Recipharm Biologics is part of Recipharm AB of Sweden, one of Europe’s leading contract development and manufacturing organizations. Privately owned and financially robust, Recipharm specializes in providing customers with a full-service, one-stop-shop approach — from formulation and analytical development through to commercial manufacturing. We employ some 1,400 people and have been operating since 1995. With manufacturing facilities located in Sweden, France, the United Kingdom, and Switzerland, we can handle a wide range of dosage forms including solid dose, sterile (liquids…

      Rentschler Biotechnologie GmbH is a full-service contract manufacturer with over 30 years of experience in the development, production, and approval of biopharmaceuticals in compliance with international GMP standards with a highly skilled staff of 450. As part of the Rentschler Group and headquartered in Laupheim, Germany, Rentschler is one of three leading European CMOs operating globally. Dedicated to delivering high-quality biopharmaceuticals produced in mammalian cell culture, Rentschler has nine stand-alone GMP suites with volumes of 30 L,…

Pressure is bearing down on all sides. Pharmaceutical and biotechnology companies face stress from increasing costs, intensifying global competition, growing regulatory stringency, and more. For years, they have relieved a little of this pressure by outsourcing functions to a limited extent, such as packaging or distribution. Allowing a contract manufacturer to perform some operations frees up companies to focus on their core competencies. Today, however, some of the industry’s most eye-opening success stories are the result of even more extensive…

    Figure 1:   Due to potentially very dangerous flu outbreaks in recent years, the need for production of influenza vaccines in sufficient quantities has been expressed. Also, the time needed from vaccine design to the market and overall process efficiency needs to be improved. This, along with drawbacks of the traditional viral vaccine production in embryonated chicken eggs, has led to the use of reverse genetic techniques and cell-culture–based virus propagation. Because existing downstream processes of virus purification…

    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:   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…

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…

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…

Biopharmaceutical manufacturers face increased pressure to commercialize new drugs faster and at a lower cost. To meet existing and future demand and maintain a competitive advantage, many manufacturers are striving to develop increased efficiencies within their manufacturing processes. This is where single-use systems — particularly single-use transfer lines — can deliver significant value, including added flexibility, improved production yields, and increased cost savings. The trend today is toward transfer lines or tube sets that use single-use connectors and filters to…