Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success. What would cause business partners to look at quality in such a way?
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.
Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success. What would cause business partners to look at quality in such a way?
Cell therapies, in particular, chimeric antigen receptor modified T cells (CAR-T), are showing enormous therapeutic promise, with cancer remission rates over 80 percent.1 This alone is forcing cell therapy manufacturing companies to develop strategies to build and scale up production at levels never contemplated before.
Counterfeit medications aren’t the only prescription drug-related threat to public health. If a legitimate product is not manufactured according to quality standards or becomes degraded as it travels through its supply chain, it can be ineffective at best or deadly at worst. However, separating the issues of counterfeit and substandard medications is a difficult proposition.
Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.
This is the second of two articles, this part focuses on the importance of cybersecurity and software maintenance, how time scales and methods of execution differ from those in traditional pharma, how agile software development works, and how to avoid potential pitfalls.
The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using single-use technology.
The production of mAb and recombinant proteins has undergone significant progress in recent decades. Higher titers and increasing cell densities present challenges to upstream and downstream groups alike.
A former FDA Biologics License Application reviewer and inspector focusing on microbiology, shares expert tips on how to best approach a bioburden problem when an FDA inspection is imminent.
Complex CMO networks are expensive and require many resources to manage. Plus, they prevent purchasing and operating at scale. Yet, the process of consolidating CMOs is daunting.
Discover the steps you can take to improve the quality of your chromatography sample prior to performing your column separation, to ensure optimal isolation of your target protein.
Bioprocessing development is a long and costly process. Building in continuous characterization and connected bioprocessing cuts timelines and increases the available information through real-time analytics.
A viable QMS cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete and easily retrievable.
