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

  • I Don’t Think The Word “Quality” Means What You Think It Means
    I Don’t Think The Word “Quality” Means What You Think It Means

    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.

  • Big Data & Leadership Strategies For Enabling Quality By Design
    Big Data & Leadership Strategies For Enabling Quality By Design

    The biopharmaceutical industry has unique commercial risks, including complex molecule products, costly supply chain infrastructure that takes a long time to construct, and raw material variations’ impact on process quality and yields.

  • Biocontainment: Understanding Biosafety Levels
    Biocontainment: Understanding Biosafety Levels

    This two-part article on biocontainment is a companion to our discussion of potent compounds, which focused primarily on chemically derived drug substances and drug components. While analogous to chemical potent compounds, biologically derived ingredients, intermediates, and products are produced by human manipulation of naturally occurring lifeforms and their byproducts.

  • Genome Editing & The Future Of Drug Discovery

    The genome editing market is estimated to reach $3.5 billion in 2019 — an increase from $2 billion in 2014 — with a CAGR of 13 to 14 percent.1,2 The factors driving this market include increased R&D funding for genomic research, a growing demand for synthetic genes, new technologies in genome editing, and high utilization in plant breeding. However, high regulatory stringencies, lengthy approval processes, and ethical issues associated with the fear of genetic research hamper market growth. This article examines the utilization of genome editing tools and technology and their impact across the drug discovery industry.

  • A Process Capability-Derived Scale For Assessing The Risk Of Compound Carryover In Shared Facilities

    This article presents a new scale for measuring the risk of compound carryover in shared facilities based on the process capability of a cleaning process that can be used to evaluate the probability of cross-contamination by compounds manufactured in a shared facility or equipment train.

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BIOPROCESSING WHITE PAPERS

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • How To Live With Uncertain Pharma Demand Forecasts
    How To Live With Uncertain Pharma Demand Forecasts

    The consequences of inaccurate demand forecasting can be reputational damage, market share loss, lost days of production, destruction of inventory, and layoffs.

  • The LAL Test: Precautions When Conducting Pharmaceuticals Research
    The LAL Test: Precautions When Conducting Pharmaceuticals Research

    For many decades, it has been found that the most effective method for determining pyrogens in pharmaceutical samples, regardless of the form of the active substance, is the LAL test. 

  • The Standardization Of Single-Use Components For Bioprocessing
    The Standardization Of Single-Use Components For Bioprocessing

    As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. 

  • Viral Safety Approaches For Advanced Therapy Medicinal Products
    Viral Safety Approaches For Advanced Therapy Medicinal Products

    Manufacturers safeguard biologic materials during the development process through a set of measures commonly referred to as the “Safety Tripod.”

  • Following FDA Guidance: Continuous Improvement In An Outsourced Environment
    Following FDA Guidance: Continuous Improvement In An Outsourced Environment

    In May 2013 the U.S. Food and Drug Administration (FDA) released its draft guidance, “Contract Manufacturing Arrangement for Drugs: Quality Agreements,” with recommendations representing its “current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.”

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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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