ARTICLES BY TRISHA GLADD
USP General Chapter <1207> Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing
In September, the US Pharmacopoeia released a proposed revision to USP General Chapter <1207> Sterile Product Package – Integrity Evaluation for public comment, which focuses on package integrity testing. This chapter is not mandated but does reflect recommended best practices. These changes are necessary to better protect not just the product but also the patient.
Getting Particular About Particulates: How Can You Avoid Becoming The Next Recall?
While there is much speculation about why there has been such an increase in FDA recalls due to the presence of particulate matter in injectables—aging equipment, cleaning deficiencies, discrepancies between regulators, and the list goes on—what companies need to worry about most is how to protect their product and the patient by avoiding this issue altogether. But how?
Tools for the Design of Vaccines to Help Reduce Clinical Failure
If you are involved in the pharma industry, then you are interested in saving lives. In the area of preventative medicine, therapeutic vaccines have proven to have a tremendous impact on the ability to save millions of lives. Similar to pharmaceuticals, vaccine development can take over 10 years and less than 10 percent of candidates reach commercialization. Reducing the cost of failure and increasing the chances of clinical success for vaccines is beneficial to both the pharma industry and those being treated for or protected from disease.
Supply Chain Management Of Temperature-Sensitive Products At Novartis: Advice From An Expert
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.
GSK Discusses The Transformation Of Biopharmaceutical Manufacturing: Single Use Is Only Part Of The Strategy
Historically, biopharmaceutical manufacturing has always been slow, expensive, and inflexible. However, the pressures in today’s biopharma space are driving trends in the opposite direction, which is causing experts to look for ways to drive costs down while improving flexibility and efficiency. GSK’s Randy Maddux, VP and Site Director of the company’s Global Manufacturing and Supply (GMS) site in Rockville, believes there are many factors involved in transforming biopharmaceutical manufacturing. And while single-use technology plays a key role, there are plenty of other aspects to consider.
BPI Offers A Look Into QbD At Genentech
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.
An Exciting Change On The Horizon
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.
How To Prepare A Facility For The Biopharmaceutical Revolution
Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?
Analytical QbD at Teva: Knowledge Is Power Only When You Share It
Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.
FDA’s First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn’t
On June 10th, 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.