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.
Alvotech today announced plans to invest $250 million in the development and manufacturing of a...
Our annual reader survey looks at issues facing innovator companies and the CMO/CSOs that...
JHL Biotech, Inc., a provider of biopharmaceutical process development and manufacturing...
Zogenix, Inc. and Battelle have entered into a new long-term collaborative agreement regarding co-marketing of Zogenix's DosePro(R) needle-free drug delivery technology, advancing potential out-licensing opportunities for DosePro with biopharmaceutical clients, and expanding the application of the technology to higher-dose biologic therapies.
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.
Mylan has announced that its partner Biocon has received approval for a Mylan-Biocon trastuzumab product from the Drug Controller General of India. This is the first regulatory approval for a Mylan-Biocon developed biosimilar product. The product is a biosimilar to Roche's Herceptin, indicated for the treatment of HER2 overexpressing breast cancer.
These cryogenic valves are suitable for high-pressure, low-temperature liquified natural gas (LNG), manufacturing, heat treating and vaporizing applications to -420F.
These microprocessor-controlled PCR workstations reduce risk of sample contamination during DNA/RNA amplification and manipulation.
This new device is designed to meet the demand for more flask clamp sizes suitable for holding a wider variety of sample sizes.
This mechanical self-setting valve switch reduces calibration time, especially during instances of diaphragm change-out and valve commissioning.
The compact, multiport double weir design of this diaphragm valve provides for multiple flow paths while reducing contact surfaces and hold up volume.
Each of these ductless chemical fume hoods has advanced safety monitoring and controls and is ASHRAE 110 tested.
These biocontainers provide fluid integrity performance in 2D & 3D configurations, in volumes from 50 mL to 1,000 L, to accommodate R&D through production needs.
RQC Series flexible tubing connectors are designed for single use systems.
Biosimilars have received a lot of attention and “buzz” lately. And, as the FDA continues to hold meetings and put out documents for comment as it decides just how to eventually approve and regulate these biopharm generics there is one question that needs to be addressed.
The FDA/EMEA has introduced initiatives to advocate real-time, in-line monitoring of critical parameters in the manufacturing process, rather than testing the end product. This article discusses the application of a new sensor technology which provides real-time insight into nutrient consumption and product expression enabling manufacturers to automate and optimize closed loop control of the feeding regime of their media.
Amgen will focus on the integration and strategy behind its acquisition of Onyx Pharmaceuticals, which makes two cancer drugs and has others in testing, when it reports third-quarter results late Tuesday.
Biopharmaceuticals continue to be a growing, important class of pharmaceutical products on the market, and many of these products are produced using mammalian cell culture. Monoclonal antibodies, currently the dominant class of biopharmaceuticals, generally require mammalian cell culture production to enable addition of critical post-translational modifications such as glycosylation.
Amgen and ShanghaiTech University today announced the two organizations have entered into a memorandum of understanding (MOU) to form a strategic partnership for the advancement of biopharmaceutical discovery and translational research in China. This agreement includes plans for Amgen to open a China research and development (R&D) center at ShanghaiTech University.
GE Healthcare Life Sciences to Build KUBio Modular Biopharmaceutical Factory for JHL Biotech in ChinaSeptember 25, 2013 8:07 am | News | Comments
GE Healthcare Life Sciences and JHL Biotech, a provider of biopharmaceutical process development and manufacturing services, today announced that a KUBio ™ modular biopharmaceutical factory will be built in China for JHL Biotech. The site for the new factory, which will be fully operational beginning early 2015, is the Biolake Science Park in Wuhan, China.
The September 2013 issue of Pharmaceutical Processing features a profile of LSNE, a Bedford, NH-based contract manufacturing company that offers a range of lyophilization and fill/finish services. We also take a look at how CMOs are evaluating employee performance to improve operations, and our article on parenteral manufacturing services details some new trends for this important market segment.
The foundations of the biosimilar drug market continue to take shape as drugmakers move forward with their varied and evolving strategies for biosimilar pharmaceutical development, according to a new Fitch Ratings report. The opportunities afforded by the nascent biosimilars market are significant as eight of the 20 best-selling pharmaceutical products in the world are biologics set to lose patent protection by 2020.
Bristol-Myers Squibb Company and Samsung BioLogics today announced the companies have entered into a 10-year agreement under which Samsung BioLogics will manufacture a commercial antibody cancer drug for Bristol-Myers Squibb at its recently completed plant in Songdo Incheon, South Korea.
Don’t you just love it when things work? When that “gadget” that you have been looking at and have researched turns out to work exactly as promoted?
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.
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