APIs and Excipients

All members of the pharmaceutical supply chain must implement reliable sourcing and manufacturing strategies that balance quality and costs to ensure the uninterrupted supply of high-quality medicines to patients worldwide.

Twin-screw granulation process insight is growing as researchers employ new analytical technologies and investigate new ways to use the equipment.

Sample dilution, sensitivity, excipient interference, and containment are key issues that must be addressed.

Aenova has opened a new building for the production of highly potent APIs in Germany.

Nanotech-based delivery technologies are receiving significant attention.

Process control is essential for using continuous hot-melt extrusion to enhance solubility.

Despite the advantages intensified processes can offer developers, there are still some obstacles to overcome before broader application of new technologies will be implemented.

Curia is collaborating with Corning to advance biopharmaceutical continuous-flow development and manufacturing programs.

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.

Numerous benefits will eventually lead to large-scale applications in pharmaceutical manufacturing.

Roquette’s acquisition of Crest Cellulose is designed to reinforce its presence in India and other countries in Asia.

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality.

Pharmaceutical Technology spoke with Niamh Lynch, Executive Director, Global Head of Quality, Lonza Small Molecules, Basel about best practices for API quality and the impact of the nitrosamine contamination situation.

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.

Pharmaceutical Technology Europe spoke with representatives from the European Directorate for the Quality of Medicines & Healthcare (EDQM) about API quality from their perspective.

Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective.

Lack of toxicity data and poor physicochemical properties must be overcome.

The right processes used with the right excipient combinations address evolving formulation needs.

Lubrizol has launched Apisolex technology to improve solubility and simplify the manufacturing of parenteral drug products.

New report released by USP offers a look into API supply-chain vulnerabilities.

ImmunoGen and Eli Lilly and Company have entered into an agreement that gives Lilly exclusive rights to research, develop, and commercialize ADCs designed for targets selected by Lilly from ImmunoGen’s camptothecin technology.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

Increased patient-centricity and alternative dosage forms require careful consideration when selecting the best taste-masking approach.

Polymeric amorphous solid dispersions are the most commonly used technology, but amorphous APIs remain inherently unstable.

Navigating a complex global regulatory landscape involves upfront research into the expectations of the different regulatory bodies, thorough documentation of every step of the API manufacturing process, and good communication.

Drug makers are going beyond continuous improvement and green chemistry to increase the sustainability of small-molecule manufacturing.

Consistency, robustness, and understanding of the API and controlled-release excipients are essential for successful drug dosing.

Data sharing facilitates traceability, transparency, and accuracy while driving efficiencies and boosting quality of active pharmaceutical ingredients.