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…

        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…

      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…

      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,…

      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…

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…

      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…

      BioPharma Solutions, a business unit of Baxter Healthcare Corporation, works with pharmaceutical companies to support their commercialization objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems, and customized support services needed to meet the unique challenges that parenteral products face.   Meeting Parenteral Manufacturing Challenges   Parenteral manufacturing can be a complex process. Cytotoxics, antibody-drug conjugates (ADCs), highly potent compounds, biologics, and lyophilized products require specialized understanding. BioPharma Solutions offers a dedicated facility with experienced…

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.…

      Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its broad portfolio of services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. Working with clients of all sizes, Covance recognizes that your development program is as unique as the product you bring to our facilities. With over 250 different biomolecules successfully supported annually, Covance…