Articles
The Lead
Under The Almac Umbrella: Almac replicates its success in Ireland with a full range of services in the United States
April 19, 2013 | by Mike Auerbach, Editor in Chief | Comments
Almac, a CMO with headquarters in Ireland and a growing presence in the United States, can help alleviate many of the stresses and concerns inherent in pharmaceutical manufacturing with a range of services that encompasses everything a sponsor might need to get a drug to market as quickly and efficiently as possible.
Pharmaceutical Serialization and Implementation Myths
April 11, 2013 3:23 pm | by Chris Siegele, Serialization Specialist, Omega Design Corporation | Comments
Take a hard look at the...
Make Your Mark
April 11, 2013 10:17 am | by Jonnatha Mayberry, Associate Editor | Comments
In the pharmaceutical industry, while aesthetics are a consideration, one of packaging’s most...
Encapsulating Service
April 10, 2013 3:58 pm | by Jonnatha Mayberry, Associate Editor | Comments
Capsules are an important solid...
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Defining Flexible Facilities: When is a flexible facility being flexible?
April 19, 2013 10:28 am | by Maik W. Jornitz, COO, G-CON Manufacturing LLC | CommentsWhat does a flexible facility really mean? Flexibility of facilities is often related to two major factors; multi-product processing and scalability. Other factors are mobility and achievable product-lifecycles. Processing flexibility is often used in conjunction with single-use equipment technologies. These unit operations have a multitude of technology and economical benefits.
Top of the Pops: Single-use/disposable technologies gain in popularity and make their way up the charts
April 18, 2013 11:40 am | by Mike Auerbach, Editor in Chief | CommentsIf you were to liken the interest in single-use and disposable technologies in the pharmaceutical industry to terms we are familiar with when talking about hot web topics, you might say they have been “trending” for several years, or perhaps they have gone “viral” – but that might have some negative connotations in the industry, after all the industry is trying to eliminate viruses not promote them.
Lost in Translation? - Can QbD Translate to Jobs in the Pharmaceutical Industry?
April 17, 2013 10:24 am | by Girish Malhotra, PE, EPCOT International | CommentsIn recent news we have read that some of the major pharmaceutical companies are getting out of, or realigning their API manufacturing. This can mean that we are going to loose additional jobs. In the last few years about 150,000 jobs have been lost. Pharmaceutical companies have been increasingly acquiring their API needs from the developing countries.
Status Update: QbD
April 16, 2013 11:34 am | by Ronald D, Snee, PhD, Snee Associates, LLC | CommentsThe US Food and Drug Administration (FDA) introduced the idea of Quality by Design (QbD) in 2004 as part of the Process Analytical Technology Guidance. The purpose was to design quality into the product and process rather than try to test quality into the product at the end on the production line. It has been known for a long time that “quality by testing” is a low-yield and costly strategy.
Outsourcing of Fill-Finish Operations Continues
April 15, 2013 9:38 am | by Eric Langer, President and Managing Partner, BioPlan Associates, Inc. | CommentsFill-finish operations continue to be one of the most heavily outsourced activities in the biopharmaceutical manufacturing market today. This traditional field for outsourcing is something of a paradox. On one hand, this is a relatively low value-added operation; on the other hand, it deals with the finished product in its most valuable state, where the risks of a contamination event or other failure are at their highest.
QbD for Tablet Development - Saving Time and Money with Small Scale Formulation Development
April 12, 2013 11:25 am | by Michael Gamlen, Gamlen Tableting Ltd, Biocity Nottingham, UK | CommentsUnder the Quality by Deign (QbD) paradigm, new pharma product must be correctly designed to take into account the disease and its impact on the patient; the patient population; the drug properties; the preferred route of administration (from a clinical and a marketing perspective); and the requirements of the organization manufacturing the product.
Change is Good - Olympus Biotech's Diverse Past Has Prepared it for the Future
April 12, 2013 10:52 am | by Mike Auerbach, Editor in Chief | CommentsOlympus Biotech, a biopharmaceutical contract manufacturing organization (CMO) based in Lebanon, NH has seen plenty of change over its history and has emerged as a company with the expertise, experience, technologies and facilities to handle the inevitable changes the industry has in store.
Transparency in the Supply Chain
April 10, 2013 1:29 pm | by Mike Rozembajgier | CommentsAn increase in the number of Internet pharmacies distributing pharmaceuticals to consumers online and heightened public scrutiny have led authorities to pay close attention to the issue of counterfeit medications. And already this year, the U.S. Food and Drug Administration (FDA) has issued a health care provider alert warning about an unapproved, counterfeit cancer medication that was distributed in the U.S.
Disposable Chromatography Technologies
April 4, 2013 8:36 am | by A. Mark Trotter, Marketing Manager, 3M Purifications Inc. | CommentsThe acceptance and use of single-use disposable devices and accessories has been a well established technology in the biopharmaceutical industry. Early adoption of filter capsules and plastic tubing grew in complexity and scale from the early 1980s through the 2000s till today with a broad scope of single-use product offerings expanding into downstream processes.
Automating with Regulators & Controllers
March 8, 2013 8:23 am | by Jonnatha Mayberry, Associate Editor | CommentsAutomation is not always necessary in manufacturing facilities, but at times it is highly beneficial. For pharmaceutical and biopharmaceutical manufacturing facilities in search of precise, controlled process lines, implementing automation is a no-brainer way to achieve stability.
Equipping the Front Lines of Quality Control
March 1, 2013 8:26 am | by Mike Auerbach, Editor in Chief | CommentsIn every industry, producing quality products remains the absolute top priority. In the pharmaceutical industry – this is no different – and with the added onus of lives being at stake – the impetus to deliver quality products is even more pressing.
CDMO Cedarburg Hauser Pharmaceuticals Carves Its Niche in the Changing API Market.
February 27, 2013 8:25 am | by Jonnatha Mayberry, Associate Editor | CommentsIn the structure of a successful drug, active pharmaceutical ingredients (APIs) serve as the medicine’s foundation. When outsourcing API development, pharmaceutical companies look for a service provider that can deliver a combination of expertise, technique, and flexibility.
Emerging Fourth Generation Barrier Technologies
February 22, 2013 8:21 am | by By Sterling Kline, RA IPS | CommentsBy 2013 barrier technology has become overwhelmingly accepted as the basis for new aseptic processing facilities. The traditional clean room facilities of the 20th century are being rapidly replaced with advanced barrier based technology filling facilities. This technological evolution is dramatically reducing the risk of product contamination and risk of infection to patients.
Narrowing the Costs of Outsourced Labor Between the U.S., China & India
February 15, 2013 10:08 am | by Edward S. Price, President, PCI Synthesis | CommentsNearly a decade after New York Times columnist Thomas Friedman declared the business “World is Flat,” we’re seeing some interesting changes that have less to do with technology. These changes have more to do with local economics. Countries like India and China had the advantage of having a workforce of engineers and chemists available to work at a fraction of what their U.S.-based counterparts received.
Re-Engineered Central Dust Collection System Delivers Cost, Safety Benefits
February 11, 2013 4:00 pm | CommentsThe safe removal of residual dust is a critical element when processing solids. It’s also needed throughout production, from active ingredient handling through packaging and shipment of finished product. A central dust collection system removes particulate, increases safety, and reduces maintenance costs.
