Figure 1: Biological drugs are an increasingly important and growing part of the pharmaceutical industry but are associated with a number of challenges that have constrained their application. The lack of efficacy due to short protein half-life and/or poor availability is an issue that leads to a requirement for both high and frequent dosing (Figure 1). Such administration demands can result in unwanted side effects and limit the therapeutic benefits, as well as elevated patient dosing that creates an extra…

    Figure 1:   SterilEnz®-II/G connectors and SterilEnz Samplers represent a novel design improvement when compared with common fittings and fluid injection sites. This article briefly discusses the features, benefits, and technical aspects surrounding the design and integrity testing of the SterilEnz product line as well as advantages over their predecessors.   SterilEnz-II/G Flange Connectors and Samplers   Each SterilEnz-II/G connector is hermetically sealed inside a rugged overwrap pouch (Figure 1). The connector is fitted with a pre-attached, medical…

    Figure 1:   Full-length antibody biopharmaceuticals continue to capture significant market due to their validated effectiveness as specific therapeutics. However, more recently it has been recognized that full-length antibodies may not always be necessary because antibody fragments can provide opportunity for new therapeutics with less complicated, higher-yielding production processes such as Escherichia coli and yeast microbial systems. For full-length antibodies, the downstream processing is facilitated by use of protein A–based affinity adsorbents for capture and initial purification; however…

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…

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…

    Figure 1:   During the past few years the biotech industry has started to move away from protein A-based platform systems for MAb purifications. The high cost of protein A resins, their modest dynamic binding capacities (DBC), and their limited base stability place restrictions on a developmental engineer’s ability to reduce process costs and improve throughput for a given plant footprint. Recent literature reports from Percivia (1) and Medarex (2) have described the use of improved cation exchange…

Orbital welding has long been the most popular and accepted method for joining 316L stainless steel tubing within the bioprocessing and pharmaceutical sectors. Yet as requirements for orbital welding continue to expand, so does the need to select a system that will pay dividends in more ways than one. Recent advancements in small, portable inverter power supplies help improve the consistency and reliability of welds as well as operator efficiencies. Open Platform Design To enable optimal efficiencies, a power supply…

Advanced Scientifics is a leader in the design and manufacturing of single-use systems for the pharmaceutical and biotechnology industries. The company offers a multitude of solutions for flexible containers. Numerous films are available such as polyethylene (PE) and ethyl vinyl acetate (EVA) bags, as well as C-Flex, Silicone, PVC, and PharMed BPT tubing types. With sizes ranging from 50 mL to 2,500 L, Advanced Scientifics can produce single-use containers of nearly any configuration as well as multiple porting options with…

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 a large west-coast biotech company 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 competitors. Applikon has kept its focus on the bioreactor and anything related…

Figure 1: ATMI® LifeSciences offers five different disposable mixing technologies that provide varied cost, operational, and performance advantages over conventional stainless steel mixing vessels and competing disposable mixers. Criteria for selecting the best ATMI mixing technology include scale, particle, and sheer sensitivity, mixing power, physical fit, and economic considerations. This application note illustrates how the LevTech® Magnetic Mixing system performs in a demanding media mixing application. Introduction The LevTech Magnetic Mixer is a compact and noninvasive single-use mixing system. The…