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  • Laser Drilling Tablets for Use in Osmotic and Other Novel Drug Delivery Systems

    An overview of laser drilling, a technique used in medical device manufacturing, shows that it might offer benefits for use in combined drug-devices. It allows precise drilling of tiny holes into tablet surfaces at high throughput levels.

    Frank Gaebler, Coherent, and Graham Coffee, Control Micro Systems
  • RFID's Near its Tipping Point...

    Implementing track and trace technology is not some science project, but an imperative for the drug industry, writes Laura Osbursen, director of enterprise security for Unisys. However, the factors that have held it back may soon be disappearing.

    Laura Osburnsen Director, Enterprise Security, Unisys Global Commercial Industries
  • Detailed Study Shows ROI and Savings from RFID Implementation

    A study just released by the University of Texas (Austin) shows that pharma companies that implement RFID typically realize 900% ROI. The technology should save the industry and the healthcare sector $46 billion, the research suggests.

  • How to Project Leadership Qualities (Even When You're Scared Stiff): Speak Out and Speak Strong

    Is your career advancing as quickly as you'd like? If not, take a good, honest look at the way that you communicate. Are you projecting "leadership" qualities? This article presents tips that will make you appear self-assured and confident, even if you aren't. Wallflowers, take heart. Play the part of the confident leader often enough, the author suggests, and you'll become a leader, whatever your sphere of influence.

    John M. McKee
  • Pharmaceutical Industry Management and Careers | How to Project Leadership Qualities (Even When You’re Scared Stiff): Dress and Act the Part

    Leadership is conveyed not only by the way you express your opinions, but by such things as the way you dress and present yourself (and even the way your office is set up). Career coach John McKee offers five keys to "looking and acting" like a leader. With practice, he says, they'll transform you into a more confident person (and the change is likely to be noticed by those who can advance your career).

    John McKee
  • From the Editor: Into the Light

    Drug manufacturing can only advance if drugmakers, regulators, academics and vendors join forces to mine and interpret new data.

  • Tech Transfer: Don't Fumble the Hand Off

    Technology transfer was once taken for granted as something that would “get done anyway.” Now it’s an indicator of manufacturing excellence and a core competency for drug innovators.

    Angelo De Palma, Ph.D., Contributing Editor
  • Dissolution Testing in the 21st Century

    The Hot Topic session on dissolution testing at the recent AAPS Annual Meeting put PAT expert Ajaz Hussain on the hot seat in a debate over the applicability of a "testing tablet" to determining the stability of a solid dosage form.

    Bill Swichtenberg, Senior Editor
  • On-demand Data Access and Analytics Enable Decisions for Process Excellence

    Critical to any PAT effort is having a single point of easy, on-demand access to all relevant data, in a context that’s meaningful to diverse groups of users. But data must be presented in a way that facilitates the identification and understanding of cause-and-effect relationships. Justin Neway, CSO and EVP of Aegis Analytics, talks about the issues and what they mean for PAT-related IT.

    Justin O. Neway, Ph.D., EVP and Chief Science Officer, Aegis Analytical Corp.
  • [The Problem with] Not Having a Personal Life Plan

    A business consultant and professional motivator, John McKee asserts that women face significant obstacles to professional growth and urges men in management to help women surmount those obstacles. In this excerpt from his book, "21 Ways Women in Management Shoot Themselves in the Foot," McKee discusses the reasons for and benefits of outlining a life plan.

    John M. McKee, and Four Windows - No Walls Consulting, LLC
  • PAT in Perspective: Safe? Yes. Effective? Not So Much.

    PAT expert Emil Ciurczak points out that a repository of methods and standard practices, terms, units, etc. is critical to understanding (and thus controlling) the process of producing good, predictable, and reproducible solid dosage forms.

    Emil W. Ciurczak, Cadrai Technology Group
  • A Closer Look at Form-Fill-Seal Technology

    Cost efficiencies are driving increased use of FFS in liquid parenteral drug packaging, but attention to process parameters, testing and validation is critical

    Rakesh P. Patel, Gayatri C. Patel, Nikunjana A. Patel, Dr. Madhabhai M. Patel and Rishad Jivani, S.K. Patel College of Pharmaceutical Education and Research, Ganpat University, Gujarat, India
  • Macher and Nickerson on Benchmarking Pharma and FDA

    Georgetown Professor Jeffrey Macher and Washington University Professor Jackson Nickerson discuss their extensive benchmarking project, which analyzed FDA regulation, in particular cGMP inspections, as well as industry manufacturing performance.

    Agnes Shanley, Editor in Chief
  • Analyze This!

    The 450-page Pharmaceutical Manufacturing benchmarking study released in October offers a gold mine of information on how to improve, for those industry professionals and regulators brave enough to dive into the data. In this feature, Jeff Macher and Jackson Nickerson discuss challenges they faced, study results, a major caveat and future plans.

    Agnes Shanley, Editor in Chief
  • Talecris Makes Manufacturing Professionals Industry Ambassadors

    GSK has sent its sales reps out to improve the industry's image, but last August, Talecris Biotherapeutics allowed its manufacturing and development staff to become industry spokespeople. Could this be the wave of the future for pharma?

    Agnes Shanley, Editor in Chief
  • Ten Steps to Process Improvement, Part 1

    Six Sigma can, and should, become a way of life for mid-level manufacturing executives, directors and managers.

    Ronald D. Snee, Ph.D., Principal, Tunnell Consulting, Inc.
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