Drug Development

The performance of nanoparticles used as carriers in drug delivery is intimately linked to their physical properties. Nanoprecipitation is a common method for the preparation of drug-loaded polymer nanoparticles, but until recently, the reproducibility of the two primary dimensional descriptors-the average particle size and the breadth of the size distribution-has been a challenge due to the intrinsic variability of batch processes. Microfluidics-based flow techniques, however, reduce variation in drug-loaded polymer nanoparticle synthesis.

Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.

The author discusses the advantages of high-throughput screening of drug formulation excipients by a fully automated Tecan-robotic system.

Integration of formulation development, real-time adaptive GMP manufacturing, and clinical testing using a consumer preference panel can save time and cost in performing taste-masking assessments.

Can an Irish analytics company and its CEO bring pharma closer to 21st-century practice?

A jury verdict requiring Gilead Sciences to pay $2.54 billion for patent infringement to competitor Merck & Co. over Gilead's Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir), two best-selling hepatitis C drugs, has been overturned.

PharmaMar has released the results of MI130004, a novel antibody drug conjucate created using a molecule of marine origin.

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.

The research partnership will focus on advancing regenerative medicine using porcine bioproducts.

A new suite for the encapsulation of highly potent drugs will be added.

The study suggests that circumventing evolution in cell factories can enable the commercialization of new biobased chemicals to large-scale.

Colorcon's Opadry EZ provides superior slip and significantly reduces the probability of the tablet sticking to the throat or esophagus.

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

A new report states that more research and clinical development must be done in the treatment of pain and addiction.

The acquisition strengthens an already existing collaboration between the companies to advance clinical development of therapies across multiple drug categories.

The Awards honor innovations in drug delivery and packaging, for better patient safety and compliance.

Through its Janssen pharmaceutical companies, Johnson & Johnson, has partnered with Theravance to develop and commercialize a therapeutic for inflammatory bowel diseases.

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.

Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.

Mark Egerton, PhD, chief executive officer of Quotient Sciences, shares insights on a new approach to accelerate drug development, which integrates formulation development, real-time adaptive GMP manufacturing, and clinical research within a single platform.

Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer, which include: strong relationship between the customer, the contract development and manufacturing organization, and other partners based on deep knowledge in the technology; established and proven quality-by-design processes; risk mitigation management; project leadership; flawless execution; and mutual trust.

A collaboration between The Centre for Process Innovation and The Roslin Institute aims to develop commercially viable and scalable methods of producing biologics using transgenic animals.