Pharmaceutical Technology Editors

The ROSS Ribbon Blenders custom-built for multiphase mixing are now available with an optional pressure feed vessel. When minor liquid ingredients must be thoroughly blended into powder or other solids, a pressure feed vessel enables complete discharge of the liquid component, ensuring even mixing and consistent batches. 

Designed for compressed air supply up to 20 psig or higher, a distinguishing characteristic of the pressure feed vessel is the absence of residual product in the piping. After the blending cycle, the pressure feed vessel can also assist with clean in place/washdown. 

Available in various sizes to accommodate the required volume of the additive liquid phase, these vessels are mounted and plumbed to ROSS Ribbon Blenders which range from 1/2 to 500 ft.³ working capacity.

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The ROSS Ribbon Blenders ensures even mix and consistent batches.

Pressure Feed Vessel

Allergan, a subsidiary of AbbVie, announced on Oct 29, 2021, that FDA approved Vuity (pilocarpine hydrochloric acid ophthalmic solution) 1.25% for the treatment of presbyopia, also known as age-related blurry near vision, in adults. According to a company press release, Vuity is the first and only FDA-approved eye drop to treat this condition, which affects an estimated 128 million Americans.

FDA approval came after two Phase III clinical studies, GEMINI and GEMINI 2, designed to evaluate the safety, tolerability, and efficacy of Vuity in the treatment of presbyopia. Both studies met the primary endpoint of improving near vision in low light conditions without a loss of distance vision on day 30 at hour three. Improvement was seen as early as 15 minutes and lasted 6 hours.

"Most adults cope with presbyopia, or difficulty with near vision, as we age. Beginning around the age of 40, many find themselves using reading glasses, holding text further away, or even increasing the font size and lighting on screens to try to see more clearly," said Michael Severino, vice-chairman and president, AbbVie, in the press release. "We are proud to offer [Vuity] as a first-of-its-kind once-daily eye drop that we believe will change the way people and their eye doctors approach presbyopia. The FDA approval of [Vuity] exemplifies our continued pursuit of innovative new treatments that push the boundaries of what's possible in eye care."

"As we age, the lenses of our eyes become less flexible, making it more difficult to focus on things up close. [Vuity] offers a novel, safe, well-tolerated and effective alternative to current options for managing age-related blurry near vision," said George O. Waring IV, medical director of the Waring Vision Institute South Carolina, and GEMINI 1 and GEMINI 2 principal study investigator, in the press release. "I am particularly encouraged by the rapid onset of action and duration of efficacy for [Vuity] to improve near and intermediate vision without impacting distance vision with one drop daily, particularly for those with mild to moderate presbyopia."

Abbvie’s Vuity (pilocarpine HCI ophthalmic solution) is the first and only eye drop to receive FDA approval for the treatment of presbyopia.

FDA Approves AbbVie’s Vuity for Presbyopia Treatment

FDA announced that it has granted an Emergency Use Authorization (EUA) to the Pfizer-BioNTech COVID-19 vaccine for use in children ages five to 11 in an October 29, 2021, press release. According to the release, the decision was based on a detailed evaluation of all available data, including a 

 from the FDA Vaccines and Related Biological Products Advisory Committee given three days prior to this announcement.

In the data cited by FDA, immune responses of children ages five through 11 were found to be comparable to those of individuals 16 to 25 years of age. In a preliminary analysis of the results conducted seven days after the second dose, three cases of COVID-19 occurred in 1305 recipients of the vaccine, whereas 16 occurred in the 663 placebo cases. Following these results, the vaccine was determined to be 90.6% effective in stopping COVID-19.

Children receiving the Pfizer-BioNTech vaccine will be given the same two-dose primary series, three weeks apart. However, the dosage will be 10 μg, one-third of the 30 μg dosage given to individuals 12 years of age or older.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said Acting FDA Commissioner Janet Woodcock in the press release. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

“[FDA] is committed to making decisions that are guided by science that the public and healthcare community can trust. We are confident in the safety, effectiveness, and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in the press release.

The Pfizer-BioNTech COVID-19 vaccine is the first to receive FDA Emergency Use Authorization for use in children ages five to 11.

FDA Grants EUA for Pfizer-BioNTech COVID-19 Vaccine Use in Children

Matica Biotechnology (Matica Bio), a contract development and manufacturing organization specializing in cell and gene therapy clinical and commercial manufacturing, announced a joint research agreement with Sartorius for advanced viral vector manufacturing technology on Oct. 18, 2021.

