The global biotechnology industry rebounded strongly in 2013, with public companies achieving double-digit revenue growth and a sharp increase in funds raised. However, much of the industry's growth was driven by a relatively small group of commercial stage companies, increasing the urgency for the rest of the industry to achieve greater efficiency in their drug development efforts.
Researchers at the University of Michigan have obtained the first three-dimensional snapshots of...
The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics...
A global analysis of 238 biomanufacturers and 178 suppliers in 31 countries — the 514 page study...
Ipca Laboratories Ltd., India and Oncobiologics, Inc., USA announced today the creation of a two-part alliance for the development, manufacture and commercialization of biosimilar monoclonal antibody products.
The April issue of Pharmaceutical Processing profiles Reed-Lane, a contract packager of solid-dosage products based in Wayne, NJ. Additional articles on contract services and outsourcing topics include a look at the global biosimilars market and an update on solid dosage manufacturing services. In addition, the benefits of using ready-to-fill vials is explored. Other topics covered in this issue include packaging inspection, anti-counterfeiting technologies, lab design and expediting drug development.
Applikon Biotechnology will open a new production facility on Wednesday March 19th in Guangzhou, China. The opening ceremony will be combined with a scientific seminar “Innovations in bioreactor technology”.
The March issue of Pharmaceutical Processing is our INTERPHEX 2014 show issue and features numerous highlights from show exhibitors. In addition, we also announce the winners in our new Facility Excellence Awards program.
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 survey conducted by SOA Software. This finding shows that metadata management is emerging as a compelling solution for many biopharma businesses.
IPS-Integrated Project Services a leader in developing innovative and cost effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities has announced four presentations to be given by the company’s subject matter experts during INTERPHEX 2014 in New York City.
The Caliber Biotherapeutics manufacturing facility in Bryan, Texas offers an interesting look at the development and integration of Plant Made Pharmaceuticals. This commitment to new and innovative drug development strategies has led to it being recognized as one of Pharmaceutical Processing’s Facility Excellence Award winners for 2014.
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.
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.
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