ARTICLES BY TRISHA GLADD
Merck Champions Single-Use By Addressing Emotion Vs. Science
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.
Cell Thawing: Are You Risking GMP Compliance With The Water Bath Method?
As we move into 2015, cell therapy as a viable and profitable market is becoming more of a reality, especially with the increased focus on unmet medical needs offering the potential for small companies to find their niche in the industry. However, one of the challenges with working with cells, at both the research and clinical level, is the issue of variability that can occur during the thawing of cryopreserved cells. Overcoming this challenge would address issues with current methods, such as viability, contamination, and inconsistent results.
Merck Uses Automation And Disposables To Drive Upstream Process Development
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
Bayer Change Notification Process For Raw Material Supply Encourages Supplier Collaboration And Transparency
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.
Bioprocessing Technology Forum Offers Valuable Insight Into Industry Advancements
On October 1st and 2nd, the Upstream/Downstream Technology Forum, hosted by Sartorius, was held in Cambridge, MA. Industry leaders were given the opportunity at this event to cover topics focused on technological innovations in upstream and downstream bioprocessing, which allowed registered participants to come away with an increased awareness of the latest technical applications as well as upcoming new applications for existing technologies.
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?
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.