Pharmaceutical Technology-08-02-2020

The COVID-19 pandemic has raised several questions about the safety of the pharmaceutical materials supply chain. Is onshoring the answer?

Pharmaceutical Technology spoke with Matthew Woodcock, director of LLamasoft, a supply chain analytics company that assists companies in their decision-making and supply chain challenges, about the impact the COVID-19 pandemic has had on the pharmaceutical supply chain.

This study suggests that using a simple centrifugal method can produce a natural polymer-blend molecule that can successfully be used as an oral delivery mechanism for poorly soluble drugs.

Particle engineering is a useful tool to manipulate API particles into a form that is manufacturable and deliverable to the patient.

Understanding and overcoming excipient variation are crucial for successful continuous processes.

Even though many companies are at early stages of digital automation, more are evaluating BioPharma 4.0 tools and leveraging built-in automation to speed scale-up and boost efficiency.

Regulatory, analytical, and process concerns must be taken into account.

A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.

Dissolution testing is an important aspect of drug development as it provides stability parameters and helps predict drug behavior in-vivo.

COVID-19 has brought to light the issues of European manufacturing capabilities, leading industry to question whether it is now time to reinvest in domestic medicines supply.

Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.

Conversations with CMOs/CDMOs about capabilities and how they work to reduce complexities in the supply chain should focus on cost efficiency, temperature excursions, and sustainability.

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

EU regulators are requesting more effective action be taken to tackle serious impurities in APIs and finished products.

Time sure flies, except when you are waiting for something to happen.

COVID-19’s impact on the global economy is dealing a blow to merger and acquisition activity in the biopharma industry.

When in-person training may not be feasible, there are still opportunities to ensure employees receive the required training, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

Aclar Edge from Honeywell is a pharmaceutical packaging solution for oral liquids for human health and sterile injectables for animal health applications.

The Certa Plus pump series from Watson-Marlow Fluid Technology Group works to provide sustainable fluid management while offering lower shear, lower power consumption, full traceability, and ultimate cleanability when transferring syrups, oils, creams, and gels.

Advanced Discharge Systems by Ross are built with mechanisms to fit almost any high-viscosity application and increase efficiency following the mixing process.

Korsch introduced the XT 600 HD Double Rotary Tablet Press, a tablet press intended for technical and chemical products with large formats, deeper filling depths, and higher compression forces.