Manufacturing

Different approaches for qualification of personnel for visual inspection of residues on equipment surfaces are reviewed.

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

Kurt Lumden, Director, Client services at PAREXEL's Perceptive Informatics, discusses the management of investigational product temperature excursions.

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.

CMC Biologics and OnoSynergy form an agreement from cell-line development.

Pfizer appoints management changes to take effect in 2014.

Cyclonic-spray technology improves spray consistency and allows mixing at the point of delivery.

Buying and selling used laboratory and process equipment has become mainstream; experts offer tips to potential buyers.

A bottom-outlet valve with combined sensor is a new process analytical technology tool.

USP is developing and revising distribution standards in response to changes in the global supply chain.

Operator training, preventive maintenance, and regularly scheduled calibration help prevent the manufacture of off-weight tablets.

FDA and EMA launch initiative to share bioequivalence inspection information.

Agency issues precautionary recall due to manufacturing fault.

Agency issues precautionary recall due to manufacturing fault.

BioWa and Lonza have entered into a licensing agreement with MedImmune for cell line technology.

Industry experts discuss challenges in managing the cold chain.

Standards for ferrules and cap overseals focus on explicit warnings.

FDA cites cGMP violations and data-integrity issues and raises concerns over the company's ability to implement a robust and sustainable quality system.

Alvotech plans investment in biosimilars portfolio and manufacturing facility.

The flexible biomanufacturing system uses single-use technology.

Facility in Germany provides space for evaluating continuous pharmaceutical processing equipment.

Excipients for lowering formulation costs and improving lipid-based formulations and the use of melt-spray-congeal microsphere sachet technology for targeted controlled release attract attention at the 2013 American Association of Pharmaceutical Scientists Annual Meeting.

Rail-Mounted Fluid Bed Dryers Allow Cleaning Access

Siegfried Schmitt, principal consultant at PAREXEL, discusses the state of drug manufacturing in India.