Under the agreement, Matica Bio and Sartorius will work on several studies together to streamline and optimize process analytical technology (PAT) technologies, automation software, and single-use platforms offered by Sartorius for large scale viral vector production. Together the partners will aim to solve the challenges of large-scale cell culture and viral vector production, improve manufacturability, and reduce the costs of novel cell and gene therapies, oncolytic vectors, and vaccines.

"The generation of in-line real-time process data is one of the most significant obstacles to achieving consistent, high-producing viral vector titers during development that can be translatable to large scale production. In many respects, what is going on inside a bioreactor or within downstream operations is still a black box to us," said Michael Stewart, chief technology officer at Matica Bio, in a company press release.

"Matica Bio's development, manufacturing and quality teams have decades of viral vector production experience. Applying our expertise together with Sartorius' industry-leading single-use and PAT technologies will allow us to provide more robust, consistent results for our clients, guiding informed decision-making throughout the manufacturing process and accelerating the overall development timeline to the clinic and market," Stewart added.

"We are extremely excited to initiate this partnership with Sartorius. Our number one priority is to deliver for our clients. Our expert staff will be working to integrate more fully automated processes leading to an increase in the speed of information flow and a reduction in preventable errors. The end result will be increased product yields [and] higher quality as well as improved flexibility and responsiveness to our clients' ever-changing needs," said Yun Jeong Song, CEO of Matica Bio, in the press release.

The research collaboration between Sartorius and Matica Biotechnology will aim to optimize PAT technologies, automation software, and single-use platforms for large-scale viral vector production.

Sartorius Forms Joint Research Pact with Matica Bio for Advanced Viral Vector Manufacturing Technology

Novavax announced that it had filed for authorization of its COVID-19 vaccine, NVX-CoV2373, in the United Kingdom and Australia on Oct. 27, 2021, and Oct. 29, 2021, respectively. The company’s conditional marketing authorization application filed with the UK Medicines and Healthcare products Regulatory Agency (MHRA) marks the first submission for authorization of a protein-based COVID-19 vaccine in the UK. The company’s application to the Therapeutic Goods Administration for provisional approval marks the first complete application for provisional approval of a protein-based COVID-19 vaccine in Australia.

Novavax expects to shortly complete additional regulatory filings in other key markets, including Europe, Canada, New Zealand, and the World Health Organization as well as other markets around the world. In the United States, Novavax expects to complete a submission package to FDA by the end of 2021.

“This [UK] submission brings Novavax significantly closer to delivering millions of doses of the first protein-based COVID-19 vaccine, built on a proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus,” said Stanley C. Erck, president and CEO, Novavax, in a company press release. “We look forward to MHRA’s review and will be prepared to deliver vaccine doses following what we anticipate will be a positive decision. We thank the clinical trial participants and trial sites in the United Kingdom, as well as the UK Vaccines Taskforce, for their support and vital contributions to this program.”

"[The Australian] submission brings Novavax significantly closer to delivering doses of the first protein-based COVID-19 vaccine to Australia and, along with this week's filing for conditional marketing authorization in the UK, brings us one step closer to our goal of ensuring broad global access to our vaccine," Erck said in the press release. "We thank the Australian clinical trial participants and trial sites, as well as the regulatory and vaccine experts, for their assistance and contribution to this vaccine program."

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2. It was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. The vaccine is formulated with Novavax' patented saponin-based Matrix-M adjuvant, which is designed to enhance the immune response and stimulate high levels of neutralizing antibodies.

Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia. 

Novavax Files for Authorization of its COVID-19 Vaccine in the UK and Australia 

The European Medical Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on Oct. 25th, 2021, that a booster dose of Moderna’s COVID-19 vaccine, Spikevax, may be considered in people 18 or older.

According to an agency press release, this decision was made following data showing that a third dose of Spikevax given six to eight months after the second dose led to a rise in antibody levels in adults with waning antibody levels. While CHMP stated that the data indicated that side effects following a booster are similar to what occurs after a second dose, rare side effects (such as inflammatory heart conditions) are being carefully monitored.

Following this recommendation, European public health bodies may issue official recommendations on booster doses at a national level. Earlier this month, EMA issued a similar recommendation for Comirnaty, the Pfizer-BioNTech COVID-19 vaccine.

EMA’s CHMP concluded that a booster dose of Moderna’s Spikevax vaccine may be considered in people aged 18 and older.