Pharmaceutical Technology Editors

Tergus Pharma, a US-based contract development and manufacturing organization (CDMO), announced on March 1, 2021 that Heather N. Sugrue will serve as the company’s vice-president of Business Development.

Prior to her new role at Tergus, Sugrue spent three years at Recro as the vice-president of sales and marketing and six years with Patheon Pharmaceuticals as the senior director of business development for the West Coast, Tergus said in a company press release. Before working at Patheon, Sugrue was employed at Ricerca Biosciences where she supported investigational new drug (IND)-enabling services from lead optimization through IND submission.

“Heather will play a critical role in Tergus’ growth in 2021 and beyond,” said Tergus Pharma chairman and CEO, Dr. Vijendra Nalamothu, in the press release. “Her breadth and depth of sales and business development in the CDMO space will be vital to managing and sustaining our commercial manufacturing expansion while we also maintain our leadership role in topical development. Under Heather’s leadership, Tergus will be expanding the sales team to focus on the growing needs of topical manufacturing in prescription brand and generic manufacturing as well as [over-the-counter] drug product manufacturing.”

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Heather N. Sugrue will serve as the company’s vice-president of Business Development.

Tergus Pharma Appoints New Vice-President of Business Development

Baxter and Moderna announced on March 8, 2021 that they have entered into an agreement where Baxter’s contract manufacturing organization, Baxter BioPharma Solutions, will provide fill/finish sterile manufacturing services and supply packaging for 60–90 million doses of the Moderna COVID-19 vaccine in 2021.

Under the terms of the agreement, manufacturing of the vaccine will take place at Baxter’s fill/finish sterile manufacturing facilities located in Bloomington, IN, Baxter said in a company press release. Additional details of the partnership were not disclosed.

“We have seen a remarkable demonstration of scientific and health care expertise in the effort to develop vaccines for COVID-19,” said Marie Keeley, vice-president, Baxter BioPharma Solutions, in the press release. “Baxter is honored to provide our deep expertise in vaccine manufacturing to help partners like Moderna bolster the supply of their vaccine.”

“We welcome the opportunity to work with Baxter BioPharma Solutions on fill/finish manufacturing for the Moderna COVID-19 vaccine in the [United States],” added Juan Andres, Moderna’s chief technical operations and quality officer, in the press release. “This additional production will help us continue to scale up our manufacturing capacity in the [US].”

Manufacturing of the vaccine will take place at Baxter’s fill/finish sterile manufacturing facilities located in Bloomington, IN.

Baxter to Provide Fill/Finish and Packaging Services for Moderna’s COVID-19 Vaccine

LabVantage Solutions announced three enhancements to its laboratory information management systems (LIMS) offerings in a virtual press conference on March 8, 2021, part of Pittcon 2021.

The company has added validation to three of its subscription-based software-as-a-service (SaaS) LIMS for regulated sectors, including the pharmaceutical industry. LabVantage Pharma, LabVantage Biobanking, and LabVantage COVID-19 LIMS now offer SaaS validation.

Evidence of validated control provides a record that the software is held to a set standard for data integrity and control and the responsibility rests with the vendor.

Customers pay an annual subscription fee to access the LabVantage LIMS, electronic laboratory notebook, laboratory execution system, and scientific data management system. Validated software updates are implemented by the company. A vendor-validated SaaS LIMS allows customers to expand the system to other locations, subsidiaries, and partners, the company reported.

The company also announced the launch of LabVantage Analytics, a self-service advanced analytics solution that allows users to explore, analyze, and visualize LIMS, enterprise, and external data for business insights. The offering integrates with the LabVantage LIMS platform

LabVantage Analytics enables laboratory managers and business colleagues both inside and outside the lab control of LIMS data together with relevant business and external data.

The tool analyzes structured and unstructured data from different sources, combining data ingestion, pre-processing, storage, analysis, and visualization into one application. Customizable dashboards and LIMS data reports enable users to access needed information.

