EDITOR'S DESK

  • Building Thailand’s Biosimilar Industry From The Ground Up
    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.   

A Deep Dive Into Brazil’s Biosimilar PDPs

In terms of life sciences, Brazil is best known as a small molecule pharmaceutical market; some of the largest companies in Brazil are small molecule generics companies. But, in recent years, the country has identified the importance of establishing a biotechnology industry. Enter the productive development partnerships (PDPs). 

A Glimpse Into Thailand’s Ongoing Life Sciences Transformation

During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.

What Thailand Revealed About U.S. Pharma R&D

A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.

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GUEST CONTRIBUTORS

  • 7 Steps To Properly Navigate An Event Investigation
    7 Steps To Properly Navigate An Event Investigation

    A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree.

  • Practical Application Of Online Water Bioburden Analyzers In Pharmaceutical Manufacturing
    Practical Application Of Online Water Bioburden Analyzers In Pharmaceutical Manufacturing

    Water is the single largest quantity raw material used in pharmaceutical manufacturing. Water is used in all facets of manufacturing, from preparing equipment to manufacturing the final commercial product.

  • An Evaluation Of A Closed Sterile Transfer Process For Aseptic Filling
    An Evaluation Of A Closed Sterile Transfer Process For Aseptic Filling

    Critical control points for conventional aseptic processing are most often related to contamination resulting from human intervention and exposure of critical surfaces before and during fill. Extensive resources are required to install and maintain controls for these typical failure modes which can lead to two critical issues: shortages of essential medicines and inability to meet the timelines critical to control emerging pandemic threats.

     

  • Supreme Court Biosimilar Decision — What Developers Need To Know

    When the U.S. Supreme Court granted certiorari in the Sandoz v. Amgen litigation earlier this year, many were hoping for a decision that would clarify some key issues pertaining to the requirements of the BPCIA. But the decision left a number of questions unanswered.

  • How To Establish An Aseptic Gowning Qualification Program

    Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This four-part article provides a foundational introduction to some of those aspects.

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BIOPROCESSING WHITE PAPERS

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • The Changing Biopharma Risk Equation
    The Changing Biopharma Risk Equation

    As pharma companies expand, they are looking more and more to biologics for their next potential blockbusters. However, this class of product—ranging from well-established large molecule drugs to truly novel therapies—poses major challenges because of their scientific complexity and sophisticated development requirements.

  • Exploring Collaboration With Third Parties And The Impact On Document Management
    Exploring Collaboration With Third Parties And The Impact On Document Management

    The trend towards virtual pharma is accelerating and as it does, the life sciences industry is undergoing a profound structural change. The areas of development and commercialization which were once conducted within the confines of one company have now become a collaboration within an ecosystem of entities, both public and private.

  • Autologous Cell Therapies At A Crossroads With The FDA: What Can You Do to Help?
    Autologous Cell Therapies At A Crossroads With The FDA: What Can You Do to Help?

    Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies onsite. What does the pharmaceutical industry need to know — and, more importantly, do — to overcome it?

  • How To Rapidly Create Single-Use Biomanufacturing Capacity
    How To Rapidly Create Single-Use Biomanufacturing Capacity

    To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.

  • Tips For Preparing And Using Buffers With Your Chromatography System
    Tips For Preparing And Using Buffers With Your Chromatography System

    One of the important and often overlooked tips to increase the performance of a chromatography system is to understand how to best use and prepare buffers and solvents.

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LIFE SCIENCE INDUSTRY EVENTS

Drug Development 101 – How A Drug Is Made August 3, 2017
1pm-2:30pm EDT, Online Training
Cell Therapy: Process Design Considerations To Support Commercialization August 9, 2017
1pm-2:30pm EDT, Online Training
Effective Batch Record Review - Getting It Right The First Time August 14, 2017
1pm-2:30pm EDT, Online Training
Using Social Media for Patient Recruitment in Clinical Trials August 15, 2017
1pm-2:30pm EDT, Online Training
FDA GMP Inspections – Proven Preparation & Survival Techniques August 29, 2017
1pm-2:30pm EDT, Online Training
More Industry Events

TRAINING COURSES

Drug Development 101 – How A Drug Is Made August 3, 2017
1pm-2:30pm EDT, Online Training
Cell Therapy: Process Design Considerations To Support Commercialization August 9, 2017
1pm-2:30pm EDT, Online Training
Effective Batch Record Review - Getting It Right The First Time August 14, 2017
1pm-2:30pm EDT, Online Training
Using Social Media for Patient Recruitment in Clinical Trials August 15, 2017
1pm-2:30pm EDT, Online Training
FDA GMP Inspections – Proven Preparation & Survival Techniques August 29, 2017
1pm-2:30pm EDT, Online Training
More Upcoming Courses