Formulation and Drug Delivery

In light of the hype around chloroquine and hydroxychloroquine as potential COVID-19 treatments, it is important to remember that drug repurposing should never be rushed, irrespective of the urgency of the situation.

Equipment and process optimization must be considered for scaling up these developmental technologies to commercial production.

Many antibody-drug conjugate therapies are in the pipeline; however, only a handful have been approved. What are the bottlenecks?

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.

Reformulation strategies can provide drug developers with a head start to achieve promising options that benefit the patient.

The goal of the collaboration is to manufacture up to one billion does per year of mRNA-1273, Moderna’s vaccine against the novel coronavirus.

AstraZeneca and the University of Oxford have announced that they will collaborate on the global development and distribution of the university’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection.

Merck will provide funding and will work with researchers at the Institute for Systems Biology to identify targets for therapeutic intervention and vaccine development.

A UK BioIndustry Association industry-led vaccine manufacturing group has welcomed a recent announcement by the government of the UK, that it will receive £14 million (US$17.3 million) in investment to rapidly scale up the development of vaccines for COVID-19.

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

The vaccine will be based on a ReiThera-proprietary simian adenoviral vector with strong immunological potency and low pre-existing immunity in humans.

Emergent will offer up its drug substance manufacturing services with support by investments from Johnson & Johnson starting in 2020.

Through the agreement, BARDA will support the advancement of the vaccine candidate to FDA licensure and will handle all late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020.

Dutch company HALIX has announced it is joining a consortium of partners that are all under the guidance of the University of Oxford to provide good manufacturing practice (GMP) manufacturing services for a COVID-19 vaccine.

This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.

Sanofi and GlaxoSmithKline (GSK) have revealed that they are joining forces to develop an adjuvanted vaccine using their respective technologies that can be used to fight COVID-19.

With the acquisition, Orgenesis will combine TamirBio’s ranpirnase antiviral platform with its Bioxome technology.

The partners have formed a joint venture to produce muscle-derived mesenchymal stem cells as a source of exosomes and other cellular products to develop related therapies and advance clinical trials.

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.

A quick look at the history of OTC dosage form development shows the importance of patient-centered innovation.

Mannitol has been shown to improve patient perceptions of tablet flavor and mouthfeel, but its use can add to tableting challenges. SPI Pharma has developed new grades of material designed to make it easier to manufacture in patient-centered formulations.

FDA is encouraging alternative insulins and challenging anticompetitive practices.

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.