Formulation and Drug Delivery, Biologic Drugs

AAV and lentivirus both have pros and cons in their use for specific gene therapy applications.

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

Swiss CDMO CordenPharma and Spain-based Certest will collaborate on the development of ionizable lipids for LNP formulations.

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

This article represents a comprehensive exploration about biopharmaceutical excipients, exploring their multifaceted classification, active role in drug formulation processes, inherent challenges, and upcoming advancements poised to revolutionize the drug formulation and its efficacy for patient welfare.

Despite slow growth over recent years, the CAR-T cell therapy space is expected to see considerable advancements in the near future.

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

Nanoparticles offer the potential for a safer, more effective method of drug delivery to the patient.

There are solutions on the horizon that will help overcome the current bottlenecks and other challenges that are occurring in early drug development.

The integration of the binders into a routine lateral flow test will support the clinical and commercial development of rapid diagnostics for Alzheimer’s disease through nasal sampling.

Outsourcing collaborations provide insight into the key drivers of market growth.

FDA’s Division of Applied Regulatory Science’s (DARS) computational toxicology and pharmacology research has been focused on the development of highly curated data sets and QSAR models for endpoints of regulatory interest.

Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.

The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.

This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.

There are many benefits of employing a reformulation strategy, but companies must also overcome a variety of challenges too.

Manufacturing and processing challenges surrounding mRNA can be overcome in order to realize the true potential of a technology 30 years in the making.

While a variety of innovations have already impacted the drug delivery landscape, improving sustainability and having the ability to make smaller volumes of drug products still require work.

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

Novo Nordisk will expand its existing research collaboration in novel delivery technologies with MIT and Brigham and Women’s Hospital.

The agreement expands Pfizer’s access to LNP formulation technology for mRNA vaccines and therapeutics.

Fujifilm’s center adds local support in Suzhou, China for cell culture media optimization.

Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.

Eli Lilly and Company has partnered with leading diabetes tech firms to offer app compatibility with insulin smart pens to streamline diabetes management with automated data collection.

Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.

The inhaled route of administration for biologics is experiencing renewed interest, particularly in light of the COVID-19 pandemic.

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines.