Quality Systems

Excipients Impact Stability in mRNA-LNP Formulations

March 03, 2023

Lipids aren’t the only important ingredients influencing stability and in vivo performance.

Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>

March 02, 2023

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Taking Steps Toward Supply Chain Continuity

March 02, 2023

Stockpiling excess inventory is no longer enough to respond to supply chain volatility.

Vaccine Development Builds on COVID-19 Breakthroughs

March 02, 2023

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

EMA Guidance on Paediatric Investigation Plans

March 02, 2023

Stepwise paediatric investigation plans aim to boost the development of medicines for children.

Securing the Supply Chain with Good Distribution Practices

March 02, 2023

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

Subsurface Currents

March 02, 2023

That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.

AbbVie Receives Positive CHMP Opinion for Crohn’s Disease Treatment

March 01, 2023

CHMP recommended the approval of AbbVie’s RINVOQ (upadacitinib) as a treatment for adults with moderate-to-severe Crohn’s disease.

Designing Potency Assays for Complex Novel Modalities

March 01, 2023

The further we pursue CGT, the more variability we need to account for in order to engineer consistency into these new products.

Investigational Personalized mRNA Cancer Vaccine Gains Breakthrough Therapy Designation from FDA

February 28, 2023

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.