As drug development continues to increase complexity, so do the primary packaging solutions that are being employed. Primary containers are no longer to considered as inert components whose sole function is to contain a drug product, but rather as an integral part of a drug delivery system.
Half of biopharma companies now have a Metadata Management project under way, according to a...
IPS-Integrated Project Services a leader in developing innovative and cost effective solutions...
New development technologies, expanded contract manufacturing and service capabilities, as well as innovative equipment investment strategies highlight leading practices from the best in pharmaceutical processing comprise the 2014 Pharmaceutical Processing Facility Excellence Award winners.
Olympus Biotech today announced the initiation of an aggressive transaction process to find a buyer of its West Lebanon, NH manufacturing facility over the next 90 days. In recent months, the Company has received interest from buyers and contract manufacturing organization (CMO) partners, but no deal has been consummated yet.
The Jan/Feb 2014 issue of Pharmaceutical Processing is our INTERPHEX 2014 Preview issue and features numerous exhibitor highlights and a guide to the educational conference program. In addition, we profile Xcelience, a clinical trial material contract manufacturer based in Tampa, FL.
The use of disposables in biopharmaceutical production facilities started in the late 1990’s and has evolved to include innovative Single-Use Systems (SUS) products from upstream bioreactors/clarification filtration to downstream separation and purification applications, TFF, membrane chromatography, and virus removal.
Allegro single-use mixers are part of the company's expanding range of Allegro products and services providing integrated process solutions throughout the drug production process. The Allegro mixers combine critical requirements for single-use technologies, such as extreme ease-of-use, with established engineering principles and criteria for robust mixer design to deliver the ultimate in mixing performance.
BioPure single-use tubing connector systems simplify production operations, lower costs of GMP Pharma manufacturing and reduce process validation time. Peristaltic pumps contain fluid to be pumped ensuring isolation from any source contamination.
This single-use line of four-piston diaphragm pumps is designed for utilization in biologic-handling applications within pharmaceutical and biotech operations. The Quattroflow product line consists of five pump sizes—QF150, QF1200, QF4400, QF5050 and QF20K—with capacities between 1 and 20,000 L/hr (5,283 gph).
The Saltus® M200 is a 200 L single-use mixing system for biopharmaceutical manufacturing processes, powder-liquid and liquid-liquid mixing.
GE Healthcare has a range of integrated solutions that comprise products, platform technologies, and services designed to enable efficient and robust bioprocess manufacturing. ReadyToProcess™ suite of modern disposable manufacturing products enabling flexible manufacturing strategies.
Participate in the bio-industry's most in-depth, global study: 11th Annual Biopharmaceutical Manufacturing Report and Survey.
Emergent BioSolutions has entered into a definitive agreement with Cangene Corporation under which Emergent will acquire all of the outstanding common shares of Cangene in an all-cash transaction valued at $3.24 per share on a fully diluted basis for an aggregate purchase price of $222 million.
When considering the purchase and implementation of single-use technologies there are many variables to evaluate. One important consideration is how the new single-use systems will integrate with the existing facility infrastructure.
Inadequate maintenance and monitoring programs for compendial water systems can result in chemical and/or microbial excursions that impact water quality. Total viable bacteria results associated with distribution loop sampling are not available for at least 3-5 days after collection. During this time an unacceptable increase in total viable bacteria could occur as a result of an operating excursion in a water purification unit operation.
Navidea Biopharmaceuticals announced today that the FDA has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.
Our annual reader survey looks at issues facing innovator companies and the CMO/CSOs that support them.
JHL Biotech, Inc., a provider of biopharmaceutical process development and manufacturing services, and Switzerland-based Selexis SA, a provider of technologies for mammalian cell line development, announced today that they have signed a non-exclusive strategic agreement to provide biopharmaceutical customers a seamless solution for the development and cGMP manufacturing of biologic drugs.
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.
Ready-to-go straight from the box, ÄKTA start is a compact, affordable protein purification system that removes the hassles of manual approaches and provides automated control of the purification procedure.
Stratus Media Group, Inc., announced today the closing of its acquisition of two biopharmaceutical companies - Canterbury Laboratories, LLC, and Hygeia Therapeutics, Inc.
BioValves are designed to minimize flow path turbulence and be used single handed. Molded from glass reinforced Nylon USP Class VI, the thread pitch is calibrated to 2mm per turn, ensuring accurate fluid transfer rates.
The Bio Tube Applicator is a pneumatic device enabling operators to effortlessly connect barbs, filters and other single use components, at the touch of a button. The unit eliminates the need for alcohol based lubricants in assembly while potentially reducing the risk of operator repetitive strain injuries by removing the need for manual force.
These cryogenic valves are suitable for high-pressure, low-temperature liquified natural gas (LNG), manufacturing, heat treating and vaporizing applications to -420F.
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