Wednesday, August 1, 2012 Daily Archives

Automated, Nondestructive, Rapid Microbial Testing

Automated, nondestructive, rapid sterility and environmental monitoring () Rapid microbial testing methods continue to gain acceptance in pharmaceutical manufacturing, but experience shows that most companies still use traditional methods for their testing. The ability to deliver results in less time than traditional methods provides compelling benefits to manufacturers. Two key areas of microbial testing where these benefits can be realized include environmental monitoring and sterility testing. Microbial testing must be completed throughout the manufacture of pharmaceuticals, including the raw materials…

Althea Technologies, Inc.

      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 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 of the tangible benefits of consolidating your development and manufacturing steps, you’ll also have…

Scalable Packaging Systems for Cell Therapy

Daikyo Crystal Zenith® vials provide an ideal solution for low-temperature or cryogenic storage and transport of high-value biological drugs. () Many current cell-based products are produced, frozen, stored, and delivered to the clinical site in intravenous (IV) bags or polypropylene screw-cap containers. Although IV bags are sufficient for small-scale processes, they may not be suitable for commercial scale. Bag failures can lead to microbial contamination of the cell product, increased product preparation time, increased antibiotic use, and increased resource expenditure…

Culture of Normal Human Dermal Fibroblast Cells

      The large numbers of ex vivo expanded cells that are required in many clinical cell therapy protocols (>100 million per patient) make standard culture conditions problematic and expensive, resulting from the need for extensive personnel and facilities resources and the high potential of contamination. To meet such clinical demand, a robust, automated, and closed cell-expansion method is optimal. The Quantum Cell Expansion System (CES) is a functionally closed, automated, hollow-fiber bioreactor system designed to reproducibly grow both…

Managing the Challenges of Cell Therapy Product Delivery in Clinical and Commercial Settings

      Unlike traditional pharmaceuticals, cell therapy products (CTPs) require geographically dispersed networks of cell/tissue collection, manufacture, distribution, and clinical treatment facilities. Regardless of source (allogeneic, autologous) or formulation (e.g., fresh, frozen, scaffold), the vast majority of CTPs are clinically administered on a per-patient basis. A CTP will be clinically effective, and therefore commercially viable, only if it is robust enough to be delivered to the patient in an efficient, controlled, and reproducible manner. In the context of CTPs,…

New EXP-Pak™ Closed-System Disposable Cell Expansion Bags

      Clinical cellular therapy applications often times require a cell expansion or maturation step before use. Traditionally, cell expansion or cell culture is performed in “open” systems including multiwell culture dishes or tissue culture flasks. These “open” steps present risks and are not ideal for larger-scale manufacturing. The new EXP-Pak™ cell expansion container is a closed-system, gas permeable bag intended for expansion and culture of nonadherent cells. EXP-Pak™ bags are made from a unique polyolefin film that permits…

SoloHill Microcarriers in a 25-L PadReactor™ Single-Use Bioreactor

        The purpose of this study was to demonstrate compatibility and performance of SoloHill’s Collagen-coated microcarriers in ATMI Lifesciences’ Integrity™ PadReactor™ system. The solid polystyrene core of the collagen microcarriers prevents absorption of serum or cell products into the core of the microcarrier, and the 1.03 specific gravity and 125- to 212-μm diameter allows them to be maintained in suspension with gentle low stirring speed. These solid microcarriers provide an excellent substrate for cell growth. They can…

ALLpaQ

      At ALLpaQ, we’ve enjoyed 12 busy months designing and supplying folding plastic bioprocess containers to the pharmaceutical and biotechnology industries. Thinking outside the proverbial bioprocess box, we’ve also responded to customer demand by growing our consultancy arm. This means we can design your organization’s whole containment needs from start to finish, saving you time and money along the way.   Our Knowledge Is Your Power   With 10 years’ experience developing the preeminent range of plastic large-volume…

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 assist 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…

Grade, Range, and Format

      In pharmaceutical and biochemical manufacturing processes, the emphasis is on knowable quality levels, defined components, and predictable, repeatable yields and products. This underlines the importance of reliable specification and quality claims, whether they point to cGMP, molecular biology grade, high purity, or simpler grades. The point is to be what they are claimed to be. Naturally, it is not a question of the highest purity possible, but rather the highest purity necessary at a cost that makes…