Process Development

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.

Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.

Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.

FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

Process analytical technology, based on monitoring particle size distribution and tracking coating thickness measurements in real time, can be used to predict the dissolution of polymer-coated multiparticulates.

Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.

Soft sensors are powerful tools that can be used along with spectroscopic instruments in on-line measurement.

GEA’s ConsiGma continuous tableting line combined with Siemens’ automation and Sipat data management systems enables continuous manufacturing.

As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.

FDA and BARDA awarded a contract to Continuus Pharmaceuticals to develop an end-to-end continuous manufacturing process for solid-dosage drugs.

Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.

Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.

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.

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

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.

The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties. \

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

Industry experts discuss the benefits and challenges of using single-use systems in pharmaceutical manufacturing.

A US government report on advanced manufacturing promotes continuous manufacturing of pharmaceuticals, which has had recent commercial success but faces challenges for widespread adoption.

FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.

FDA approved an update in the manufacturing of Prezista (darunavir) using a continuous manufacturing line at Janssen Supply Chain’s facility in Puerto Rico.

Transferring the manufacturing of a drug from one scale to another or between manufacturing sites presents both technical and business challenges.

Pharmaceutical Technology spoke with Bill Randolph, vice-president, Technical Services, Janssen Supply Chain, about some of the considerations for technology transfer of a continuous, solid-dosage manufacturing process and what he sees as the outlook for continuous manufacturing.

A team of Bristol-Myers Squibb scientists will work in a new laboratory at the National Institute of Bioprocessing Research and Training facility in Dublin, Ireland.

The author discusses key process parameters and shows how a process optimization template can be used to improve this key operation.

The author discusses issues and best approaches for solid dosage form pharmaceuticals.

This article explores two commercial platforms, and touches on a new program underway in the UK.