs makes the application for high-throughput screening (HTS) techniques and tools in downstream process development indispensable. Atoll’s 96 MediaScout® RoboColumn® array together with Tecan’s Freedom EVO® liquid handling workstation enables fully automated parallel column chromatography for the first time. The RoboColumn® design…

          Chromatographic resins for a new purification process are initially selected based on prior experience and knowledge of the feedstock and the target compound. As the process scales larger, and hopefully through therapeutic commercialization, developers seek opportunities to maximize throughput, remove impurities, and reduce cost. Responding to the dramatic increase in batch titers over the past decade, products such as the Toyopearl GigaCap series of resins (first introduced in 2007) were developed to meet the titer…

          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 associated 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…

          At a time when most companies endure the effects of a global economic melt-down, ALLpaQâ„¢ seizes the opportunity for growth on the international stage. ALLpaQâ„¢ Packaging Ltd. develops, manufactures, and supplies standard and custom bioprocess containers for the storage, transportation, and handling of biopharmaceutical fluids on both three-dimensional (3D) and two-dimensional (2D) design platforms. During the past twelve months, ALLpaQâ„¢ has emerged as a strong contender on the world stage in providing packaging solutions to…

          Applikon Biotechnology is the world’s leading manufacturer of glass autoclavable vessels. Over 25 years ago, autoclavable vessels were sold as systems by many companies. When large west-coast biotech companies wanted a modular approach and also wanted changes in the design of the vessel, Applikon listened and complied. The glass bioreactor is now the standard of the industry and is sold in similar forms by many of Applikon’s competitor. Applikon has kept its focus on the…

          Efficient movement and storage of liquids is critical to modern biotechnology processes. The deployment of single-use containers for this task has become ubiquitous in recent years because they reduce risk while driving down costs in comparison with traditional stainless steel equipment ATMI’s integrity 2-d and 3-d Bioprocess vessel (BPV) products have been developed to meet the demand for cost-effective, scalable, single-use liquid storage containers that are compatible with ATMI’s market-leading range of single-use mixing and…