Pharmaceutical Technology Editors

OpenEye Scientific and Specifa have jointly developed a software offering known as the OpenEye Orion Antibody Discovery Suite. The first offering from the suite will be AbXtract, an antibody discovery module developed by Specifica.

The Orion Antibody Suite has been described as the only cloud-native. fully integrated software-as-a-service molecular modeling platform, according to a Dec. 2, 2021, press release. The software suite is intended to combine the storage and computational scalability of Amazon Web Services with powerful tools for data sharing, visualization, and analysis in an open development platform.

AbXtract uses proprietary artificial intelligence methods to analyze large amounts of sequence data. The model is designed to help antibody engineers and bioinformaticians uncover diverse antibody sets with ideal properties for downstream therapeutics development.

“What AbXtract does is democratize the use of next-generation sequencing in antibody discovery, letting Orion take care of storage and analysis,” said Andrew Bradbury, co-founder and chief scientific officer of Specifica, in the press release. “Antibody discovery projects that were previously out of reach because of software, hardware, computation, or data sharing limitations have now become possible with AbXtract on Orion.”

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The partnership between OpenEye Scientific and Specifica has generated AbXtract, an antibody discovery model that is included in the Orion Antibody Suite.

OpenEye Scientific and Specifica Partner to Launch Orion Antibody Discovery Suite

FDA announced on Jan. 3, 2022, that it was amending the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to expand single booster doses to children 12 through 15 years of age. The agency reviewed data from Israel from individuals aged 12–15 who received a booster dose five months after the primary two-dose vaccination series, allowing FDA to reassess the risk/benefit of the use of boosters in younger adolescents.

“The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals,” FDA stated in a press release.

The EUA was also amended to shorten the time from primary vaccination to a booster dose to at least five months based on additional real-world data that has become available. The agency stated in a press release that no new safety concerns have been seen in the 4.1 million individuals over 16 years old in Israel who have received a booster dose at least five months after they received their first two doses.

“Additionally, peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine greatly improves an individual’s antibody response to be able to counter the omicron variant. Authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant. Given the demonstrated safety and effectiveness of a booster dose when administered five months after the primary vaccination series, and the fact that a booster dose may help provide better protection against the rapidly spreading omicron variant, the FDA has determined that the known and potential benefits of administering a booster to individuals ages 12 and older at least five months following completion of the primary vaccination series, outweighs the known and potential risks,” the agency stated in the press release.

FDA will also allow children ages 5–11 who have undergone solid organ transplants or have immunocompromised conditions to receive a third primary series does to maximize the benefit of the Pfizer-BioNTech vaccine.

“The agency used prior analyses conducted as part of the authorization process for healthy children to inform safety in this population and determined that the potential benefits of the administration of a third primary series dose at least 28 days following the second dose of the two-dose regimen, outweighed the potential and known risks of the vaccine. To date, the FDA and CDC have seen no new safety signals in this age group,” the agency stated.

“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said Acting FDA Commissioner Janet Woodcock, M.D., in the press release. “With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight COVID-19.”

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” said Peter Marks, M.D., PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the release. “With this in mind, the FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals.”

The agency is expanding the use of a single booster of the Pfizer-BioNTech vaccine to children ages 12–15 and is shortening the time between primary vaccination and booster to at least five months.  

FDA Expands Use of Pfizer-BioNTech COVID-19 Vaccine

Scitara’s Scientific Integration Platform (SIP) is a cloud-native infrastructure designed to realize the full benefits of digital transformation. SIP establishes a flexible, adaptable framework that facilitates a fully connected laboratory and an 

 configurable platform. Its flagship technology, the Scitara Digital Lab Exchange, forms an independent, vendor-agnostic integration layer.

SIP enables laboratories and science-based organizations to access the advantages of data mobility, independent of any digital platforms that have already been deployed. It automates scientific data exchange across various endpoints and interfaces existing various informatics platforms, as well as instrument-specific analysis systems.

Scitara’s Scientific Integration Platform (SIP) establishes a flexible, adaptable framework that facilitates a fully connected laboratory.

Digital Integration Platform

Thermo Fisher Scientific’s Invitrogen TrueCut Hifi Cas9 Protein is designed for research applications that require highly precise genome editing, such as the engineering of chimeric antigen receptor (CAR)-T cells and the creation of cellular models for disease discovery.

The Invitrogen TrueCut HiFi Cas9 Protein significantly reduces off-target events while retaining maximum on-target editing efficiency. It does this by minimizing edits in unintended locations, which are disruptive in translational research, drug screening, and drug modeling.  It has demonstrated near complete elimination of off-target effects compared to wild-type Cas9 in several cell types, including T cells and induced pluripotent stem cells (iPSCs), as well as shown improved off-target profiles relative to similar proteins.



Thermo Fisher's Invitrogen TrueCut HiFi Cas9 Protein significantly reduces off-target events while retaining maximum on-target editing efficiency.

Next-Generation Cas9 Proteins

Suncombe’s MicroEDS BioWaste Treatment System

Suncombe’s MicroEDS BioWaste Treatment System is a biologically hazardous waste decontamination unit that can process between 150 to 500 L of waste per day. The low-volume system is certified to ASME and ISO/EN standards for treating biosafety level 1, 2, and 3 waste through an innovative batch process that allows for the positive release of all collected waste.

Advances in the MicroEDS include thermal energy regeneration, low energy usage, and 100% positive release for treated waste and electronic records generation. The system is designed to operate at a thermal treatment parameter of 121 °C for 15 minutes, as well as variable temperature, time and f0 lethality settings, for specific requirements.

According to Suncombe, the new unit delivers at least 61% energy saving relative to prior models and can reduce energy usage and utility consumption by up to 75%. Additionally, based on average use, it reduces the carbon footprint by up to 1.68 tons of carbon dioxide each year.

The MicroEDS BioWaste Treatment System can process between 150 to 500 L of waster per day.

Sustainable Biowaste Treatment System

Moderna released new data on Dec. 20, 2021, detailing the efficacy of its COVID-19 vaccine against the novel Omicron variant. Similar to the data 

, Moderna’s two-dose regimen had relatively low levels of neutralizing antibodies effective against the Omicron variant. However, the currently authorized 50 µg booster shot increased neutralizing antibody levels approximately 37-fold, while a 100 µg dose increased them approximately 83-fold.

According to a company press release, the data set included 20 booster recipients each of mRNA-1273 at the 50 µg and 100 µg dose levels, multivalent candidate mRNA-1273.211 at the 50 µg and 100 µg dose levels, and multivalent candidate mRNA-1273.213 at the 100 µg dose level. All groups had low neutralizing antibody levels in the Omicron PsVNT assay prior to boosting.

At day 29 post-boost, the authorized 50 µg booster of mRNA-1273 increased neutralizing geometric mean titers (GMT) levels against Omicron to 850, approximately 37-fold higher than pre-boost levels. At this same interval, the 100 µg dose booster of mRNA-1273 increased the neutralizing GMT levels to 2228, which is approximately 83-fold higher than pre-boost levels. The multivalent candidates boosted Omicron specific neutralizing antibody levels to similarly high levels at both the 50 µg and 100 µg levels.

“The dramatic increase in COVID-19 cases from the Omicron variant is concerning to all. However, these data showing that the currently authorized Moderna COVID-19 booster can boost neutralizing antibody levels 37-fold higher than pre-boost levels are reassuring,” said Stéphane Bancel, CEO, Moderna, in the press release. “To respond to this highly transmissible variant, Moderna will continue to rapidly advance an Omicron-specific booster candidate into clinical testing in case it becomes necessary in the future. We will also continue to generate and share data across our booster strategies with public health authorities to help them make evidence-based decisions on the best vaccination strategies against SARS-CoV-2.”

In the release, Moderna also announced that they will continue developing their Omicron-specific booster candidate, mRNA-1273.529. The company expects it to advance into clinical trials in early 2022.

Moderna’s vaccine is weaker against the Omicron variant, but boosters can increase neutralizing antibody levels by as much as 83-fold.