EDITOR'S DESK

  • Russia’s Biosimilar Market At A Glance
    Russia’s Biosimilar Market At A Glance 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.
Plant-Based Biosimilar Development Takes Root In Brazil

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.

How To Handle The Impending Biosimilar Pipeline Boom

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.

Building Thailand’s Biosimilar Industry From The Ground Up

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.

The Thai FDA’s Approach To Biologics And Biosimilars
This article examines Thailand's history with biologics and biosimilars, as well as Siam Bioscience's perceptions of the current Thai FDA biologics and biosimilar regulations in relation to the U.S. and EU.
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GUEST CONTRIBUTORS

  • An Introduction To Environmental Monitoring & Cleaning For Aseptic Environments
    An Introduction To Environmental Monitoring & Cleaning For Aseptic Environments

    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.

  • What To Expect From Artificial Intelligence In Pharma — And How To Get There
    What To Expect From Artificial Intelligence In Pharma — And How To Get There

    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.

  • Strategies For Commercial Success In The Global Biosimilar Market
    Strategies For Commercial Success In The Global Biosimilar Market

    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.

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BIOPROCESSING WHITE PAPERS

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INDUSTRY INSIGHTS

  • Comprehensive Solutions For Aggregate Issues
    Comprehensive Solutions For Aggregate Issues

    The success of any biologic, such as monoclonal antibodies (mAbs), recombinant proteins, or biosimilars, depends greatly on downstream molecule purification. Process scientists often face multiple challenges during this process, including the formation of aggregates.

  • Pharma Seeks Long Tail Of Flexible Manufacturing
    Pharma Seeks Long Tail Of Flexible Manufacturing

    It is no secret that pharma lags behind other industries when it comes to innovation in manufacturing, but the industry does have its eye toward new models of manufacturing.

  • 10 Sustainable Lab Solutions To Implement Today
    10 Sustainable Lab Solutions To Implement Today

    Explore several low-cost, high-impact strategies that an institution can implement to reduce a building’s carbon footprint and improve operational expenses—even without large-scale upgrades.

  • CDMOs — At The Core Of Next-Generation Pharma Models
    CDMOs — At The Core Of Next-Generation Pharma Models

    In today’s pharmaceutical industry, the economic strains of keeping a company completely vertically integrated are no longer feasible. Smaller, virtual drug companies simply do not have the resources necessary to translate a molecule to a drug product.

     

  • Keeping Your Cool When Storing Purified Protein
    Keeping Your Cool When Storing Purified Protein

    The study of proteins and their function is central to understanding biology, but separating and purifying single proteins from complex mixtures is hard work. After investing the time to purify your target protein using various chromatography methods, losing your protein integrity because of improper storage would be devastating. Good storage conditions are particularly important if you need your protein for several downstream studies. You might need to store your preparation for an extended period of time, and some experiments require that the protein retain its original structure, binding affinity or enzymatic activity. Here we discuss some quick and simple suggestions relating to concentration, additives, sample size and storage temperature to consider when storing your protein for future use.

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LIFE SCIENCE INDUSTRY EVENTS

FDA GMP Inspections – Proven Preparation & Survival Techniques August 29, 2017
1pm-2:30pm EDT, Online Training
Cleanroom Microbiology – A Foundational Introduction September 12, 2017
1pm-2:30pm EDT, Online Training
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