Pharmaceutical Technology Editors

ROSS incorporated a high shear rotor/ stator into its Dual-Shaft Mixer to meet more intense shearing and homogenization requirements. 

Rather than including a typical high-speed disperser blade, the mixer comes equipped with a rotor and slotted stator mixing head, also called a homogenizer, for more advanced deagglomeration and emulsification capabilities. The product also features a two-wing anchor that promotes bulk flow and uniform batch temperature.

The ROSS Model CDA-25 (pictured) includes dry-running Double FlexiLip seals on both agitator shafts, making it appropriate for vacuum operations up to 29.5” Hg. This model also features a portable mixing vessel with heating/cooling jacket.

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ROSS Dual-Shaft Mixer is designed to place intense shearing and homogenization at the forefront.

Dual-Shaft Mixer with High Shear Rotor/Stator from ROSS

Syntegon’s integrated syringe visual inspection line features a de-nester, a re-nester, and built-in artificial intelligence (AI) functionality for the inspection of syringe flanges, stoppers, and cylinders. The system, which can output up to 18,000 syringes per hour, is based on the company’s AIM5 series. 

The AI vision system is designed to increase detection rates and decrease the number of false rejects for highly viscous parenteral solutions with air bubbles. Static Division technology is used to perform the visual particle inspection. A high-voltage leak detection module can be integrated for CCI testing.

Syntegon's Syringe Inspection Line utilizes an AI vision system for the inspection of syringe flanges, stoppers, and cylinders.

Syringe Inspection Line

Bürkert Fluid Control Systems offers a scalable chemical disinfection system that features a compressed air-operated dual-substance nozzle that provides homogenous and fine aerosol formation of hydrogen peroxide with minimal chemical and energy input. 

The system is designed for applications like sterilizing packages, cleaning HEPA filters, or disinfecting rooms. In operation, hydrogen peroxide is pumped from a stainless-steel container to a liquid flow controller. Atomizing air is metered to the nozzle through a mass-flow controller, producing a fine mist. The measured material flows enable the control of disinfection time. 

The modular preparation system and can be customized to suit customer needs to include heaters, integrated flushing, safety devices, or control cabinet integration with programmatic logic controllers.

Bürkert's Fluid Control System offers customers scalable hydrogen peroxide disinfection.

Hydrogen Peroxide Dispensing System

On July 29, 2021, Emergent BioSolutions announced that FDA is allowing the company’s Bayview manufacturing facility in Baltimore, Md., to resume production of Johnson & Johnson’s (J&J) COVID-19 vaccine bulk drug substance. FDA’s decision comes after doing extensive reviews and is based on the diligent work and close coordination Emergent has conducted with J&J and the agency to execute a quality enhancement plan.

Since production was paused, Emergent has been working closely with FDA and J&J to address quality concerns and has developed and executed an action plan as well as committed extensive resources to bring operations up to FDA standards. The company expects to continue working with the agency throughout the manufacturing process to help ensure the stability of the J&J COVID-19 vaccine supply chain.

“We are proud to be resuming production of bulk COVID-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners,” said Robert Kramer, Emergent’s CEO, in a company press release. “We are in the unique business of producing life-saving medications for catastrophes that we hope never occur [such as] anthrax attacks, opioid overdoses, and COVID-19.”

“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” Kramer added. “We have fallen short of those lofty ambitions over the past few months, but resumption of manufacturing is a key milestone, and we are grateful for the opportunity to help bring this global pandemic to an end. We’d like to thank our government partners as well as Johnson & Johnson for their support.”

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

FDA Gives Green Light to Emergent BioSolutions to Resume COVID-19 Vaccine Manufacturing

Entries are open for the 18th Annual CPhI Pharma Awards, which are slated to take place on November 9, 2021, in Milan, Italy, at the Stella Polare Convention Centre. Awards in fifteen categories will be given out to innovators and thought leaders who are exploring uncharted territory in the pharma/biopharma industries.

Anyone involved in design, development, manufacture, supply, and distribution of large- and small-molecule drug products may apply. Winners will be selected by a panel of expert judges. The deadline for applications is August 6th, 2021.

This event is part of CPhI Worldwide, a pharma exhibition taking place November 9–11, 2021. Last year, the convention was cancelled as a result of the COVID-19 pandemic, with the entirely virtual CPhI: Festival of Pharma held in its place. This year’s event will be a hybrid of in-person and virtual activities.

“We host our awards because it’s important to recognize the innovative and inspirational work that is produced across the pharmaceutical industry” said Tara Dougal, head of content and insights, Informa Markets, in a July 19, 2021 company press release. “After a challenging year, the industry has been more committed than ever to advancing health and improving patient outcomes. It’s been a year in which we have seen the very best of pharma, with a record pace of innovation, discovery, and commercialization.”

The full awards list and submission requests can be found at 

Entries are now open for the 18th Annual CPhI Pharma Awards in Milan.

18th Annual CPhI Pharma Awards to Take Place in Milan, Italy

On July 29, 2021, VICO Therapeutics, a Netherlands-based biotech company focused on the development of RNA-modulating therapies for rare neurological disorders, announced that FDA had granted orphan drug designation (ODD) for VO659, an investigational antisense oligonucleotide therapy (AOT), in the treatment of Huntington’s disease (HD).

HD is a rare degenerative brain disease that results in motor disorders, impaired cognition, dementia, and various psychiatric manifestations. It is caused by a mutation to the CAG-trinucleotide repeat in the coding region of exon 1 of the HTT gene, resulting in a mutant huntingtin protein with an elongated polyglutamine (polyQ) stretch at its N-terminus. This grants a toxic gain-of-function to mutant protein forms, which results in widespread neuronal death.

VO659 is designed to suppress mutant proteins with the intent of slowing or halting the progression of disease. A month prior to this announcement, the drug had also received orphan drug designation for the treatment of spinocerebellar ataxia, a group of hereditary polyQ disorders that result in similar neuron degeneration.

ODD is granted to drugs intended for the safe and effective treatment, diagnosis, or treatment of rare (fewer than 200,000 cases) diseases or disorders. This designation grants various benefits, including seven years of market exclusivity following regulatory approval, exemption from FDA application fees for Huntington’s disease, and tax credits for qualified clinical trials.

“We are delighted that [FDA] has granted this orphan drug designation following the ODD for SCA one month ago,” said Rupert Sandbrink, chief medical officer at VICO, in a company press release. “This is affirmation of the potential of our [antisense oligonucleotide platform] approach.”

VICO Therapeutics’ drug candidate, VO659, for treating Huntington’s Disease was granted orphan drug designation by FDA. 