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Packaging Entrepreneurs: Legacy Pharmaceutical Packaging

February 20, 2015 | by Mike Auerbach, Editor-In-Chief | Comments

Legacy Pharmaceutical Packaging, in St. Louis, Missouri is proud of its entrepreneurial spirit, its operational flexibility and technological expertise, and the breadth of packaging services it offers to its customers in a wide variety of segments of the healthcare industry.

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Surviving Pharma’s Uncertain Future

November 20, 2014 10:08 am | by Nathan Furr and Jeff Dyer | Comments

The average cost of developing an approved therapy is around $4.3 billion dollars for companies with three or more approved therapies, according to an analysis completed by Forbes. Imagine, then, our surprise when we discovered a biotechnology company outside of New York City that had developed three approved therapies for an average cost of $0.7 billion dollars – less than 20 percent of the industry average.

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Cleanroom Alternatives

November 13, 2014 2:39 pm | by Deepak Mistry and Steven Lynum, Panasonic Healthcare Corporation of North America | Comments

Clean rooms are the standard for cGMP-compliant manufacturing, but the significant time and high costs of manufacturing and maintenance, as well as the lack of mobility, makes them difficult to justify.        

Desiccant Canisters

November 13, 2014 11:37 am | 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.                 

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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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Ensuring Dedusting Efficiency by Design

October 31, 2014 3:03 pm | by Nic Michel, General Manager, North America, Pharma Technology Inc. | Comments

Dust has always been an unwanted byproduct of tablet manufacturing. In a perfect world, all powder would flawlessly flow into the hopper, and 100% of the product would emerge as finished tablets. In practice, though, most tablet presses are so inundated with dust after an eight-hour run that they form miniature snow piles on both sides of the feeder, and build-ups of material occur around the takeoff bar and recirculation channel.

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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