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.
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?"
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.
“Skinny labeling” refers to the practice of follow-on drug manufacturers seeking approval for some but not all the indications for which the branded drug has been approved. In the small molecule drug world, it has been a successful strategy for generic drug makers to get around the brand’s follow-on “new use” patents that keep the brand from falling off the “patent cliff” long after the expiration of the original patents. This strategy is starting to be used in the biosimilar realm.
Finite Element Analysis (FEA) has been widely used to analyze the in vivo structural response of implantable medical devices and assess device performance, reliability and durability. In order to obtain a robust design, parameter variations and their influence on device performance need to be understood. Probabilistic analysis techniques like Monte Carlo sampling combined with FEA clarify these stochastic processes and in determining probability of failure and design reliability. In this study, FEA using Abaqus is combined with statistical and probabilistic analysis using Isight to demonstrate how these techniques work together to evaluate the robustness of medical device designs.
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.
While a prefilled syringe offers many advantages for biologic products, manufacturers must evaluate the potential impact of a prefilled syringe on product quality prior to selecting the final components.
Using its Supplier Relationship Excellence (SRE) program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to better understand operational performance.
How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time to market.
Understanding the different considerations for bioburden control in various operations and production steps can help define a strategy for successful production.
Using scale-up strategies that consider certain challenges, in combination with truly scalable bioreactor equipment can offer efficient approaches to scaling-up bioprocesses from early development to final production.
