Quite a bit has been written about data integrity in recent years, and an embedded, effective quality culture remains a critical success factor for fully realizing strong data integrity. In recently published guidance on data integrity, the FDA goes so far as to state very directly that “it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues.”
Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.
I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.
Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.
Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"
Quite a bit has been written about data integrity in recent years, and an embedded, effective quality culture remains a critical success factor for fully realizing strong data integrity. In recently published guidance on data integrity, the FDA goes so far as to state very directly that “it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues.”
This is the third of three articles focusing on an effort to address what appear to be systemic issues across quality departments, informed by a multinational group comprising chief quality officers (CQOs) from pharma, device, animal health, and consumer goods companies. It will examine how to achieve cross-functional ownership of quality and the efforts of the CQO team to build quality for the 21st century, including exploring the creation of formal degree programs in quality.
Using new and existing technologies to improve aseptic processing manufacturing may provide the need and opportunity for new approaches to process control and monitoring. In some cases, improvements to these approaches will require the use of existing technology. In other cases, they will be required to support the implementation and use of new technology.
A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.
Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.
Today’s chemical development labs are busy places that create fascinating new chemicals, new formulations and new products that boost the bottom line. But are these labs as efficient as they could be?
If you have asked and answered these five questions, and are using a rigorously designed and qualified shipping system, then the data will provide an objective affirmation that you performed due diligence and significantly advanced the commercial success of your product.
By applying remote monitoring, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers process reliability and product quality through connecting machines and data.
The large buffer volumes required for biomanufacturing can be a bottleneck, especially when scaling up. Just-in-time buffer preparation can be the solution.
Can high density cryopreservation allow biopharma manufacturers to buy back time? The answer is “yes” – and specialized media (both catalogue and customized) for perfusion processes are being designed for this purpose.
Not Seen on HGTV: Method Design for Cell Assays. The many decisions when designing cell-based potency assays make home remodeling look easy.
Manufacturing viral vector-based therapies such as vaccines and gene and cell therapies is complex, but a new manufacturing solution helps solve those challenges.
