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The Lead

Desiccant Canisters

November 13, 2014 | by Mark Florez, Product Manager, Clariant Healthcare Packaging; Randy Caspersen, Vice President, Sales and Marketing, Omega Design Incorporated | Comments

As global demand for bottle-packaged pharmaceuticals grows, incremental upgrades in desiccant canister design yield substantial performance improvements.                 

Cleanroom Energy Efficiency Opportunities

November 6, 2014 2:37 pm | by Al Fosco, Frigel North America | Comments

Like so many industries, pharmaceutical processing is increasingly focused on improving the operational energy efficiency. One challenge that often stands in the way: cleanrooms. In these facilities, energy efficiency understandably takes a back seat to the mission of clean production. As a result, due to FDA-required filtration, high-performance processing machines and other factors, cleanrooms are energy intensive.

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The Biosimilars Market

October 31, 2014 11:19 am | by Sarfaraz K. Niazi, Ph.D., Founding Chairman and CEO, Therapeutic Proteins International | Comments

Biosimilars have increasingly become an important and somewhat controversial topic in the healthcare space. Depending on who one speaks to, the opinion on biosimilars changes. However, there are certain truths that all stakeholders should keep in mind.

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High Potency, High Reward

October 31, 2014 10:43 am | by Nikita Ernst, Associate Editor | Comments

SAFC, a global supplier of a a wide range of services to the biopharm and pharmaceutical industry, has recently expanded their Madison, Wisconsin facilities to neighboring Verona to rev up their high-potency API manufacturing capabilities.

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A Roadmap for Risky Territory

October 15, 2014 3:49 pm | by Jamie T. Hintlian and Ryan Kelly; Ernst & Young | Comments

When it comes to the supply chain, business can be risky. A seminal survey of companies in various industries spanning 62 countries found 85% of respondents have experienced a supply chain disruption over the last 12 months, and 50% of companies had more than one disruption.

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Challenges of Scale-up and Commercialization

October 2, 2014 8:25 am | by Christopher Kulp, Executive Vice President, Richman Chemical | Comments

The development of new chemistry-based products for life science markets requires the expertise of talented researchers. However, these same researchers are typically not prepared to solve the many other critical problems necessary for successful commercialization.

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Triple Threat

September 24, 2014 2:02 pm | by Mike Auerbach, Editor In Chief | Comments

Capsugel acquires Bend Research and Encap Drug Delivery to create a comprehensive solid dosage form solutions group.                       

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A Tale of Two Cities - SAFC's Irvine, Scotland and Lenexa, KS Dry Powder Media Facilities

September 11, 2014 1:38 pm | by Mike Auerbach, Editor In Chief | Comments

SAFC, a global company that supplies a multitude of services to the biopharm/pharmaceutical industry has recently opened a new Dry Powder Media (DPM ) manufacturing facility in Irvine, Scotland to complement their Lenexa, KS DPM facility. By doing so SAFC has shown their commitment to their customers and this growing segment of the pharmaceutical industry.

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Trends in High Tox Manufacturing

August 26, 2014 2:12 pm | by Mark Butler, Vince Cebular, Sam Halaby, George Petroka, Thomas Woody; Integrated Project Services, Inc. | Comments

Due to the special containment requirements for manufacturing highly potent active pharmaceutical ingredients and cytotoxic drugs, we have seen many CMO’s invest in building additional capacity in this area. While there are tremendous benefits and a strong promise with these types of products there are also considerable challenges and risks associated with their production, especially in a multiproduct CMO environment.

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Processes for the Inspection of Cleaned Equipment in the Pharmaceutical Industry to Evolve

July 25, 2014 9:06 am | by The ISPE Cleaning Process Development and Validation Guide Task Team | Comments

When it comes to the inspection of cleaned equipment of pharmaceutical manufacturing equipment, there are currently no industry-mandated standards. Instead, various companies have had their own internal procedures for inspecting cleaned equipment, with visual inspection widely used as the primary method.

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The State Of Track & Trace Technology: Is The Industry Ready?

July 15, 2014 1:03 pm | by Kelly Ng, Product Manager, Healthcare, Epson America | Comments

As serialization becomes an ever more important part of the pharmaceutical industry and the FDA's track & trace deadlines loom in the distance, we sat down with Kelly Ng, the Healthcare division's Product Manage at Epson, to talk about the state of track and trace/serialization technology, whether the industry is ready for the new requirements and how companies can make sure that they will make the upcoming deadlines. 

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Getting Very Personal: The PCT Story

July 8, 2014 2:35 pm | by Mike Auerbach, Editor In Chief | Comments

Mention the terms ‘cell therapy’ or ‘regenerative medicine’ and many in the general public are still confused as to what those terms actually mean. But those in the know understand that cell therapy is a growing and thriving industry, with great potential to change the face of modern healthcare.

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What We Learned From Global CEOs: Pharma & Life Sciences Insights From PwC’s Global CEO Survey

June 18, 2014 9:41 am | by Nicholas J. Bonny and Rafael Lander, PwC Health Industries, Pharmaceuticals and Life Sciences sector | Comments

During the last quarter of 2013, PwC surveyed more than 1,300 business leaders across 68 countries around the world, and the pharmaceutical and life sciences sector was well represented. The results showed a number of positives for all businesses, notably a leap in CEOs’ confidence in the global economy. But PLS leaders are cautious as to whether this will translate into better prospects for their own companies.

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Numerical Simulations for Tableting and Coating

May 20, 2014 3:32 pm | by Sabine Goodwin, Senior Engineer, Technical Marketing; Dr. Oleh Baran, Application Specialist; Dr. Kristian Debus, Director, Life Sciences; CD-adapco | Comments

Facing unprecedented economic pressures, pharmaceutical manufacturing companies are continuously looking to improve on the quality of their products and the productivity of their processes. Multi-physics numerical simulation is emerging as game-changing technology to help step up efficiency, enhance quality, and shorten time-to-market through virtual prototyping and optimization.

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QbD in Test Method Development & Validation

May 13, 2014 3:38 pm | by Ronald D. Snee, PhD, Snee Associates, LLC | Comments

A characteristic of good science is good data. Quality data are arguably more important today than ever before. Data are used to develop products and processes, control manufacturing processes and improve products and processes. Quality data also reduces the risk of poor process performance and defective pharmaceuticals reaching patients.

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Balancing Demand with Supply: Thermoplastic Elastomers Help Satisfy Growing Global Need for Pharma Packaging and Devices

May 6, 2014 3:38 pm | by John Voyce, PolyOne GLS Thermoplastic Elastomers | Comments

Many companies are looking for new ways to build faster throughput and greater scalability into their supply chains while optimizing costs. One proven approach is replacing traditional vulcanized rubber materials with thermoplastic elastomers (TPEs).

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