Drug Development

Articles

EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically. 

EMA Aims to Develop Guideline for mRNA Vaccines

The acquisition will continue to strengthen the area of conjugate vaccines and bioconjugate drugs and will expand Biosynth’s capabilities from good manufacturing practice facilities located in Berlin, Germany.

Biosynth Acquires Celares for Growing Conjugate Vaccine Market

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Podcasts

In this episode, Sergey Vlasenko from Agilent chats about bio/pharmaceutical manufacturing trends, with a particular focus on oligonucleotides.

Drug Solutions Podcast: Unlocking the Latest Manufacturing Trends

Feliza Mirasol is the science editor for 

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

Using Analytical Advancements to Assess Biosimilarity

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Sample dilution, sensitivity, excipient interference, and containment are key issues that must be addressed.

Overcoming Analytical Challenges in High Potency Formulation

Michael Schrader, CEO and co-founder of Vaxess, discusses the latest on vaccine administration and different ways the pharmaceutical industry can distribute these products with Pharmaceutical Technology editor Jill Murphy. 

Drug Solutions Podcast: Emerging Methods of Vaccine Administration and Distribution

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Videos

Chris Spivey, editorial director, speaks with Sean Hart, CEO and SCO of LumaCyte, on percent transduction for AAV measured.

Transduction for AAV with Sean Hart

World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration. 

mRNA Global Alliance Tests the Waters at BIO

invoX Pharma has made a second tranche of investment in pHion Therapeutics to support further development of next-generation mRNA vaccines.

Formulation and Drug Delivery