FROM THE EDITOR
If the method used to determine whether or not a protein is a viable target for drug development were improved, pharmaceutical companies could potentially avoid the losses associated with finding out too late that a drug has harmful side effects and/or a lack efficacy. So how can pharma do this? Well, fortunately for them, some new technologies are now available to enhance their ability to select and evaluate safer targets in improved cell systems.
The Next Generation Drug Delivery Devices
An exciting trend in drug delivery is underway: the movement toward smaller, smarter, wirelessly connected electronic devices that allow patient-administered therapy. Inspired by the technological advancements driving the consumer electronics market, new methods for drug delivery show great promise for all stakeholders.
Wireless Dose-Compliance Monitoring In Drug-Delivery Devices
Incorporating wireless technology into medical devices is about more than just keeping up with the hottest technology trends; the benefits are real and significant, especially with regard to monitoring and encouraging dose compliance in the pharmaceutical and medical realm.
The Next Generation of Drug-Delivery Devices
Drug-delivery markets are moving toward smaller, smarter, wirelessly connected electronic devices that permit patient-administered therapy Smart technology, when applied to drug-delivery, describes the new electromechanical operation, and the self-administration of drugs by the patient. Related smartphone and tablet apps for multi-device integration are also made available. Advantages of smart drug-delivery include improved therapies, reduced costs, increases patient compliance, and better health outcomes.
Best Practices In Supply Chain Management: A CMO Perspective
Supply chain management has advanced rapidly over the past decade, evolving from what was once dubbed “materials management” into the essential glue that binds all aspects of a business’ internal and external collaborations.
Key Considerations When Choosing A Partner For Drug Discovery
The changes in the economic landscape and pipelines over the last 10-15 years have resulted in drug developers in companies of all sizes to take a hard look at their strategy and operations.
Losing Everything: Are Chart Recorders Enough?
Perhaps, unfortunately, this scenario is all too familiar: You arrive at work on Monday morning and hear an alarm sounding from your refrigerator. You walk over to your fridge to check the chart recorder and see abnormal spikes on the paper graph, but a detailed analysis by quality control personnel is required to take any action whatsoever. You find out that the chart doesn’t show enough data for a quality-based decision, so the product inside has to be discarded. Panic sets in. The monetary value of the supplies pales in comparison to the fact that patients today are relying on the medicine inside.
BIOPROCESS CONTRIBUTING EDITORS
How Califf As FDA Commissioner Could Benefit Biosimilar Market
There are still many key decisions that the FDA needs to make when it comes to biosimilars. Why should we feel optimistic that Califf is the man to make them?
Is Pharma Competitiveness Obscuring The Biosimilar Market’s Potential?
There is no shortage of research reports in the pharma industry forecasting the potential success or failure of emerging therapeutic markets. However, considering the pharma industry seems to have erupted into a civil war over whether or not the market will be as successful as predicted, it is difficult to get a sense of where the market is actually headed.
Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market?
Last week, Matthew Herper of Forbes published an eye-opening article providing a closer look at FDA approvals in recent years, coming to the conclusion that the industry is facing what could be a dangerously high approval rate for new drugs. But how could high approval rates be a bad thing?
FDA Releases Long Awaited Guidance On Biosimilars Naming
After months of debate between reference product makers and generic manufacturers, the FDA released its long-awaited guidance proposing a naming strategy for biosimilars.
Could AbbVie Hurt Itself With Biosimilar Labeling Demands?
In May, the FDA changed its stance on several key points of its draft version of the “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.” In accordance with these changes, any biosimilar licensed under the PHS Act § 351 (k) no longer needs to contain a statement on its label indicating that it is a biosimilar.
HyPerforma™ Single-Use Fermentor (S.U.F.)
The S.U.F. is engineered for optimal oxygen mass transfer, mixing, and temperature control, and performs comparably to traditional stainless steel systems. Using traditional, fundamental engineering principles, scale-up and process development work is streamlined – offering you cost savings and efficiency.
Foresight™ Prepacked Plates And Columns
Foresight filter plates and columns are prepacked with a range of Bio-Rad process chromatography media, offering process scientists convenience and reliability for their high-throughput experimentation needs.
LifeASSURE™ PFS series PTFE filters offer the ultimate in microorganism retention for air and gas streams while providing superior air flow capacity.
Inline Conditioning For Process Chromatography
GE Healthcare has delivered a wide range of IC systems for researchers and process engineers who need to formulate buffer solutions precisely at the time of use using stock solutions of the buffer components, providing a reproducible, fully automated IC process.
The formulation scientists at Cook Pharmica have great experience in a variety of formulations and product presentations. The development team will integrate the biophysical and biochemical characterization of your molecule with the final product format, developing a formulation that will ensure delivery of a stable product to the patient.
BIOPROCESS ONLINE VIDEOS
Biobanking And The Future Of Translational Medicine: Dr Gyorgy Marko-Varga Interview 2 Of 3 Dr Gyorgy Marko-Varga highlights how biobanking will be critical to realize the promise of Translational Medicine and what challenges we need to overcome quality hurdles going forward.
Advancing Translational Medicine: Dr Gyorgy Marko-Varga Interview 1 Of 3 Dr Gyorgy Marko-Varga talks about the future of Translational Medicine and the challenges in going from lab bench experiments to predicting dose in man.
The Future Of Translational Medicine: Dr. Gyorgy Marko-Varga Interview 3 Of 3 Speaking at The 2nd Sino-American Symposium on Clinical and Translational Medicine in Shanghai, China, in June 2011, Dr Gyorgy Marko-Varga highlights the challenges and opportunities of Translational Medicine and the effort to take data and knowledge gained in the lab to actually guiding drug selection and optimal dose.
BIO INDUSTRY NEWS
World Courier Management
World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.
Beckman Coulter Life Sciences
The integrated resources of Hach help you monitor compliance to pharmaceutical water and cleanroom facility standards. Our world-renowned instrumentation combined with our associates' expertise gives you the confidence to move towards parametric release and process peace of mind.
3M Purification, Inc.
3M Purification is a world leader in advanced depth filtration systems and membrane-based separations, offering a range of high performance and high quality products to meet a variety of processing challenges facing today's bioprocess industry.
ABOUT BIOPROCESS ONLINE
Bioprocess Online is the leading source of technical information and thought leadership for the biotherapeutic community. If you are a bioprocess engineer, scientist, bioprocessing manager, biotechnology producer, consultant, QA/QC, project manager, director, purchaser, marketer, or if you are involved in biopharm supply chain or facilities management, you now have access to a comprehensive Web community delivering the latest updates on the business and scientific information you need to succeed in your industry. From upstream to downstream processing through bioanalysis and biomanufacturing, our goal is to provide readers with the most up-to-date information about the issues, challenges, and news they care about most.
BioProcess Online is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
Please take a moment to join our community and discover the benefits of your free membership.
Attendees call it “an A+ show,” and Pharma EXPO 2015 will deliver solutions for the entire pharma supply chain from 200 top-tier suppliers, networking opportunities with 5,000 peers and a world-class conference program from International Society for Pharmaceutical Engineering (ISPE).
MVA applied to Raman Spectroscopy
This webinar will cover multivariate data analysis applied to Raman data.
Multivariate Statistical Process Control and Batch Monitoring
This webinar will cover the basic concepts in multivariate data analysis, with special emphasis on Process Control
World Courier Biomedical Seminar 2015
The World Courier Biomedical Seminar is the global conference where pharmaceutical, research and regulatory leaders receive insight on the dynamic industry — and the impact on global specialty transport. You’ll collaborate with industry thought leaders to surface new and innovative ways to solve business challenges.