Pharmaceutical Technology-05-02-2021

Complex formulations, personalized medicines, COVID-19 therapies, and sustainability goals are driving innovations in drug packaging.

This article introduces a practical approach to determining the best estimate for probability of passing uniformity of dosage units (content uniformity) using probability vs. lot coverage charts and tables constructed using simulated probability and lot coverage (LC1) data.

Applying a QbD approach helps address excipient variability and other quality features.

Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.

Aprecia and Glatt investigate manufacturing technologies to widen the formulation design space for oral delivery.

Breakthroughs in analytics and alternatives to traditional freeze drying promise to reshape biological development and the cold chain.

Despite the COVID-19 pandemic, the industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.

Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies.

Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

As face masks start to come off, bio/pharma’s COVID-19 battle goes on.

The world of bio/pharma has been celebrating its achievements across a variety of categories in the latest rounds of awards.

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.

Aber Instruments launched its new Futura neotf single-use biomass sensor for process fingerprinting for on-line monitoring and control of cell culture.

The XPR Automatic Balance by Mettler Toledo works to reduce exposure risk and ensure precision and throughput while powder weighing in laboratories.

Inline High Shear Mixers from ROSS are suitable for a wide range of dispersion, emulsification, and homogenization requirements

Munson Machinery introduced a new Bag Dump Module for installation on the lids of bulk solid mixers, blenders, size-reduction equipment, and storage vessels to maintain the dust produced when bulk materials are dumped manually.