Formulation and Drug Delivery

Further advances in construct design and manufacturing scalability are still needed.

The option of using prefilled syringes for vaccinations is not (yet) available for all types of vaccines. Stakeholders are working to expand that option while also pursuing other non-traditional routes of administration.

In this episode, Fernando Muzzio provides greater insight into a novel approach to improving drug solubility—continuous melt coating.

Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.

Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.

Biosimilar data analysis must demonstrate a correlation between structure and function.

Technological advances are progressing pharmaceutical packaging to overcome the challenges of the future.

Biologics are forming a greater proportion of the development pipeline, but there are still some formulation difficulties to overcome to ensure clinical and commercial success.

Lack of toxicity data and poor physicochemical properties must be overcome.

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.

The expansion at Seqirus’ Holly Springs, N.C., manufacturing facility will support the formulation and fill/finish of influenza vaccines.

FDA has approved GSK’s vaccine for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.

Putting the patient at the forefront of drug development is essential, particularly to ensure medication compliance is optimized.

The right processes used with the right excipient combinations address evolving formulation needs.

The inaugural Connect in Pharma event will take place on 14 and 15 September in Geneva, Switzerland.

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.

The latest manufacturing technologies are essential for helping pharmaceutical formulators meet up-and-coming trends in OSD treatments.

The need for sustainability and early considerations of a lyophilization strategy grow more pertinent on the back of growing biologics volume.

CGTs offer hope for the future of treatments, but the costly manufacturing, slow turnaround time, and need for supplies hinder progress.

The author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.