Formulation and Drug Delivery

This Behind the Headlines news roundup panel discussion on recent news items includes updates regarding sickle cell therapies (e.g,, Pfizer’s withdrawal of Oxbryta and Vertex’s choosing of Lonza as the commercial manufacturer of Casgevy); Emergent BioSolutions $400 million BARDA contract for an mpox vaccine; and the first in a generation novel schizophrenia drug, Cobenfy (xanomeline and trospium chloride). The panel also examines investment revival with ARCH Ventures $3 billion biotech fund raise and the $3.6 billion for Flagship Pioneering. Rounding things out is a discussion on COVID-19-associated childhood myopia and patent thickets artificially keep the price of drugs high.

Pharmaceutical Technology sat down with Erica Schlesinger, vice president of technical development at Serán Bioscience, to talk about her upcoming presentation at AAPS PharmSci 360 2024, “High Dose Subcutaneous Delivery of Protein Therapeutics.”

The best strategy is to use a combination of complementary methods.

Solving the challenge of better-stabilized temperature-sensitive biomolecules hinges on innovative formulation strategies.

A new Center of Excellence will be established at PCI Pharma Services’ location in Rockford, Ill., and two sites in Ireland will also benefit from the investment.

FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.

The agency is recommending the extension of the smallpox and mpox vaccine, Imvanex, to adolescents aged 12 to 17.

Excipient and delivery device selection play crucial roles in the formulation of inhaled drugs.

New and existing technologies, as well as a patient-centric focus, are pushing drug formulation into exciting directions.

Vectura’s expertise in the field includes formulation and device development for dry powder inhalers and pressurized metered dose inhalers, among other products and services.

The company said this new commitment to its facility in Germany goes hand in hand with its recently announced ReciPredict, an initiative intended to streamline the product development cycle.

Insights into molecular behaviors and predictive capabilities are bringing numerous benefits.

A coordinated and international response is needed to help control the latest mpox outbreak in Africa.

For a preview of what's to come at the AAPS PharmSci 360 show in October, Pharmaceutical Technology® spoke with Vivek Gupta, PhD, associate dean for Graduate Education and Research, associate professor, Pharmaceutical Sciences, St. John’s University, Queens, New York, about the formulation of inhalation dosage forms.

Employing novel technologies and more patient-centric approaches can help to reduce the potential of formulation failure.

Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.

A holistic approach to automation can provide benefits at all stages of development and manufacturing.

STADA and Alvotech have launched Uzpruvo in Europe, making it the first approved biosimilar to Stelara (ustekinumab) in the European market.

Pelletization, a popular oral drug delivery method in pharmaceuticals and nutraceuticals, offers numerous benefits. This article delves into the critical parameters for formulation development and technological consideration in pelletization, elucidating its significance in advancing pharmaceutical solutions.

Weighing development costs/resources and performance benefits is essential.

Roche voluntarily recalled Susvimo’s ocular implant, insertion tool, and initial fill kit when test results did not satisfy company standards.

The companies have restructured their existing collaboration into a licensing agreement that invests in mRNA development.

A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.

The company is referring to its search for innovative approaches as crowdsourcing and will award at least one cash prize.

At BIO 2024 in San Diego, John Dunlop, PhD, chief scientific officer at Aliada Therapeutics, sat down for an interview with Pharmaceutical Technology to discuss the firm’s MODEL platform and its potential impact on therapeutic delivery for brain-related conditions.

CordenPharma has partnered with Spain-based Certest to develop ionizable lipids for LNP formulations.

A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.

Artificial intelligence and machine learning can help overcome poor solubility and bioavailability.

The final drug product relies on the quality and reliability of the raw materials used in its production.

Biosimilar analytical assessments focus on demonstrating biosimilarity and interchangeability with the reference biologic.