Articles By Trisha Gladd

41. Merck Champions Single-Use By Addressing Emotion Vs. Science 3/2/2015

    Lowering the cost of medication is the key to the US gaining a stronghold on the global pharmaceutical market. As anyone knows, in order to lower the cost of medication, the cost of manufacturing will need to be lowered as well. According to Chris Smalley, Ph.D., director of validation compliance at Merck, single-use technology (SUT) could be the hero. 

42. Merck Uses Automation And Disposables To Drive Upstream Process Development 1/21/2015

    Automation and disposable technology have offered considerable efficiency improvements to speed cell line development; however, a major challenge with process development for biologics is how labor intensive it can become.  Many different interactions and parameters can impact product quality and product titer, which typically requires iterative rounds of statistical experimentation using up to 20 reactors or more per study. For cell culture mAb processes, this development work can take three to four months to complete, which adds considerable cost for a company in multiple ways. Because of this challenge, Dr. David Pollard, executive director of BioProcess Technology & Expression, BioProcess Development at Merck, and his dedicated technology group wanted to see how the benefits of automation and disposable technologies could be translated into tools to drive high throughput upstream process developmen

43. Bayer Change Notification Process For Raw Material Supply Encourages Supplier Collaboration And Transparency 12/15/2014

    When it comes to raw material supply, increased regulatory focus on the raw material supply chain is creating a transformational change in the industry. Because of this, quality agreements create a responsibility among suppliers to notify their partners with advanced notice any time a change is made to the raw materials those partners are receiving. To ensure change notifications are handled properly and evaluated thoroughly, Bayer Healthcare utilizes an internal process that allows notifications to be filtered to the appropriate stakeholder and reviewed thoroughly before action is taken. Albert Obrero, Jr., Senior Project Specialist at Bayer HealthCare, recently presented the Bayer process to an audience at Bioprocess International 2014, where he outlined how it works as well as its benefits.

44. Supply Chain Management Of Temperature-Sensitive Products At Novartis: Advice From An Expert 9/11/2014

    Gone are the days when pharma can depend on blockbuster drugs to carry them to financial heights; instead, successful pharmaceutical companies are taking a different approach and looking to demand to determine their next step in drug development and supply chain management. For Novartis’ Michael Trocchia, this demand has resulted in a new role as the Global Supply Chain Lead for Cell Therapy Products. In this article, he discusses the challenges associated with managing the supply chain for a temperature-sensitive product and what best practices he applies in order to contribute to Novartis’ ability to maintain a top spot in big pharma.

45. BPI Offers A Look Into QbD At Genentech 8/19/2014

    Brian Horvath, Scientist and Technical Development Team Leader, Late Stage Cell Culture at Genentech, says the company’s QbD approach has been evolving over the past several years. It is used in a number of ways in the bioprocess areas—cell culture, purification, and formulation—which allows validation that the process as a whole reliably produces product with the desired critical quality attributes. In October, Horvath, will present a case study at the BioProcess International Conference and Exhibition outlining how QbD was used at Genentech during the characterization of a CHO-based monoclonal antibody.

46. An Exciting Change On The Horizon 8/12/2014

    In September, Bioresearch Online will become BioProcess Online. The transformation of our brand is intended to address our evolution as a media outlet and illustrate our editorial mission more clearly.

47. FDA's First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn't 6/23/2014

    On June 10^th, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren’t getting before. Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang with KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.

48. FDA Approval Pushes Novartis Into 21st Century Vaccine Development 6/18/2014

    In 2009, the world experienced a global threat in the form of H1N1. Despite a prompt response to the need for a vaccine in the United States, it was still not available until six months later and not enough doses were even produced to cover all Americans. During the year-long battle with the deadly virus, the CDC estimates between 8,870 and 18,300 people died due to H1N1-related complications. In the world of influenza vaccine production using chicken eggs, the response experienced during the H1N1 outbreak is not uncommon. Is this the best our industry can do? Novartis says NO.

49. Where Do Ideas Come From? How To Transform An Idea Into A Product 5/30/2014

    Shabbir Dahod, president and CEO of TraceLink, has been working in the pharmaceutical industry for over 11 years, and in the last 30 years, has founded three companies prior to launching Tracelink. When asked how he comes up with the ideas that have brought him so much success, Dahod credits a very specific approach he learned about during the commencement speech at his wife’s college graduation. The speaker was the president of John Hancock at that time, and Dahod says he made a comment that sticks with him to this day. “He said what you need to do is look for connections and patterns from one segment to another,” says Dahod. “What it forces you to do is think a little bit more about what’s happening at the meta level. How could that pattern be applied somewhere else?”

50. AstraZeneca's Focus On Supply Chain: With Change Comes The Obligation To Respond 5/20/2014

    In the pharmaceutical industry, we have seen a number of changes over the last few years that have altered how companies operate and interact. To understand the impact of this trend and learn how some of the industry’s biggest names are adjusting to the transformation, I recently spoke to supply chain experts from AstraZeneca, GSK, Novartis, and Valeant Pharmaceuticals to find out what they’re doing to successfully ride this wave of change into the future. The first of these conversations was with Mark Holder, executive director, North American regional supply chain at AstraZeneca, who talked about how this strategic reconfiguration has required AstraZeneca to leverage their infrastructure and integrate it in a key way that saves money.