Pharmaceutical Technology-03-02-2021

In a pandemic, genetic vaccines offer several advantages over traditional approaches.

The epilepsy treatment, Potiga, has been used off-label to treat specific types of epilepsy in some children. However, it has never been formally evaluated in pediatric clinical trials. Using a modified QbD approach, the authors have developed a granular formulation suitable for use in clinical trials involving infants and children.

Without an independent approval pathway for novel excipients, true pharmaceutical innovation could be stymied.

Various strategies to improve bioavailability are being continuously evaluated, affording greater commercial prospects for the future.

Integrated, paperless data systems can improve efficiency and quality.

The need for real-time monitoring and control has spurred the development of new analytical tools.

Pharmaceutical laboratories must work to maintain lab data integrity practices as the pandemic surges on and cybersecurity risks increase.

The COVID-19 pandemic is pushing more companies to adopt just-in-time practices, but success demands careful upfront risk assessment and planning.

Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.

The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.

Bio/pharma works hard today to change the calendar to tomorrow.

More work is needed to ensure the rising demand for cell and gene therapy manufacturing capacity and required skilled workforce can be met in Europe.

Auditing distribution suppliers provides understanding and documentation of the services performed, says Siegfried Schmitt, vice president, Technical at Parexel.

Nova Biomedical added a Sample Retain Collector (SRC) to its FLEX2 cell culture analyzer, which works to measure up to 16 tests including pH, gases, metabolites, osmolality, cell density, and cell viability.

Particle Measuring Systems introduced the MiniCapt Mobile Microbial Air Sampler, a monitoring instrument designed to prevent the introduction of bacterial contamination created during monitoring activities.

The 3M Polisher ST from 3M Health Care is a single-use anion exchange (AEX) chromatography solution intended to replace the reusable AEX polishing column for biologic drug manufacturing.

Inline high shear mixers from ROSS are available from 1 through 250 HP to accelerate mixing, emulsification, and homogenization in recirculation and continuous modes.