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Cell and Gene Therapy

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Volume 5 Issue 4

Managing the Transition to Next-generation Sequencing

Dr. Ģirts Šķenders and Mr. Reinis Zeltmatis shed light on how the COVID-19 pandemic brought significant changes to their hospital laboratory. Upgrading it in the mids...
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Volume 5 Issue 4

Preparing for Success – How to have a positive FDA Inspection

Success does not come about by coincidence. Success is an outcome of preparation. When it comes to successful U.S. Food and Drug Administration (FDA) inspection outco...
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Volume 5 Issue 4

Ensuring Success in Pharmacovigilance and Patient Safety

Best practices for sponsor and CRO alliances in a demanding industry Outsourcing all or part of the pharmacovigilance (PV) and patient safety services required durin...
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Volume 5 Issue 4

Integrated Laboratory Informatics – Are Organisations Really Exploiting the Benefits?

The ideas behind integrated laboratory informatics are not new, but there are serious questions as to how many organisations are fully, or even partially, realising t...
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Volume 5 Issue 4

SLP’s Use in the Pharmaceutical World

Introduction to Silkworm Larvae Plasma (SLP) The silkworm, Bombyx mori, has an interesting defense against bacterial and fungal invasion. This defense is found in th...
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Volume 5 Issue 4

Trends Paving the Way for an Influx of Biosimilar Development

Promising broader patient access to critical medicines, biosimilars offer a more cost-effective alternative therapeutic option compared with originator products. With...
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Volume 5 Issue 4

How do we Address Product Finishing and Dispensing Challenges for Future Pandemics?

The refinement of sterile manufacturing processes had a central part to play in enabling the pharmaceutical industry to successfully deliver billions of doses of COVI...
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Volume 5 Issue 4

How Do You Build an AAV Manufacturing Platform?

Gene therapy represents an expanding area of medicine with the potential to change the lives of people with life-limiting conditions. As the interest in gene therapie...
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Volume 5 Issue 4

Looking Beyond Plasmids: What’s on the Horizon for Gene Therapy Manufacture?

Plasmid-based methods have, for good reason, been a trusted method for the manufacture of adeno-associated viral (AAV) vectors for many years. As 2022 closes and we l...
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Volume 5 Issue 4

Strategies for Simplifying Biopharma’s Digital Journey

The biopharma industry requires digital transformations to improve efficiencies and deliver critical therapeutics to patients at an accelerated rate. Although great e...
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