August 2013

Labfors 5 with LabCIP

Table 1:&#8 The need for a rapid turn-around in quantity (and the loss of technicians in many laboratories) has created a trend toward single-use vessels. Their advantages include no time lost in cleaning or sterilization (especially for bench-scale, autoclavable systems), no chance of inhibition or cross-contamination due to poor cleaning, and no need for cleaning and sterilisation facilities in a crowded laboratory. For production-scale steel bioreactors, fully automated clean-in-place (CIP) and sterilization-in-place (SIP) has been possible for decades. By contrast,…

Large-Scale Expansion of Hepatic Progenitor Cells

Cell therapy is offering a promising future in medical advances. Although multilayer trays are suitable for R&D and preclinical cell amplification, they cannot support large-scale industrial production. A successful transition from laboratory scale to an efficient and robust process based on good manufacturing practice (GMP) is key. The Integrity® Xpansion™ multiplate bioreactors have been specifically designed to enable an easy transfer from existing multiple-tray stacks processes by offering the same cell growth environment on two-dimensional (2D) hydrophylized polystyrene (PS) plates…

Sandoz: Provider of Customized Solutions in Biotech Manufacturing

Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than two decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offers a broad variety of integrated services including innovative expression systems, process development, scale-up, and production of recombinant products derived from microbial systems and mammalian cell culture in state-of-the-art facilities. Our expertise is based on numerous projects successfully performed in collaboration with our customers. Currently, Sandoz is…

Large Scale CHO Transient Gene Expression Using Flow Electroporation

Researchers have turned to Chinese hamster ovary (CHO)–based transient gene expression (TGE) as an alternative to CHO stable cell line production for early stage antibody development. Despite advances in transfection methods and culture optimization, most CHO-based TGE systems produce antibody titers (low mg/L) that are insufficient for full use in biotherapeutic development pipelines. MaxCyte electroporation is a universal, transient transfection platform with unmatched quality, flexibility, and scalability and the capacity to transfect up to 2 × 1011 cells in under…

From Concept to Completion

Ajinomoto Althea is a contract developer and manufacturer of biopharmaceutical and injectable products, with fully integrated product development and CGMP manufacturing expertise to support client projects from preclinical development through commercial supply. Each project program at Ajinomoto Althea is tailored to the specific needs of your product, allowing you to leverage our entire integrated manufacturing approach or just the parts you need. While realizing all the tangible benefits of consolidating your development and manufacturing steps, you’ll also have the confidence…

Passion for Your Process, Product, and Patients

Contract manufacturing of biologics is more than having superior technology — it’s having experienced people who are passionate, responsive, and committed to developing and manufacturing your biotherapeutics to improve patient care. As a fully integrated contract development and manufacturing organization (CDMO), Therapure Biomanufacturing has the scientific and technical expertise to successfully deliver at every stage of product development (preclinical, clinical, and commercial). Our 130,000-ft2 (12,000-m2) CGMP manufacturing facility meets FDA, EMA, and HPFB regulatory standards and includes flexible clinical and…

Disposable Components

Disposable Clamps Qosina offers slide clamps, pinch clamps, and roller clamps in an assortment of sizes, colors, and styles. In stock and available for immediate delivery, these disposable clamps are available to fit tubing dimensions ranging from 0.06 inch OD to 0.75 inch OD. Material selection consists of polyacetal, polypropylene, polycarbonate, ABS, PVC, and many more to meet your needs. In addition, Qosina also carries clamps in a variety of sizes, styles, color, and materials, including closure clamps, catheter clamps,…

Contract Test Service

Associates of Cape Cod,® Inc. Contract Test Service (CTS) laboratory specializes in method developement, bacterial endotoxin testing (BET), and glucan contamination. With the most extensive experience of any endotoxin testing laboratory in the world, CTS is GMP compliant, ISO registered, and licensed by the US Drug Enforcement Agency (DEA) as a laboratory capable of handling all controlled drug substances except those included in Schedule I. Endotoxin testing can be performed in accordance with US Food and Drug Administration (FDA), United…

Vetter Development Service

Vetter, a leading provider of aseptically prefilled drug-delivery systems, operates a state-of-the-art facility at the Illinois Science + Technology Park in suburban Chicago, IL. The site offers a central US location with a domestic and international airline hub. It is uniquely situated in a thriving biopharmaceutical region that offers an established infrastructure and prominent research institutions. The company’s Chicago site supports preclinical through phase 2 development projects. The 27,000-ft2 facility’s functional areas include microbiology and chemical analysis laboratories; materials preparation;…

Optimizing Your Media

Figure 1:  For more than 65 years, Kerry’s Sheffield brand has earned its reputation for reliability and excellence in serving the biotech, pharmaceutical, and nutrition markets. We deliver innovative, animal-component– free supplements to help customers increase cell proliferation, extend cell viability, and increase target protein production. Every day we expand our capabilities to meet the changing needs of the biotech market by providing the industry’s most innovative and extensive biotechnologies, including complete supplement systems, hydrolyzed proteins, recombinant proteins, and yeast…