Current Edition


Shoring up Diagnostics Manufacturing for the Next Pandemic

As the global response to COVID-19 continues to move from a state of national lockdowns to the re-opening of societies, diagnostic assay developers are confronting …

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Drug Patent

4 Drugs Facing Key Patent Expirations and Potential Generic Entry From September 2021–November 2021

A challenge in anticipating generic entry is elucidating which patents and regulatory protections constrain generic entry. Yali Friedman at DrugPatentWatch presents a set of an …

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Small Biotechs

Divided by a Common Language: PV Differences Between the UK and the US – Notes for Ambitious Biotechs

In the modern market, small and nimble biotechs possess many great advantages in terms of their ability to bring new innovation to market quickly, unhindered …

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cell and gene therapies

Regulatory Challenges Associated with the Development of Cell and Gene Therapies

The development of safe and effective cell and gene therapies (CGTs) relies on regulatory compliance and critical selection and qualification of raw materials. Regulatory classifications …

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How to Bring Your Oncolytic Virus Innovation to Market: the Secret to Successful Development

Cancer continues to be a major burden on healthcare systems across the world, with global spending on therapies and supportive care drugs expected to reach …

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CRISPR-Cas9 Knockout Screening Using Primary Human Cells in Drug Discovery

While significant progress has been made carrying out CRISPR screens in immortalised cell lines, a more physiological and clinically relevant alternative is human primary cells, …

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CAR-T cells

Are We Nearly There Yet? The Ongoing Journey of CAR-T Cell Therapies

CAR-T cells have a genetically engineered T-cell receptor (TCR) that directs their binding to cancer cells. In first-generation CARs, the TCR was engineered to express …

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cellular machinery

Viral Vector Engineering to Improve Clinical Performance and Accelerate Timeline to Success for Novel Gene Therapies

Viruses are known to be dangerous pathogens which invade host cells and hi-jack their cellular machinery to direct the replication and transcription of their own …

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E&L Standards

E&L Standards: Empowering Confident Labware Choices

All labware has some extractable and leachable content. It is important to recognize that extractables and leachables are two different things. Extractables are organic compounds …

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Residual Impurities in Biopharmaceutical Products

Process-related impurities or residual impurities are formed at any time during upstream or downstream processes. They are compounds that are present at very low concentrations …

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Innovations in Cell Line Development to Optimise Biotherapeutic Development

Developing stable and high-producing cell lines to manufacture biologics is complex, multi-stage, and time-consuming, often resulting in development timelines that exceed six months when using …

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Big Memory technology

Accelerating Single-Cell Genomic Sequencing with Big Memory

When fighting the global spread of a pandemic or working to fight cancer, faster time-to-discovery saves lives. For this critical bioscience work, scientists have employed …

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