Multiple types of highly potent biologics require specialized manufacturing skills.

Assessing Risk and Production of Potent Substances

A fixed-dose combination tablet was prepared by a quality-by-design approach using two-level factorial design.

Using QbD to Develop Fixed-Dose Combination Tablets 

Topical drugs are attractive to patients but pose challenges for formulators.

The Art and Science of Topical Drug Formulation

Topic

Articles

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.

EC Orders 150 Million Additional Doses of Moderna’s COVID-19 Vaccine

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.

EMA Issues Positive Opinion for CrisBio Developed Vaccine, Validating the Platform

Vectura has signed an agreement with Incannex Healthcare for the pre-clinical development of IHL-216A, an inhaled drug product for the treatment of traumatic brain injury.

Vectura Signs Agreement with Incannex to Advance TBI Treatment

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

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.

Subunit Vaccines and the Fight Against COVID-19

CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis. 

CureVac Releases Interim Results from COVID-19 Vaccine Candidate Trial

Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

PHE Analysis Demonstrates Efficacy of COVID Vaccines Against Delta Variant

Sanofi’s new Pennsylvania facility expands production of Fluzone High-Dose Quadrivalent flu vaccine.

Sanofi Facility for Flu Vaccine Licensed by FDA

Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.

Novavax Reports on Two Vaccine Efficacy Studies

CPI has revealed an agreement with DFE Pharma, making it the latest partner of the Medicines Manufacturing Innovation Centre (MMIC) collaboration.

DFE Pharma Becomes Newest Partner in MMIC Collaboration

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

Dosage Forms

Assessing Risk and Production of Potent Substances

Using QbD to Develop Fixed-Dose Combination Tablets

The Art and Science of Topical Drug Formulation