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The Lead

Triple Threat

September 24, 2014 | 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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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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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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CMOs Most Critical to Success Factors

April 30, 2014 8:38 am | by Eric Langer, President and Managing Partner, BioPlan Associates | Comments

Outsourcing continues to be an integral part of biopharmaceutical manufacturing, and facilities are outsourcing activities today at heightened levels. As a result, the contract manufacturing organization (CMO) community has seen an expansion of opportunities, leading to increased competition.  In this science and technology-driven environment, how can CMOs separate themselves from the pack?

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Entrepreneurial Spirit

April 22, 2014 3:19 pm | by Mike Auerbach, Editor in Chief | Comments

PCI, Inc. a contract manufacturing and research organization based in Newburyport, MA that develops and manufactures NCEs, generic APIs and fine chemicals has grown from a small start-up to a company that can now take a product all the way from development to commercial production in a smooth and seamless process for its clients.

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Tablet Coating Musts

April 16, 2014 9:21 am | by Mike Tousey, Techceuticals | Comments

When it comes to coating tablets there are musts that really count and then there are the other things.                         

The Elephant in the Lab Room - The Path to Resolving Storage Space Issues

April 2, 2014 8:28 am | by Deborah Suzan Huff, AIA, NCARB, LEED AP BD+C, SSOE Group | Comments

It seems simple enough . . . when planning a new laboratory facility, ensure that there is adequate storage space and that it is located in the right place and arranged to accommodate access based upon frequency of use. And yet, much can go wrong…and often does.

Mitigating Supply Chain and Production Challenges in Biomanufacturing

April 1, 2014 3:07 pm | by Nancy N. Berg, President and CEO, ISPE | Comments

Today’s biopharmaceutical manufacturers face a wide range of challenges. The regulatory landscape has become more scrutinizing as it has grown increasingly complex. Supply chains have grown into supply webs, with intricate logistics and compliance issues. Competition — and pressure to cut costs — keeps climbing along with the rate of mergers and acquisitions.

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Success Through Sterilization - Considerations for Building a Clean Room Facility

March 28, 2014 8:30 am | by Julie Ackerman, sr. director, Communications and Public Relations, PMMI — The Association for Packaging and Processing Technologies | Comments

When developing a clean room program, it is important to make sure that the plan meets all regulatory requirements mandated by agencies such as the Institute of Environmental Sciences and Technology (IEST) and the International Organization for Standardization (ISO).

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Flexible Packaging - Growth and Flexibility Make Reed-Lane a Valuable Packaging Partner

March 27, 2014 9:07 am | by Mike Auerbach, Editor-in Chief | Comments

No two packaging projects are alike and in order to make it all work and to keep everything on track and everyone happy you need to have a flexible, responsive and quality-driven organizations. Reed-Lane has deftly combined these qualities along with recent investments to create a truly flexible contract packaging operation.

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Pharmaceutical Controls with Zero Contamination Transfer

March 14, 2014 11:39 am | by Douglas McPheters, President of HoloTouch, Inc. | Comments

How important are intuitive, durable and clean controls for equipment used in your business? As a practical matter, controls that require operators to actually touch them, wearing gloves or not, can never be really clean, however many protocols or chemicals are employed.

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High-Performance Exosome Purification and Characterization via Density Gradient Ultracentrifugation and Dynamic Light Scattering

March 12, 2014 2:06 pm | Comments

Exosomes purification and analyses comprise a fast evolving research area; more than 70% of published research on exosomes has been done within the last six years. Challenges to researchers working with exosomes include setting up density gradients by hand, because it is tedious, time-consuming and subject to user, lab, and method variability.

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