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

  • 5 Reasons External Collaborations Fail In Drug Discovery

    In an effort to accelerate innovation, streamline the R&D process, satisfy healthcare expectations and improve the rate of return, pharmaceutical companies have come to embrace external collaborations and their outsourcing partners as an essential part of their discovery programs. This trend towards externalization is significant with roughly 90% of companies outsourcing some steps of drug discovery, and with half of all drugs now resulting from such partnerships. This white paper, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.

  • How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management

    In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • It’s Time To Go Electronic In The Lab – Infographic
    It’s Time To Go Electronic In The Lab – Infographic

    The paper-based lab versus the digital lab. The largest barrier to innovation for any lab is performing tasks manually and recording experiment data in paper lab notebooks. Easy-to-use digital applications can increase productivity while reducing wasted time and inefficiencies associated with searching for relevant experiment data.

  • The Relationship Between The Chemical Nature Of Bacterial Endotoxins And Their Toxicity And Immunogenicity
    The Relationship Between The Chemical Nature Of Bacterial Endotoxins And Their Toxicity And Immunogenicity

    The diseases related to Gram-negative bacteria affect humans and animals and, in many cases, are difficult to treat, which is why is important to have effective and bacteria-specific antibiotics.

  • Missed Opportunities For Adventitious Agents Testing
    Missed Opportunities For Adventitious Agents Testing

    Current adventitious agent test methods feature numerous limitations. Assays based on polymerase chain reaction (PCR) offer the potential to lift these limitations and offer better overall detection of adventitious agents. This is an area that biologics manufacturers are actively exploring, and current research indicates that PCR-based testing is not only scientifically valid but also acceptable to regulators.

  • Site Selection And Development Utilizing A Colored Stop/Go Rated Matrix
    Site Selection And Development Utilizing A Colored Stop/Go Rated Matrix

    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.

  • Selecting The Optimal Resins For Aggregate Removal
    Selecting The Optimal Resins For Aggregate Removal

    The success of any biologic drug, for example, monoclonal antibodies (mAbs), recombinant proteins, or biosimilars, depends greatly on downstream purification. Among the challenges process scientists often face during this process is the formation and/or removal of aggregates of monomers.

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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