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Nicole Dale

Next-Generation Sequencing for Cell Line Development in Biologics Manufacturing

Discover how next-generation sequencing in cell line development is improving biologics manufacturing, quality control, and regulatory confidence.

Biologics

Read AAV Vector Manufacturing: Solving Gene Therapy's Bottleneck

Nicole Dale

AAV Vector Manufacturing: Solving Gene Therapy's Bottleneck

Scientist’s gloved hands handling a vial and pipette in a bright laboratory with a glowing DNA helix and AAV capsid, representing advanced AAV vector manufacturing and gene therapy process development.

Discover how innovations in AAV vector manufacturing are improving scalability, quality, and commercial readiness for next-generation gene therapies.

Cell and Gene Therapy

Read Foundational AI In Cell and Gene Therapy Development Success

Nicole Dale

Foundational AI In Cell and Gene Therapy Development Success

Discover why AI in cell and gene therapy is necessary for successful development by improving drug discovery, viral vector engineering, manufacturing, and quality control.

Cell and Gene Therapy

Read FDA Registration for Drug Manufacturing Enters a New Era

Nicole Dale

FDA Registration for Drug Manufacturing Enters a New Era

Modern pharmaceutical manufacturing facility with stainless steel equipment, automated vial conveyor, and red digital data wave overlay symbolising FDA regulatory oversight and digital quality systems.

The FDA's proposed drug manufacturing modernisation rule could accelerate distributed manufacturing, digital quality systems, and pharma supply chain resilience.

Decentralised Manufacturing

Read Is AI Quietly Creating a GDPR Crisis in Clinical Research?

Shubhangi Dua

Is AI Quietly Creating a GDPR Crisis in Clinical Research?

Generative AI is transforming clinical trials, but a failure to distinguish between pseudonymised and anonymised data is creating costly regulatory gaps.

Clinical Data

Read Optimising Clinical Trial Data Collection for Better Decisions

Nicole Dale

Optimising Clinical Trial Data Collection for Better Decisions

Optimising clinical trial data collection Pharmatica image representing fit-for-purpose evidence generation.

Learn how optimised clinical trial data collection improves data quality, reduces protocol and patient burden, and supports smarter clinical development.

Clinical Data

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