Development

Articles

Bridging the gap between R&D and GMP

Companies prioritizing optimized synthetic routes, stable API forms, and verified analytical tools set the stage for phase I clinical manufacturing success

7 challenges of NGS-based biomarkers

Next generation sequencing has unprecedented power in biology, but has yet to reach its full potential in medicine

Alleviating bottlenecks in the product life cycle

How the adoption of AI and data-driven techniques can increase efficiencies in pharma manufacturing

FDA decisions to watch in 2023

The agency is facing a busy year, with potential novel drug approvals ranging from gene therapies to RSV jabs

Beyond empty and full

The field is in need of more detailed product understanding to increase product safety without sacrificing efficacy

News

FDA hands Biohaven refusal to file letter

AZ, Sanofi closing in on first approval for RSV in 23 years

Novo teams with Aspect on bioprinted diabetes treatments

FDA approves BMS psoriasis TYK2 inhibitor

Fresenius Kabi snags its first biosimilar approval

Bridge Bio, Brainomix partner to use AI in lung fibrosis trial

Ensuring business continuity in the lab

How modern chromatography data systems can help mitigate disruption

Advancing nanomedicine

Research into nanomaterials has opened the door to new therapeutic strategies

Quantifying technology’s impact on vaccination rates

How reducing technology-addressable vaccine barriers affects coverage rates

Planning your oligonucleotide facility

Two key facility considerations that will impact pharma’s business case

Developing a cell and gene therapy packaging strategy

Optimal packaging and labeling solutions help ensure the delivery of safe, effective viral vector products

Toward a collaborative pharma ecosystem

A new biomanufacturing era demands that suppliers and manufacturers partner to efficiently bring new therapies to market

mRNA boom: A double-edged sword

Did short-term solutions for COVID-19 stifle long-term mRNA success?

10 tips for improved drug development

Comprehensive strategies to save time and reduce cost in end-to-end clinical development

Pulling antibiotics from the fire

Can policy reform save a market in peril?

Taking a QbD approach to packaging development

Phase change material in cold chain packaging offers big benefits, but getting there requires a data driven approach