The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. The agency also introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.
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 FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. The agency also introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.
The biotechnology sector has seen important progress in the development of groundbreaking therapies in recent years, especially in the areas of immunotherapy and cell and gene therapy. In gene therapy alone, there are now clinical research programs targeting almost 50 different indications, up from only 10 a few years ago, and the rate of innovation is expected to continue to increase in the years ahead. A range of factors — including small patient populations, complex manufacturing processes, and lack of specialized expertise — are positioned to both drive up costs and require new options for stakeholder engagement and risk sharing along the development pathway. New approaches in development are needed to support the next generation of novel drugs on the horizon.
Manufacturers, suppliers, and regulators have recognized that introducing new technologies also introduces a degree of unfamiliarity and uncertainty.
In 2004, the FDA published an aspirational guidance for industry on process analytical technology. This article describes examples where industry has succeeded in meeting the FDA guidance.
This, the second installment in a series, covers factors in installing a liposome manufacturing process in a facility and the engineering points to consider in doing so.
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
By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences
The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.
Whey proteins play a vital role in the formulation of food supplements because of numerous desirable nutritional and functional properties. This case study depicts the establishment of a process workflow for whey purification using Nuvia S and Nuvia Q Ion Exchange Resins.
As the need for smaller plants, flexible manufacturing and competition intensifies in the biopharma industry, so does the need for intensified processes
At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.
Having sold filling lines for all types of liquid pharmaceutical products (hundreds of lines in aggregate), Bosch Packaging Technology is in a unique position to advise on filling system selection.
With their unique separation behaviors and tolerance for relatively high salt concentrations, mixed-mode resins have become important tools in the process developer’s toolbox.
