Pharmaceutical Technology, July 2021 Issue

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.

The future pipeline of complex novel biotherapeutics will require new approaches to analytical assessment.

The purpose of this research was to formulate modified liquisolid compacts (MLSC) of RLX for improved dissolution in immediate-release tablet formulations.

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.

Bi-layer tablets are an under-utilized option that can be employed to help reduce treatment burden, but their formulation is more complex than for conventional monolayer products.

Particle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.

Container and equipment innovations expand applications.

Despite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.

A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.

The draft revisions of Annex 1 are driven by a quality risk management approach and will provide more clarity and detail for manufacturers.

CMOs and CDMOs adjust business processes as demand for COVID-19 treatments and non-pandemic related therapies puts pressure on the bio/pharma industry.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

Vaccines define the path to putting the pandemic in the rear-view mirror.

Five therapeutic candidates for the treatment of COVID-19 are identified as promising by the European Commission.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

Die table segment cleaning equipment features a fixture that holds the segment within the tank and leaves the bores unobstructed.

The Lasair Pro Airborne Particle Counter from Particle Measuring Systems is designed to meet data Integrity and regulatory requirements.

The 3M Harvest RC clarifier condenses three process steps into a single-stage purification of recombinant protein therapeutics.

ROSS’ Sanitary Ribbon Blenders allow operators to safely empty bags of powder through a bar grating while a contiguous vibrating tray assembly catches debris and off-spec ingredients.