Part 3 of Identifying And Resolving Errors, Defects, And Problems Within Your Organization — a five-part series on operationalizing proper improvement techniques.
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?"
Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.
Part 3 of Identifying And Resolving Errors, Defects, And Problems Within Your Organization — a five-part series on operationalizing proper improvement techniques.
With the recent breakthroughs in cell and gene therapy, there is increased emphasis on the design and implementation of different supply chain models to support the movement of materials and drug product across the chain of care. Unlike more traditional supply chains, many of these therapies have unpredictable sources and manufacturing and infusion locations. The most extreme example is loosely referred to as the “vein-to-vein” supply chain — particularly for autologous therapies.
Probably one of the most significant developments in sterilization and aseptic practices in pharma is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.
This article summarizes the key provisions of the new law and discusses its limitations. I then look at the FTC’s practice in evaluating “reverse payment” settlements in Hatch-Waxman litigations and discuss why similar antitrust analyses of biosimilar settlements will likely be more complex.
The EMA Q&As and their updates mark an important turning point in the pharmaceutical industry regarding cleaning validation and quality risk management. The new ASTM standards will provide guidance to the industry on the appropriate development of health based exposure limits, for the implementation of science- and risk-based approaches to cleaning validation, and on the use of statistical techniques for measuring the risk in cleaning and assessing the effectiveness of cleaning processes.
Leak testing of SUS or biocontainers, post-installation and prior to actual use, reduces the risk that a system or a biocontainer which may have been damaged during shipping, receiving, handling, storage, or installation could contribute to valuable product loss. Therefore, in cases involving high value product or complex multiple operations, leak testing may be recommended prior to use at the end-user site. This document serves to provide general guidance for experimentally establishing leak test maximum flow for SUS tested at the end-user site. It is intended to assist users in the development of parameters and maximum flow for the leak test of single-use systems when using the Palltronic Flowstar LGR test instrument.
How can end users ensure the expected level of compliance in this new world of single-use systems? The secret: shared responsibility for validation with your supply chain.
Understanding the volume and complexity of data created throughout the scientific process is key.
Companies are increasingly looking towards more holistic solutions, as they realize that all data is part of the same, bigger picture. For R&D organizations, data is the new gold.
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.
Currently, there is a transformation taking place that will pave the way for even more changes to how the industry approaches drug manufacturing.
While single-use processing has limitations with scale of operations when compared to stainless steel setups, several trends are mitigating the impact of these limitations significantly.
