One of the most intriguing experiences we have had in our business in the last 20 years is being faced with a seemingly simple water-soluble topical or device component fill and then being told it is an organic peroxide! When we in our nice, safe water-based business (leave out liposomes) are faced with the compounding fire/electrical/OSHA compliances along with our GMP issues, it starts to read like a 1940s detective mystery.
Though there is a large handful of countries that, to date, don’t have biosimilar pathways established, a few countries have been slowly gearing up to be leaders in paving the way for biologics and biosimilars. In this article, I’ll discuss the potential of these three markets, as well as the business considerations Challand highlighted for companies considering entering the MENA region.
Throughout her presentation, Challand gave us a good look at the current state of the biologics market in MENA and the ongoing educational and collaborative efforts that could help shape the markets in this region. She also shared several important considerations for regulators and biosimilar companies looking to expand their business to MENA.
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.
One of the most intriguing experiences we have had in our business in the last 20 years is being faced with a seemingly simple water-soluble topical or device component fill and then being told it is an organic peroxide! When we in our nice, safe water-based business (leave out liposomes) are faced with the compounding fire/electrical/OSHA compliances along with our GMP issues, it starts to read like a 1940s detective mystery.
Since the introduction of similar biological medicinal products in the EU in 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the United States. How does the rise of the China biosimilars market fit into this established picture?
CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.
ASTM standard E2500, Specification, Design, and Verification of Pharma and Biopharma Manufacturing Systems and Equipment, elevates risk-based validation as a critical aspect of GMP manufacturing. This article explores validation’s role in efficiency and cost management, in an approach to ASTM E2500 from a scientific, value-added perspective
Despite the best efforts of those directly responsible for data integrity, human error will still find its way into the equation and undermine the efforts. The potential for human error is directly and indirectly impacted by the corporate culture, the national/regional culture, and the quality culture of an organization.
Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex.
Three considerations to give you confidence when selecting fluid handling connectors for your bio application.
The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.
By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
How a customer focused mission to boost single-use assembly product quality and supply security led to the Mobius® MyWay Program and a manufacturing site transformation.
With today’s complex manufacturing systems and processes, can a manufacturer afford to not have a centralized automation platform?
