Pharmaceutical Technology Editors

The European Medicines Agency (EMA) announced on July 22, 2022 that it is endorsing a 

statement published by the International Coalition of Medicines Regulatory Authorities (ICMRA) 

calling for the international collaboration in generating and using real-word evidence to make regulatory decisions. The statement was developed after the completion of a workshop organized by EMA, FDA, and Health Canada in June 2022. 

Real-world data and evidence are increasingly being used in the development, authorization, and monitoring of drug products, according to EMA, and use of such data can fill knowledge gaps. However, the quality of data, the sources of data, and the processes for sharing data are still challenges.

Regulators have worked together during the COVID-19 pandemic to share data and experience and have agreed to continue to do so after the pandemic. ICMRA members have pledged to “to foster global efforts and further enable the integration of real-world evidence into regulatory decision-making” by harmonizing terminologies, converge real-world data and evidence guidance and best practice, address public health threats, and maintain transparency.

“Global regulators emphasize their commitment to steer the work in these areas which could be taken forward through a variety of existing fora, including the International Conference on Harmonization (ICH), international standardization bodies and clusters of interested regulators,” EMA stated in the press release.

Articles

A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.

EMA Endorses Statement on International Collaboration of Real-World Evidence

Hospira, a Pfizer company, announced on July 13, 2022 that the company is issuing a voluntary recall of one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), 100 mL Single Patient Use Glass Fliptop Vial; lot DX9067, to the user level due to a visible particulate observed in a single vial during annual examination of retain samples.

According to a Pfizer, patients receiving the impacted product are at risk for blockage of blood vessels, including decreased blood flow to the brain, heart attack, pulmonary embolus, and tissue necrosis. Hypersensitivity reactions and transmission of infectious disease can also occur.

Propofol is used for the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion, USP is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a single patient use fliptop vial.

The product lot was distributed nationwide in the United States from June 10, 2020 through June 26, 2020. Hospira has not received any reports of adverse events associated with this issue for this lot to date.

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate. 

Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP

TFF Pharmaceuticals announced on July 14, 2022 that it is significantly expanding its R&D operations through the lease of a new research and development facility located in Austin, Texas.

The 3,500-ft2 facility will increase TFF’s total lab space, adding a dedicated lab for downstream processing of products created via its Thin Film Freezing technology. The facility will also allow for more space to accommodate larger equipment to facilitate scale-up and manufacturing as well as product supplies for preclinical studies.

The company also plans to expand the product development team in Austin, which will be based at the new facility to support the company’s growing number of partnered projects. The facility will be supervised by Donald Owens, PhD, director of product development at TFF and supported by John Koleng, PhD, vice-president of product development and manufacturing.

“The opening of our new Austin R&D facility represents an important evolution of TFF’s operations, reflecting growing demand for our Thin Film Freezing technology and product development services,” Koleng said in a company press release. “The Austin facility will enable us to increase testing capacity so that we can run a larger number of feasibility studies, including a focus on biologics where demand has continued to grow. Additionally, as many of our partnered programs move to clinical evaluation, the ability to scale-up manufacturing in parallel becomes mission critical. We expect the new Austin facility will allow us to meet the current growing demand for Thin Film Freezing-based products.”

TFF Pharmaceuticals is expanding its R&D operations with a new facility in Austin, Texas. 

TFF Pharmaceuticals Expands R&D Operations with New Facility

PerkinElmer announced the addition of the PerkinElmer Flow Cytometry Instrument Concierge Services to its OneSource Laboratory Services portfolio on July 11, 2022. The concierge service is designed to provide biopharmaceutical labs with expert, on-site flow cytometry specialists to help manage instruments and processes, facilitating reduced downtime, increased productivity, and better data integrity and reproducibility.

According to a company press release, the service includes regulatory quality checks on cytometers, instrument cleanings and preventative maintenance, on-site troubleshooting, phone support, and initial repairs. Additional features include:

Instrument and software training and education

“Flow cytometry is an important part of drug discovery labs, but managing this complex technology in-house can be tedious and time consuming, especially for teams that lack expertise in this area or are experiencing high staff turnover,” said Gary Grecsek, vice president/general manager of OneSource Enterprise Laboratory Services, PerkinElmer,in the press release.“With our OneSource Concierge Service for flow cytometry, lab managers and scientists don’t have to spend time managing these instruments and processes and can focus on other critical efforts and discovering new drug candidates.”

The PerkinElmer Flow Cytometry Instrument Concierge Services will provide biopharmaceutical labs with expert, on-site flow cytometry specialists.

PerkinElmer Introduces New Cytometry Management Service

Cytiva announced on July 13, 2022 that it had acquired a new manufacturing facility in Muskegon, MI. The new facility, a chromatography resins manufacturing site, is part of Cytiva and Pall Corporation's $1.5 billion capacity expansion investment, allowing Cytiva to expand its resin manufacturing beyond Sweden.

According to a company press release, Cytiva plans to renovate the site into a 168,000 ft² biomanufacturing center consisting of multiple buildings; it will house approximately 200 associates upon completion. With a planned construction start date in Q3 2022, manufacturing is expected to begin in 2026.

“When you’re looking to help provide global biotechnology solutions to the world, it requires you to be nimble and flexible,” said Emmanuel Ligner, Danaher Group Executive, president and CEO, Cytiva, in the press release. “By investing in Muskegon, Michigan, we will be closer to our North American customers, who are developing advanced biotherapeutics.”

Cytiva has acquired a new chromatography resins manufacturing site in the United States as part of its $1.5 billion capacity expansion investment.

Cytiva Acquires Chromatography Resins Manufacturing Facility in Muskegon, Michigan

Moderna announced on July 14, 2022 that Health Canada has approved the use of its messenger RNA (mRNA) COVID-19 vaccine SPIKEVAX for use in young children aged six months to five years. Prior to this authorization, children under five were the only age group not yet eligible in Canada for vaccination against COVID-19.

The vaccination is given in two doses completed in one month, the same as the primary dosing schedule as adults, adolescents, and children over five years of age. Health Canada previously approved the use of SPIKEVAX in individuals six years of age and older in March 2022.

"Since the pandemic began, we have worked with a deep sense of responsibility to deliver on the promise of mRNA science for Canadians," said Patricia Gauthier, president and general manager, Moderna Canada, in a press release. "This decision from Health Canada confirms the effectiveness and safety of Moderna's vaccine in this final and important age group. With this announcement, parents and caregivers now have an option to protect these very young children, a group at high risk of infection and where additional health prevention measures [such as] wearing masks may not always be feasible."

Health Canada has authorized Moderna’s COVID-19 vaccine for use in young children aged six months to five years.