Pharmaceutical Technology-01-02-2021

Biopharma looks to deliver on COVID-19 vaccines and other promising therapies.

Despite the COVID-19 pandemic disruptions, with continued support and industry resilience, the European bio/pharma outlook for 2021 is positive.

Essential bio/pharma employees show hard work and dedication can pay off for patients.

Demand for specific advanced laboratory skills drives creates a positive employment market.

To restrict the use of intentionally added microplastics, the European Chemicals Agency has proposed a restriction dossier that describes various measures aimed at minimizing the use of microplastics in various industrial segments, including pharmaceuticals. In this paper, the authors discuss these restrictions.

FDA approval rate speeds up despite COVID-19 complications.

The right partner can help companies overcome key formulation challenges for biologic drugs.

Consider a matrix of factors when choosing what type of cleanroom facility to construct.

As the first wave of mRNA vaccines are distributed, efforts will be needed to protect data and prevent errors.

During the COVID-19 pandemic, when inspectors cannot visit sites directly, FDA is relying on other global inspection reports and remote document review, yet does not consider them equivalent to on-site inspections. Manufacturers await more clarity.

Positive regulatory developments are aiding the growth of the cannabis pharmaceuticals market, but more clinical data are needed to break the stigma and bring science to the fore.

EMA’s SPOR implementation guide version two is expected to be published soon, starting the countdown for companies to ensure their data-based submissions are compliant.

Traditional biologic-based testing methods may need an upgrade to properly test newer therapeutic modalities.

Outsourcing increases as the industry balances development and manufacturing of both COVID-19 treatments and non-pandemic-related medicines.

The incoming administration faces key decisions on drug testing and access as well as vaccine distribution challenges.

The recently published European pharmaceutical strategy is being seen as an opportunity to strengthen medicines regulation in the region.

The outlook for the European pharma industry is appearing to be favourable overall.

Shutting down the COVID-19 pandemic requires a global, selfless effort.

Updating the quality technical agreement will clarify any expectations and limitations, says Siegfried Schmitt, vice president, Technical at Parexel.

GEMÜ’s process solenoid valve with pressure compensation, the GEMÜ M75, uses a double bellows principle to balance pressure forces, which allows the valve to be used for processes with an operating pressure of up to 6 bar.

Boreas from Telstar are -86 ºC ultra-low-temperature freezers developed to house COVID-19 vaccines.

The new Sanitary Rotary Batch Mini Mixer from Munson Machinery Company has the ability to de-agglomerate and blend up to 5 ft3 (142 ℓ) of dry bulk ingredients with or without liquid additions at several locations.

ROSS’ Sanitary Ribbon Blenders with ergonomic material handling accessories feature a new design that allows operators to safely empty bags of powder through a bar grating while an adjacent vibrating tray assembly catches debris and off-spec ingredients.

The number of recommendations for European marketing authorization of human medicines saw significant increase in 2020 over the previous year.