As biosimilars finally move into mainstream commerce in the world’s major (bio)pharmaceutical markets, they are bringing with them some side benefits. Because biosimilars generally need to be manufactured cost-effectively, their sponsors frequently focus resources on production technologies that generate higher productivity and yields. Some of these cutting-edge technologies are applicable to mainstream pipeline biologics, so future biopharmaceuticals will benefit from this push for efficiency.
After my discussion with BIOCAD's Roman Ivanov, it’s clear the Russian biosimilar market is a prime example of the positive impact biosimilars can have on a nation. However, Russia's biosimilar market has evolved quite differently than those of the EU and U.S.
In June 2017, Canadian company PlantForm announced it was beginning construction for a pilot biologics and biosimilar manufacturing facility in Brazil. Given Brazil’s ongoing efforts to establish a local biotechnology industry, I reached out to learn more about PlantForm’s progress in navigating the regulatory landscape to bring its biosimilars closer to market.
There is no cut-and-dried approach to launching a biosimilar globally. It comes down to having the right commercial model for the right product in the right channel in the right market. But knowing what is “right” will be a particular stumbling block for many companies.
As the first of this two-part article revealed, the biosimilar market has undergone several revolutions since the release of the Thai FDA’s biosimilar guidelines in 2013. During our tour of Siam’s facilities, the company’s managing director, Songpon Deechongkit, Ph.D., shared the company’s history, overall biosimilar strategy, and some of the pros and cons of being the first and only biosimilar company in Thailand.
As biosimilars finally move into mainstream commerce in the world’s major (bio)pharmaceutical markets, they are bringing with them some side benefits. Because biosimilars generally need to be manufactured cost-effectively, their sponsors frequently focus resources on production technologies that generate higher productivity and yields. Some of these cutting-edge technologies are applicable to mainstream pipeline biologics, so future biopharmaceuticals will benefit from this push for efficiency.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. This article will address concepts of environmental monitoring and the importance of disinfectant efficacy and proper cleaning in cleanrooms.
Artificial intelligence (AI) has truly moved from concept to reality in the pharmaceutical industry. Many companies are already using AI to pour through mountains of scientific data in an effort to speed and improve the drug discovery process. And the technology is starting to find new applications in areas as diverse as regulatory/compliance, clinical trials, manufacturing, and supply chain.
An article recently published on Biosimilar Development identified and described six company archetypes that currently make up the biosimilar market: opportunists, bio powerhouses, biosimilar machines, generic giants, bio wizzes, and genericists. We liked this concept so much that we reached out to biosimilar experts from several prominent management consulting firms to ask for their perspectives on these archetypes, emerging biosimilar development and business strategies (as well as mistakes to avoid), and the market’s future.
The word “quality” is bandied about with reckless abandon across the healthcare, clinical practice, pharmaceutical, and biotech industries. Everyone thinks they understand quality at a deep level, just like everyone thinks they are “better than average” drivers.
Multivariate Statistical Process Monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment. By Dr Frank Westad, Chief Scientific Officer, CAMO Software
Chemical engineering is a discipline that to a certain degree relies on deterministic or first principle models. By Dr. Frank Westad, Chief Scientific Officer, CAMO Software
The recent Economist Intelligence Unit survey revealed that biopharma companies of all sizes share many of the same hopes and concerns. Yet many of the risk concerns and routes to growth are unique for small biotechs as they survey the changing industry landscape. We spoke with Ruta Waghmare – Global Director, Emerging Biotechnology at MilliporeSigma – about global funding trends, the evolution of virtual biotech companies, and taking control over your own molecule.
Due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.
Artwork must be right the first time and every time. Even a simple mistake has the potential to be catastrophic, resulting in product recalls, fines, write-offs and potential lawsuits.
How to incorporate a new process into an existing facility is a basic question that begins every project. The client usually has a preconceived idea of where a new process will go and how much space is available, but if we stop here and do what we are told, preconceived notions may drive us to a point where we find that project needs haven’t been met.
A single vendor offers access to a network of experts across several disciplines who can share knowledge about a project as it moves from phase to phase, thus helping to navigate its path toward commercial success. Following a CPhI North America panel about single-source CDMOs, Paul Nelson, vice president of supply chain and R&D at Amring Pharmaceuticals, discusses his experience with single-source CDMOs.
