ARTICLES BY TRISHA GLADD
Merck’s Vision Behind Award-Winning Technology And Partnership For High Throughput 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.
FDA Outlines Upcoming Regulatory Changes And Urges Industry To Be Proactive And Transparent
While reviewing upcoming changes heading industry’s way through regulatory legislations, such as the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Drug Supply Chain Security Act (DSCSA), during her keynote session at Pack Expo 2014, Ricki Chase, director of investigations for the FDA’s Chicago office, urged the audience to not just focus on product integrity, but also personal and corporate integrity.
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.
HDMA Conference Examines A Holistic Approach To DSCSA Preparation
As the first Drug Quality and Security Act deadline approaches, pharma professionals around the globe are offering insight and advice in order to help with preparation for this legislation. While any Google search will return pages of helpful articles, the most beneficial information will be offered in real time at conferences and seminars arranged by industry organizations. One example of this is the 2014 Healthcare Distribution Management Association (HDMA) Education Traceability Seminar taking place in Arlington, VA from November 10th to the 13th. According to its site, the seminar will “include valuable insights, innovative approaches, and lessons learned as distributors and manufacturers successfully implement serialization and traceability technologies.”
2nd Draft Guidance Under DSCSA Offers Clarity For 3PLs As January Deadline Approaches
Earlier this month, the FDA announced the availability of the second draft guidance under the Drug Supply Chain Security Act (DSCSA), titled The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers. While clarifying information is provided, the guidance is still in draft form and more information from industry will need to be collected in order to drive it to a finalized state.
Supply Chain Security: 3 Visions To Prevent Fraud And Safeguard The Patient
The vulnerability of the pharmaceutical industry’s supply chain has been talked about in great depth, especially since the passing of the Drug Quality and Security Act (DQSA) last November. Millions of stolen, counterfeit, and illegal medications infiltrate pharma’s shipping lanes every year, and despite all of the buzz, experts are pumping out viable solutions at a much slower rate than criminals are distributing contaminated and/or fake drugs.
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.