In a third announcement, the company reported that LabVantage LIMS 8.6 has been designed and tested to optimum cybersecurity standards. The company has adopted SonarQube to scan source code for potential vulnerabilities; the use of Atlassian’s Jira software to track code and increase the visibility of security issues during development; and partnering with a third-party cybersecurity organization to test the software.

LabVantage LIMS features configurable security protocols and permissions that meet the requirements of the US Health Insurance Portability and Accountability Act, and the EU’s General Data Protection Regulation. Encryption is included in multiple stages and the company reports that it has been proactive in ensuring security through penetration testing and other activities to combat cyberattacks.

Validation for SaaS LIMS, advance analytics, and cybersecurity features announced during Pittcon virtual press conference.

LabVantage Announces Product Enhancements

on March 4, 2021 that its human medicines committee (CHMP) has begun a rolling review of the Sputnik V (Gam-COVID-Vac) COVID-19 vaccine. The review is based on results from laboratory and clinical trial studies that indicate the vaccine triggers the production of antibodies and immune cells. The rolling review will look at data as they become available and will continue until there is enough evidence to support a formal marketing authorization application. The usual standards for effectiveness, safety, and quality will be assessed by the agency for the vaccine, according to EMA.

Sputnik V (Gam-COVID-Vac) was developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. EMA states that the vaccine is made up of Ad26 and Ad5 adenoviruses that “have been modified to contain the gene for making the SARS-CoV-2 spike protein; they cannot reproduce in the body and do not cause disease. The two adenoviruses are given separately: Ad26 is used in the first dose and Ad5 is used in the second to boost the vaccine’s effect.”

The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).

Rolling Review of Sputnik V COVID-19 Vaccine Begins in Europe

on March 2, 2021 that, in collaboration with Health Canada, it has published the full clinical data set that was reviewed as part of the authorization of the Moderna COVID-19 vaccine. Publication of data is part of EMA’s efforts to be transparent in its authorization of COVID-19 vaccines.

“With the publication of the data package for Moderna’s COVID-19 vaccine, we are publishing the clinical reports that we assessed in support of the authorisation of this vaccine, and going forward, we will continue with this open data approach for all other COVID-19 vaccines,” said Emer Cooke, EMA’s executive director, in a press release. “EMA and Health Canada’s joint commitment to openness and transparency will support global research, allow for public scrutiny and reinforce society’s trust in COVID-19 vaccines as mass vaccination campaigns continue to be rolled out across the EU, Canada and the rest of the world.”

The published data are available on EMA’s clinical data website and Health Canada’s Public Release of Clinical Information portal. EMA stated that clinical data for the Pfizer-BioNTech vaccine will be published soon.

The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.

Clinical Data on Moderna COVID-19 Vaccine Published

A united effort between federal agencies is underway to combat COVID-19 fraud that ranges from the sale of misbranded drugs claiming to treat COVID-19 to products claiming to prevent the virus. The situation is being monitored by FDA’s COVID-19 Fraudulent Products Task Force. Operation Quack Hack has resulted in hundreds of these products being removed from the marketplace, and FDA has sent more than 120 warning letters to various companies selling these fraudulent products. Fake vaccines have also been reported for sale.

“Consumers should know the COVID-19 vaccines that the FDA has authorized under Emergency Use Authorization cannot be sold online. Legitimate COVID-19 vaccines are being distributed for free. Unfortunately, the agency is aware of reports of unauthorized websites and listings on online marketplaces purportedly offering COVID-19 vaccines for sale. When such online listings are found by or reported to the FDA, the agency notifies the online marketplaces, who can then remove the listings. We are also aware of emails sent to consumers featuring the FDA logo, advising consumers to call a phone number to schedule a vaccination. If consumers are contacted directly by someone who says they are from the FDA about a COVID-19 vaccine appointment, it is a scam,” said Judy McMeekin, Pharm. D., associate commissioner for Regulatory Affairs, in an 

FDA is asking the public to help by being alert about COVID-19 fraud schemes. Resources to help consumers protect themselves from fraud can be found on the agency’s 

The agency is working to identify and obstruct scammers looking to profit from the pandemic.