Drug Development

he guidance addresses the good manufacturing practice for managing quality in APIs.

This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.

The editors seek drug development experts to contribute technical articles for 2017.

Excipients play a crucial role in the manufacturing of solid-dosage forms and the performance of the finished drug product.

Researchers develop catalysts that mediate complex transformations under conditions appropriate for commercial manufacture.

Understanding the components of a reference marketed pMDI is needed to develop a generic pMDI.

Tapemark, a full-service CDMO specializing in transdermal, oral thin film, and topical drug-delivery technologies, is exhibiting at CPhI.

Three-dimensional (3D) printing, which is a type of additive manufacturing (AM), enables fabrication of specialty drugs and medical devices, said Emil Ciurczak, Doramaxx Consulting and CPhI expert panel member, in the 2016 CPhI Annual Industry Report.

The current approach of classifying process parameters and quality attributes as critical or non-critical is too simplistic to adequately reflect current science and risk-based approaches to product quality.

BASF’s new production facility in Shanghai will produce PVP K30 powder, a polymer used as a base for pharma excipients.

West will showcase several drug-delivery systems and packaging component technologies such as its NovaPure plungers and SmartDose technology platform.

Dow and Colorcon extend and broaden the scope of the Controlled Release Alliance.

Clinical biotechnology company Moderna Therapeutics will build an integrated clinical manufacturing facility for mRNA production in Norwood, Massachusetts.

The certification follows a successful inspection by the MHRA, with no critical or major observations. The site is now ready to start production.

The Novelia system has been approved as a packaging component and delivery system of multidose drug product formulated without preservatives.

Saneca Pharma is making significant investment in its API capabilities to support client demand for smaller batch sizes and streamlined scale-up.

Following the United Kingdom’s decision to leave the European Union, there are two areas that demand attention-clinical trials and marketing authorization

Regulatory agencies meet to discuss approaches to the development of antibacterial agents.

Nanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.

Researchers at GlaxoSmithKline report a greener and lower-cost route to chiral fluorolactams that is suitable for scale up.

Aptar Pharma has signed a license agreement with BD to jointly develop and bring a new autoinjector to market.

Flexible batch sizes for semi-continuous unit operations, such as tableting and encapsulation, can improve efficiency while maintaining quality.

Sound process understanding and having effective controls in place are crucial in ensuring that consistent product quality is obtained during API manufacturing.

IPEC consultant Irwin Silverstein discusses third-party audits and regulatory compliance issues facing suppliers and their customers.

Analytics and science-based approaches are shedding more light on these complex dosage forms, promising to improve process control and product design.

The platform combines an expression system with equipment and process controls to enable rapid development and scale-up of robust titers.

API and drug product manufacturer changes name to align with parent company.

Dalton Pharma Services completed an expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

Researchers at the Massachusetts Eye and Ear Infirmary developed a potential drug delivery method using a contact lens to deliver glaucoma medication.

The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.