Formulation and Drug Delivery

The Natoli AIM Data Acquisition and Analytical Software for Natoli’s NP-RD10A single-station tablet press speeds research and development.

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.

The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.

Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.

Assessing potential formulation and manufacturing issues in early development phases can improve a drug’s chances for success.

Drug companies must consider all factors impacting the cost of drugs, including high costs of early development stages.

Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.

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 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.

Fluarix Tetra has been approved for use in children aged six months and above.

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

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

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

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.

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.

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.

Cambrex invests in development and laboratory facilities and adds staff.