Peter Hanson, IPS' Director of Process Architecture, Asia and EMEA talks about changes in biopharmaceutical design for facilities in these emerging markets including shifts in investments and the types of investments.
Half of biopharma companies now have a Metadata Management project under way, according to a...
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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.
In the biotechnology and pharmaceutical processing industries, maintaining diaphragm valves is considered the primary bottleneck of the maintenance process. A typical diaphragm change-out can easily take a full week of plant downtime, resulting in significant hours of lost production time.
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.
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.
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 portfolio of biosimilar monoclonal antibodies. Alvotech’s current biosimilar assets include follow-on versions of leading monoclonal antibodies molecules, which will be brought to market by 2018.
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.
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.
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