Our annual reader survey looks at issues facing innovator companies and the CMO/CSOs that support them.
Operational Excellence has often been ambiguously defined: “excellence in everything we do,” “...
In the past year, cGMPs have become the focus of considerable attention in the legal community. In...
It is recognized that any medical device that punctures the skin or any medication that enters the bloodstream must be sterile, and sterilization procedures are reasonably well-established in the pharmaceutical and medical device industries. What may not be as well understood is that devices and medications should also be essentially free of particles (i.e. clean).
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.
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.
Catalent's clinical-stage biologics facility is a critical part of the company's global capabilities.
Protecting the efficacy of pharmaceutical products through packaging solutions typically requires a combination of active agents and passive barriers. Packaging experts have turned to various types of protective packaging to safeguard drug products against degradation, which can lead to loss of stability, shortened shelf life or an ineffective drug delivery.
Since 2008, glass delamination has been the subject of recalls for a variety of drug products. Manufacturers of pharmaceuticals and glass containers have joined together to identify risks for delamination and have developed strategies that could reduce occurrences.
The modern definition of Process Validation has abandoned the concept of a one-off activity where success consists of obtaining three commercial batches of product. Instead, the new guidance describes Process Validation as a continuous lifecycle founded upon the principles of scientific understanding, and divides it into three stages.
Tools to Stop Drug Counterfeiting: Track and trace is a simple and effective way to deter counterfeitersAugust 29, 2013 12:10 pm | by Michael Lucas, CEO of Frequentz | Comments
In response to the significant threat counterfeits have to patient's safety, health officials and manufacturers have sought to mandate track and trace and serialization as part of global regulations and guidelines. For example, EU Serialization will be introduced in 2014, followed by the FDA/California Serialization standard in 2015 and further down the road a federal mandate.
High Shear Granulating: A look at advances in wet milling and controlled spraying in granulation operationsAugust 29, 2013 11:03 am | by Raja Krishnan and Michael Buzecky, Fluid Air, Inc. | Comments
High shear wet granulation is a cornerstone of the formulator’s and process engineer’s pharmaceutical manufacturing toolbox. It is used to increase the density and particle size of a composition to improve powder flow and compressibility on the tablet press when dry processing methods are insufficient to produce tablets or capsules with acceptable uniformity, hardness, and friability.
The biopharmaceutical manufacturing industry today is enjoying a rebound in budgets, as the global financial crisis continues to recede. Despite positive signs, lessons learned from the economic crunch remain fresh, and continue to drive demand for cost-cutting and productivity.
New Hampshire-based LSNE offers right-sized fill/finish and lyophilization services that are tailored to client's needs and production requirements.
It is no secret that the transition to single-use technology for biopharmaceutical applications is often disruptive. Yet, as the industry continues to see the proven benefits of integrating these technologies, and in some cases fully transitioning to them, the paradigm shift that happened in the upstream is making its way into the downstream.
Employing single-use technology and automation to improve productivity and cost of goods.
Pharmaceutical Processing spoke with David Downey, Almac's Vice-President of Commercial Operations to get his views on packaging trends in general and some of the issues facing contract packagers.
Counterfeit drug rings operate across borders and rake in billions of dollars every year. This is costing legitimate drug makers a small fortune in lost sales, all the while putting patients at risk of unknowingly taking counterfeit drugs. Experts estimate hundreds of thousands of people around the world die because of counterfeit medicines each year.