CRM197 is a nontoxic mutant of diphtheria toxin containing a single amino-acid substitution of glutamic acid for glycine. CRM197 is a well-characterized carrier protein used in a number of approved and highly successful conjugate vaccines including Pfizer’s Prevnar® pneumococcal vaccine, a multibillion-dollar franchise; HibTiter® (Haemophilus influenzae b) vaccine, and Novartis’ Menveo® meningococcal vaccine. Traditionally, CRM197 is produced by fermentation of a Corynebacterium diphtheriae C7 (β197) tox (–) strain, which secretes it into the culture supernatant. It is then recovered after…

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…

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…

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…

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…

Bosch Packaging Technology has been supplying the pharmaceutical industry with final fill solutions for over 30 years. During that time, Bosch has continued to focus on quality and industry-leading customer-focused solutions that provide the best return on investment over time. Filling Systems Bosch is the premier supplier of final fill–finish solutions to the pharmaceutical industry. As a single-source supplier with the industry’s widest portfolio of solutions, Bosch can supply the type and scale of equipment you require. We offer systems…

Expertise Cobra Biologics is a rapidly expanding international contract manufacturing organization (CMO) of biologics and pharmaceuticals for clinical and commercial supply. Cobra has three good manufacturing practice (GMP) approved facilities, each with expertise tailored to serving our customers across the world. We offer a broad range of integrated and stand-alone contract services, stretching from cell line and process development through to fill and finish for the supply of investigational medicinal products and commercial production. Experience For over 15 years, we…

The commercial prefilled syringe line at Cook Pharmica can process up to 600 syringes per minute, 36,000 syringes per hour, or 70 million syringes per year. The automated, high-speed syringe line is fully enclosed in a barrier isolator to provide the highest level of aseptic processing available by removing the human element from the entire process. With the ability to operate in smaller batches or full-scale campaigning, the prefilled syringe line is capable of bridging clinical programs into commercial production.…

Mesenchymal stem cells (MSCs) are an attractive target for clinical study as therapeutic agents. However, current multilayer flatbed culture-expansion paradigms are cumbersome, time consuming, and typically limited in the ability to monitor cell characteristics during the growth process. We have used the Mobius® CellReady 3-L bioreactor in combination with microcarriers and human mesenchymal stem cells (hMSC) as a model. Following expansion, we have comprehensively compared the characteristics of cells grown in the bioreactor with those grown in standard two-dimensional (2D)…

Georgia’s strong and growing fill and finish sector includes access to an extremely talented workforce and world-class global infrastructure for cold chain, logistics and transportation. World-Class Distribution and Logistics Infrastructure Cold-Chain Storage in Georgia 70 cold-chain facilities 90% of the top 25 global third-party logistics providers (3PLs) Operations for four of the top five global public refrigerated warehousing companies Four major US interstates enabling companies to reach 80% of the US market by truck in less than two days Georgia…