Dosage Forms

The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.

According to results from the FOURIER trial, Repatha significantly reduced the risk of cardiovascular events and death in patients with atherosclerotic cardiovascular disease.

Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.

Alexandre Juillerat, PhD, innovation senior scientist at Cellectis, discusses novel construct UCART123, an investigational agent that is on deck to be the first gene-edited T-cell product in the United States.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

ADMA will acquire BPC’s plasma-based fractionation and purification plant in Boca Raton, FL and plans to resolve issues at the facility noted in an FDA warning letter.

SGS invested in test equipment for analyzing extractables and leachables at its New Jersey laboratory.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

Researchers from Cellectis investigate how external signals in the tumor microenvironment could control the cell-surface expression and specificity of engineered CARs.

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

Camfil Air Pollution Control has expanded its testing laboratory and added a dust collection test rig for the ANSI dust collection standard.

EAG Laboratories offers dermal absorption studies using OECD methods.

Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.

An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.

The membrane-based Protein A purification tool was unveiled at the 2017 PepTalk Conference in San Diego, California.

Language surrounding regenerative medicine and the REGROW Act appeared back into the 21st Century Cures Act right before it passed. What will this mean for the controversial testing and marketing of stem-cell therapies?

The companies will combine expertise on T-cell therapies with two or more binding domains to create novel oncology medications.

The partnership will focus on providing practical information to clients on the development of biologics and vaccines.

GEA’s ConsiGma continuous tableting line combined with Siemens’ automation and Sipat data management systems enables continuous manufacturing.

Catalent announces a development agreement with JOT to evaluate softgel options for a resveratrol drug candidate.

Moisture uptake during the end-to-end manufacturing process and supply chain can affect product quality. Simulation tools based on mechanistic models help define storage and handling requirements for oral solid-dosage drugs.

Advances in materials and equipment for pharmaceutical blister packaging protect quality and enhance shelf life.

FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.

A pilot project, beginning in 2017, will support the development of biosimilars.

Univercells received a grant from the Bill & Melinda Gates Foundation for the development of a vaccine manufacturing platform.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.