Manufacturing

Ribbon Blender Model 42N-270 Increases Performance

ALpHA G Capsule Filter for Single-Use Systems

Training, calibration, and preventive maintenance help prevent over-and under-weight tablets. The author discusses causes of off-weight tablets and best practices for tableting.

Gericke N200 Nibbler Provides Size Reduction

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.