Dosage Forms

A core coating module allows Roeltgen's FlexiTab development and small-batch tablet press to manufacture multi-layer and externally lubricated tablets.

The Ph. Eur. contemplates adding specifications for sub-visible particles in eye drops and eye lotions to its monograph.

Recipharm makes a strategic investment in Synthonics and partners in development of novel compounds.

Innovations include multimedia packaging and improved filling systems.

The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.

Bosch Packaging Technology's RAN 3080 exterior washing machine removes product residue and other contamination from filled and closed glass containers using a new, efficient, high-pressure cleaning process.

Innovations for tablet tooling and presses improve quality and productivity.

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

Industry awaits the final revision of USP General Chapter and the impact it will have on the evaluation of sterile product package integrity.

Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.

Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.

In-silico design facilitates process optimization and evaluation of process control strategies.

NIH announced positive safety results from the vaccine, VSV-ZEBOV, and found that all patients in the study experienced a strong antibody response.

The Human Microbiome Project has increased our understanding of the relationship between humans and microorganisms. The authors offer a new perspective on how this knowledge should be considered in setting standards for pharmaceutical quality control in microbiology.

A drug-product manufacturing classification system (MCS) for oral solid-dosage forms is proposed by an Academy of Pharmaceutical Sciences working group.

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

FDA approves a biosimilar and loses a commissioner in March.

Multivariate data analysis (MVDA) is being used to effectively handle complex datasets generated by process analytical technology (PAT) in biopharmaceutical process development and manufacturing.

Merck Serono announces that it will work with Intrexon to develop a cancer therapy using chimeric antigen receptor T-cells.

Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.

Drug makers back alternative to FDA labeling update rule.

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

A new machine is designed for inspection of prefilled syringes.

Member of parliament, Desmond Swayne, will officially open the 42,000-square-foot facility on March 20, 2015.

WuXi's new facility in Philadelphia will manufacture CAR T-cell therapies and other cancer immunotherapies.