Manufacturing, Solid Dosage Drugs

CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization.

Establishing OEL data and ensuring appropriate engineering controls are crucial aspects of safe handling.

At-line NIR measurements can replace a laboratory HPLC measurement for API content in oral solid-dosage drug manufacturing.

In this interview, the main uses and benefits of NIR spectroscopy in tableting are discussed.

Early adopters of continuous manufacturing approaches shared their plans and some of their experiences at the 11th annual Charles Jarowski Symposium in Industrial Pharmacy.

Homogeneity of the powder blend is crucial for solid-dosage drug manufacturing.

Lonza plans to implement MES software to accelerate paperless, 24/7 production of drug capsules.

The expansion of Lonza’s Tampa site includes development and manufacturing capabilities for oral solid-dose drugs.

A presentation at the Leistritz Pharmaceutical-Nutraceutical Extrusion Seminar explained how simulation tools benefit the development process.

StarTab from Colorcon was designed to ensure functionality and stability for direct compression tableting.

The UK’s Centre for Process Innovation is collaborating with partners GSK and AstraZeneca to establish a continuous wet granulation manufacturing facility for small-scale development of oral solid-dosage pharmaceuticals.

Educational sessions on the INTERPHEX show floor will include a panel discussion on implementing continuous manufacturing.

3D printing offers a new design freedom for bio/pharmaceutical manufacturing: whether for “printing” a solid-dosage drug or for creating a piece of equipment for bio/pharmaceutical laboratories or manufacturing facilities.

In OSD continuous manufacturing, flexible batch sizes can optimize supply, but equipment and processing challenges are still being addressed.

When specifying an automated powder transfer system for vacuum conveying of pharmaceutical powders, consider material properties, facility constraints, and designs to mitigate explosion.

Sticking and picking are common problems in tablet manufacturing. Considering tablet compression issues before tablet designs are finalized can prevent unanticipated problems during scale-up and full-scale production.

Flexibility and well considered manufacturing approaches could help tablet manufacturers face the increasing pressure resulting from the shifting bio/pharma development landscape.

Market demand and regulatory guidance continues to promote improved medication design.

Serialization-ready packing equipment and services to manage data assist companies with DSCSA compliance.

Catalent announces investment for its Zydis ODT technology, offering increased drug load and taste-masking capabilities.

FDA guidance on quality considerations for continuous manufacturing should help advance implementation by providing clarity and giving companies more confidence to make investments in the new technology.

Containment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.

Tornado Spectral Systems, winner of the 2018 CPhI Excellence in Pharma Award for Analysis, Testing, and Quality Control, discusses real-time process measurement for biopharmaceutical and small-molecule drug manufacturing.

Boehringer Ingelheim plans to develop and test new strategies at its Solids Launch facility.

This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.

The company’s planned investment in its alkoxylation facility in the United States Gulf Coast will also expand production capacity for its polyethylene glycols.

At CPhI Worldwide 2018, Tom Wilson, vice president of Contract Manufacturing Operations for Pfizer Global Supply and Pfizer CentreOne Contract Manufacturing, will discuss best practices for meeting manufacturing challenges of compliance as requirements shift.

Innovative technologies, such as drug-loaded devices and 3D printing, enable advances in implantable devices and other novel dosage forms.

Barrier materials, scavengers, and good seal integrity maximize shelf-life of oral solid-dosage drug packaging.

A twin-screw extruder can be used as a continuous wet granulator.