Process and Scaling

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.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.

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.

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

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.

This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

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.

Experts discuss the key considerations in the development of an autoinjector.

This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.

PharmTech sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.

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

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

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.

Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.

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.