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Volume 4 Issue 3

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 tw...
1 September 2021 Volume 4 Issue 3 COVID-19 | Disease
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Volume 4 Issue 3

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...
1 September 2021 Volume 4 Issue 3 Drug Patent | Drugs
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Volume 4 Issue 3

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 by legac...
1 September 2021 Volume 4 Issue 3 Small Biotechs | Start-ups
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Volume 4 Issue 3

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. Regula...
1 September 2021 Volume 4 Issue 3 cell and gene therapies | cell therapies
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Volume 4 Issue 3

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 $200 billi...
1 September 2021 Volume 4 Issue 3 development | innovation
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Volume 4 Issue 3

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 pri...
31 August 2021 Volume 4 Issue 3 CRISPR | development
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Volume 4 Issue 3

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 expres...
31 August 2021 Volume 4 Issue 3 CAR-T cells | development
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Volume 4 Issue 3

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 geno...
31 August 2021 Volume 4 Issue 3 cellular machinery | Clinical Performance
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Volume 4 Issue 3

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 organ...
31 August 2021 Volume 4 Issue 3 E&L Standards | E&L testing methods
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Volume 4 Issue 3

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 conc...
31 August 2021 Volume 4 Issue 3 biomanufactured | manufacturing
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