Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has introduced Sartoclear Dynamics, a clarification system featuring new single-use technology for harvesting mammalian cell cultures with high cell densities.
The GMP commercial launch manufacturing facility in Cranbury will focus on antibody biosimilars...
GE Healthcare Life Sciences and Rentschler Biotechnologie GmbH announced the expansion of...
The October issue of Pharmaceutical Processing describes Capsugel’s merger with Bend Research and Encap to create a comprehensive solid dosage form solutions group. The issue also features articles on supply chain trends including how to reduce risk, managing a clinical supply chain, a look at the best printing and coding solutions, and the move to the fully connected enterprise. Other articles focus on particle size analysis, disposable chromatography technologies, and monitoring potency assays.
Lonza Invests in Single-Use Technology and Facility Upgrades for Clinical Antibody Drug Conjugate (ADC) ManufacturingJune 11, 2014 8:34 am | News | Comments
The planned upgrades include the introduction of single-use technology for flexible ADC manufacturing, along with a recently optimized plant layout and revamping of the Heating, Ventilation, Air Conditioning (HVAC) systems, which has resulted in a larger ADC production area.
Nordson Corporation Expanding in Colorado to Meet Growing Demand for its Value Plastics Product Line in Medical End MarketsJune 10, 2014 9:22 am | News | Comments
Nordson Corporation has broken ground on a new state-of-the-art manufacturing facility, located on a 116 acre site in Loveland, Colorado, to meet growing demand in medical end markets for its Value Plastics brand of engineered, single-use plastic-molded fluid management components and to provide flexibility and capacity for continued long term growth.
The May issue of Pharmaceutical Processing profiles PCI, a contract developer and manufacturer of custom NCEs, fine chemicals and generic APIs based in Newburyport, MA. We also take a look at the critical success factors clients evaluate when choosing a CMO. Our manufacturing services Q&A discusses current trends, issues and the future of pharmaceutical processing services. In addition we cover tablet coating, single-use technologies and QbD in test method development and validation.
One of the reasons for the strong adaption rate of single use systems stems from the ability to implement such an approach at a number of different points in the production process. While there are still some limitations in terms of large-scale production, as the technology has evolved single use has translated to areas like mixing, purification, formulation and even filling as processors look to take advantage of the cost and time savings
GE Healthcare Life Sciences, and JHL Biotech today announced that GE Healthcare has completed installation of its FlexFactory™ biomanufacturing platform at JHL Biotech’s Research Center and manufacturing plant in Hsinchu, Taiwan. The new manufacturing platform will follow current good manufacturing practices (cGMP) and be fully operational by the end of 2013.
This first episode of The Daily Dose from Pharmaceutical Processing discusses the technology driving single use systems and why this methodology has had such an impact. Two specific benefits discussed here include limiting cross-contamination risk and reducing changeover times.
The ALpHA G is an absolute rated depth type prefilter, which has been optimized for compatibility with a gamma irradiation cycle commonly used to sterilize single-use systems.
The October issue of Pharmaceutical Processing profiles Catalent’s new clinical biologics manufacturing facility in Madison, Wisconsin. The role of quality control and microscopy services for the industry is also featured in this issue as well as an article on Brazil’s emerging pharmaceutical manufacturing industry.
The June issue is our annual Pharmaceutical Supplier Directory. Organized by product category this complete resource for the pharmaceutical manufacturing industry features detailed listings of the companies that supply products, equipment, systems, and services to the pharmaceutical industry. The 2013/2014 Supplier Directory is a must have for anyone involved in the development, scale-up, and manufacturing and packaging of pharmaceuticals.
There is a significant movement within the biotech industry to evaluate and implement single-use (SU) manufacturing systems in order to improve manufacturing efficiency, flexibility, and reduce costs.i The focus of many industry conferences and technical meetings centers on expanding the industry’s body of knowledge around SU system design and applications.ii
The journey from gene to clinic for a protein therapeutic is long and sometimes torturous, requiring a wide range of knowledge, expertise and capabilities. An industry-wide imperative to accelerate the journey with the same or fewer resources simply adds more pressure.
The landscape for equipment in the bioprocessing industry has changed dramatically in recent years. Once considered inferior to fixed, reusable equipment made of stainless steel and glass, single-use technology has since made great inroads into the market. While it may seem counterintuitive, moving from fixed reactors to those that are used once is actually more cost effective.
Parker Hannifin Corp. has announced the acquisition of SciLog Inc., a provider of unique and proprietary single-use technologies and systems for the biopharmaceutical market to support their on-going development as a key supplier to the growing single-use market.
Steam-Thru Connections from Colder Products Co., made of Polysulfone, are available in sizes that mate with 3/8-inch and ½-inch ID Tubing. Sanitary terminations are available in ¾ inch or 1 1/2 inch. They allow a quick and easy sterile connection between biopharmaceutical processing equipment and disposable bag and tube assemblies.
The new capabilities brochure highlights One-Touch® single-use systems. It gives an overview of each of the primary products within the single-use portfolio, including TepoFlex® PE and FluoroFlex® PVDF biocontainer assemblies.
The company, specializing in providing products and services to the vaccine production and bioprocessing industries, has launched PharmaTainer™ sterile single-use containers for storage, freezing and manipulation of biological solutions.
Single-use technologies are becoming increasingly common in many manufacturing situations, especially those that require high levels of sanitation and isolation for consumer safety. Although stainless steel offers a number of unique benefits, disposables are undoubtedly emerging as a leader in the high-stakes world of pharmaceutical manufacturing.
The company recently released an expansion to its disposable products portfolio with the new single-use mixing system, imPULSE. The single-use mixing system allows manufacturers to mix their powder/liquid or liquid/liquid solutions in an environment which eliminates cross contamination, requires less validation and efficiently requires shorter cycle times.
The company has expanded the Mobius® CellReady Bioreactor portfolio with the launch of a 50 L single-use stirred tank bioreactor for process development and pilot scale mammalian cell culture. This new single-use bioreactor allows biopharmaceutical manufacturers to implement robust, single-use technologies that bring their drugs to market faster, with less risk.
The company is launching its line of Single-Use Conductivity Sensors (patent pending), which will be offered in a wide range of sizes for in-line measurement, with an initial sizes of ¼-inch and ½-inch hose barb. The conductivity sensor measurement range is 0 to 200 mS with readability of 0.01 mS.
The company has introduced a technologically advanced series of ports for the single-use bags used to transfer media and drug compounds in the biopharmaceutical industry.
Today there is a continued accelerating evolution in CMO and traditional biomanufacturing to Single-Use Systems (SUS) and disposable technologies. While this term, ‘disposable’ has been used since the inception of the technology in the 80’s, the polymeric device manufacturers found the ‘single-use’ moniker a more ‘green’ label for their products.