FROM THE EDITOR
The Cold Chain Global Forum has grown from a niche conference to the life science industry's leading temperature-controlled event.
PHARMA MANUFACTURING INSIGHTS
Cardinal Health Searches For A Sensible, Sustainable Pharma Packaging Solution
In 1971, Cardinal Health had its grassroots start as a small distribution company in Columbus, Ohio. By 2012, it had grown to be a Fortune 100 company, an industry leader in improving the cost-effectiveness of health care and a pioneer in the compliant handling of temperature-sensitive products. Still, by the end of 2012, Cardinal Health had yet to achieve a completely practical, sustainable packaging solution for its mixed loads of cold chain and ambient-temperature bulk shipments. This was about to change as the result of the momentum created by three earlier accomplishments.
Balancing Speed-to-Market With A Risk-based Approach To Compliance
Addressing compliance pressures can drastically affect productivity and manufacturing cycles, so a risk-based approach to compliance can help biopharmaceutical companies balance the scales. When not everyone in the industry can be “first-to-market,” it’s important to glean information from being the “first-to-fail.”
Manufacturing Spray-Dried Dispersions: Process Control Strategies
A significant share of current drug development pipelines include active pharmaceutical ingredients (APIs) that fall into BCS (biopharmaceutical classification system) 2 and 4 spaces. These compounds are typically characterized by their lowaqueous solubility and thus poor bioavailability, requiring advanced formulation approaches. Various approaches have been developed to enable these types of compounds, including particle size reduction (eg, micronization), chemical modification (eg, salt forms and pro-drugs), complexing agents, solubilized liquid forms (eg, SEDDS), and solid amorphous dispersions.
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.
The Versatility Of Charged Aerosol Detection
Charged Aerosol Detection (CAD) applies to a broad range of HPLC separations and possesses a number of desirable characteristics for detection and quantitation of various compounds including those without UV absorbing chromophores.
PHARMA CONTRIBUTING EDITORS
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?
Making The Switch To Single-Use: Have You Thought Of Everything?
In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.
Is Sustainability Possible With Single-Use Technology?
At this point, it is well known that single-use technology (SUT) can offer many benefits to a manufacturer and their facility. However, there are concerns that single-use technology produces too much harmful waste to achieve sustainability. But is this true?
Could Birth Of “Big Generic” Be Foreshadowing “Big Biosimilar?”
The past few weeks, the generics market has seen several players jump ship and one company grow significantly — and to some, alarmingly — larger.
TPP Negotiations Stall, Hold Back Biosimilars Market
As if the biosimilar naming debate between brand-name pharmaceutical companies and generic drugmakers wasn’t enough, these two sides continue to challenge each other — this time, over biologics data exclusivity in the ongoing Trans-Pacific Partnership (TPP) negotiations.
PHARMACEUTICAL ONLINE VIDEOS
AcuTemp Company Overview Video
The mission of AcuTemp Thermal Systems began taking shape over 25 years ago when Keith and Chris Meyer were working in a third-world country.
Video: Q&A With Fred Hassan, Former CEO Of Schering-Plough With the recent announcement of the Merck & Co acquisition of Schering & Plough, Fred Hassan the former Chief Executive Officer has been speaking to Meettheboss.TV on the future of the pharmaceutical Industry, mergers, acquisitions and the resistance felt.
Firecrest - DIA 2010 Alan Horgan, CEO of Firecrest, attends DIA 2010 to present their innovative suite of web-based products and services conceived to definitively enhance site performance by improving the compliance, consistency, and execution of all study-related activities, at all sites, and by all study personnel.
Flexible & Fully Enclosed Syringe Filling System Video
Check out this unsurpassed syringe filling line that's completely flexible to support small and large batches, can be manual or automated, and is fully enclosed in a barrier isolator.
Cold Chain Technologies Introduces The KoolTemp® GTS Evolution 1400 Liter Pallet Shipping System
Thermal packaging thought leader introduces successor to flagship pallet solution
Sartorius Intec is a globally operating premium provider of industrial weighing and control equipment. Our product solutions are used throughout the entire manufacturing process for products, ranging from incoming goods inspection to production, to final quality control and logistics. Sartorius Intec high-quality measurement and inspection equipment, such as high-capacity load cells, checkweighers, metal detectors and industrial scales. Among our division’s major customers are, in particular, the food, chemical and pharmaceutical sectors and the basic industry. Especially in the sector of process tank and hopper weighing, our company ranks among the world's leading suppliers.
Micromeritics Instrument Corporation
Micromeritics manufactures a broad line of automated analytical laboratory instruments that measure the physical characteristics of powders and solids for fundamental research, product development, quality assurance and control, production, and process control applications.
We believe in a world where all medicines are safe for patients
Today there are many variables, complexities and risks in the pharmaceutical supply chain. One thing in our control is temperature. With the right comprehensive data monitoring system to measure critical parameters that can affect the safety and efficacy of medicines, most often temperature, pharmaceutical manufacturers can assure patients with hard evidence their medicines have been safely handled throughout their lifecycle. ELPRO helps customers do just this.
Weiler Engineering, Inc.
Weiler Engineering is America's leading provider of aseptic Blow/Fill/Seal liquid packaging machines for pharmaceutical and healthcare applications
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PHARMA EXPO 2015
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).
10.01.15 -- Integrated Traceablity To Combat Drug Counterfeiting
10/01/15 Pharmaceutical Online Newsletter
09.30.15 -- The Evolution Of A Cold Chain Conference
09.30.15 -- The Evolution Of A Cold Chain Conference
09.29.15 -- Performance-Based Pricing Poised To Hit Pharma
09/29/15 Pharmaceutical Online Newsletter