2013

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…

From Bench Scale to Industrial Scale

Adherent cell processes for production of adenoviruses often involve 2D vessels that require many manual operations and large areas of cleanroom space, or microcarrier cultures that require complex cell transfer steps and a very high level of expertise. To maximize surface area within a compact space, Integrity® iCELLis® bioreactors contain macrocarriers trapped in a fixed-bed, providing ≤500 m2 of 3D growth surface area in only 25 L of fixed-bed. The iCELLis technology can be used at small scales (iCELLis nano…

Scale Up on Efficiency in Biologics Contract Manufacturing

Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with over 20 years of experience in microbial systems. Our customers benefit from a comprehensive service for the development of robust and highly efficient production processes and GMP-compliant manufacturing for clinical trials and commercial supply. Service Wacker Biotech’s services cover the whole process chain: from construction and optimization of host/vector systems to delivery of the bulk API. A well-equipped quality control department supports characterization of master and working cell banks and…

Development, Qualification, and Application of Single-Use Technologies for Bioprocessing

In the manufacture of biopharmaceuticals, single-use technologies are now employed throughout the workflow — from buffer and media preparation to bioreactor cultures for vaccines and biotherapeutics production as well as in the storage of those intermediates and bulk biologics. This diversity of applications adds to the difficulty in establishing appropriate testing and requirement specifications, as well as qualification and validation approaches. The integrity and performance of single-use systems depends primarily on the characteristics of the film, the largest component (and…

Avid Bioservices

Avid Bioservices is your CMO partner offering a suite of fully integrated, comprehensive biomanufacturing services that support the development and cGMP production of clinical and commercial-stage monoclonal antibodies, recombinant proteins, and enzymes. Our client’s success is our main focus. With over 15 years of experience, Avid provides services that support every phase of development: cell line optimization, process development, analytical methods development, clinical and commercial cGMP manufacturing, and regulatory support. As the wholly owned subsidiary of Peregrine Pharmaceuticals, a clinical-stage…