The revised format for the EU Risk Management Plan sets a new milestone in a progressive approach to risk management. The new RMP template is a straightforward and well-structured document that can be used by RMP experts, and the concepts behind risk management have been justified to better reflect the stages of the life span of a medicinal product.
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.
These top five events reflect the steps the numerous industry stakeholders are taking to build what they hope will be a biosimilar friendly framework in the U.S. Though a number of these developments could bring positive implications for the biosimilar industry moving forward, several of these have raised a number of questions and concerns.
The revised format for the EU Risk Management Plan sets a new milestone in a progressive approach to risk management. The new RMP template is a straightforward and well-structured document that can be used by RMP experts, and the concepts behind risk management have been justified to better reflect the stages of the life span of a medicinal product.
Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. If disinfectants are not used properly, microorganisms may remain on surfaces and proliferate in the environment. This article discusses the concept of disinfectant rotation and the current mainstream industry practice regarding it.
Gone are the days when we could count the number of immunology drugs on the market with our two hands. Today, the market is crowded with not only an abundance of originator biologics, but also an increasing supply of biosimilar products
Having a competent, professional workforce is essential to meeting the dual goals of business requirements and regulatory expectations. With a coherent plan and a well-structured learning system that is focused on performance, a pharma firm can efficiently accomplish both.
Mylan’s roots are firmly based in the small-molecule generics business; however, the company has positioned itself as a strong competitor in the biosimilar field with the help of key strategic partnerships in recent years. This article explains how the company expanded its access to different biosimilars and given it more rapid access to key biosimilar markets.
Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.
With so many connection options, it can often be an overwhelming task to decide which connector is best suited for a specific application. By understanding your application requirements and selecting the correct connection type, you will have better performance and sealing results. By Colder Products Company
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.
Over the years, adoption of single-use has emerged as one important strategy for improving downstream and upstream processing while avoiding the downsides of traditional stainless-steel bioreactors.
Single use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits. In some ways, will cell and gene therapy manufacturing be similar to biopharmaceutical manufacturing? What are the key differences and gaps in learning?
How far have we come in raw material supply management, and what still needs accomplished to ensure the delivery of safe and effective drugs?
Upstream processes must be robust to ensure high batch success rates with a low risk of contaminations and minimal variations in cell growth performance.
