Pharmaceutical Technology Editors

Waters Corporation and Genovis, a US-based enzymes and technologies provider, announced on April 13, 2021 that they have entered into a collaboration to develop and market complete routine biopharmaceutical characterization workflows based on the Waters BioAccord LC–MS System, Andrew+ pipetting robot, and Genovis SmartEnzymes.

Under the terms of the agreement, the companies will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control, Waters said in a company press release. The workflows in development will focus on product variant analysis, bioprocess stability monitoring, and biosimilar glycosylation analysis.

“Biologics analysis is an area that is ripe for improvement. What takes analytical scientists several days to do, should take hours or minutes instead,” said Jeff Mazzeo, vice-president, Global Marketing and Scientific Operations, Waters Corporation, in the press release. “Today, up-front sample preparation is a major bottleneck to productivity, largely due to the number of manual steps involved and the outmoded technology by which samples are readied for analysis. By combining Genovis’ SmartEnzymes with automation, liquid chromatography/time-of-flight mass spectrometry, and application-specific software workflows from Waters, we intend to move biotherapeutic analysis forward in ways never thought possible.”

“The BioAccord LC–MS system and the Andrew+ pipetting robot align perfectly with our strategies and vision at Genovis to bring simplified, robust, and automated enzyme-driven workflows to the biopharma industry,” added Fredrik Olsson, CEO, Genovis, in the press release. “The enzymatic workflows that we will develop in collaboration with Waters will help our customers in their efforts to bring safe and novel therapeutics to patients, faster.”

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Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.

Waters and Genovis to Partner on Biopharmaceutical Characterization Workflows

According to published reports (1–3), a global shortage of pipette tips is hindering the development and analytical testing of bio/pharmaceuticals by companies as well as the ability to conduct COVID-19 tests, among other health-related testing.

One report attributes the global shortage to a series of events that have recently plagued the pipette tip supply chain, including “blackouts, fires, and pandemic-related demand” (1). The shortage may also be putting pressure on biotech companies that are developing new therapeutics to prioritize which experiments they can conduct on new drugs being developed in their pipelines. However, thus far, biotech companies have been taking steps to conserve limited pipettes and have not had their work disrupted (1).

In December 2020, FDA added pipette tips and micro pipettes to its device shortage list (2), and, in March 2021, the results of a national survey of board-certified pathologists conducted by the College of American Pathologists showed that 45% of laboratories testing for COVID-19 have been having difficulties obtaining needed testing supplies. According to the survey, 30% of respondents reported having difficulty acquiring pipette tips within the previous three months (3). According to a press release, shortages of testing supplies place a substantial burden on laboratories that are diagnosing coronavirus disease. These shortages require national attention to mitigate the disruptions.

How Blackouts, Fires, and a Pandemic are Driving Shortages of Pipette Tips—and Hobbling Science

Medical Device Shortages During the COVID-19 Public Health Emergency

,” www.fda.gov, accessed April 29, 2021.
3. College of American Pathologists, “COVID-19 Testing Supply Shortages Disrupt 45% of Laboratories, CAP Survey Shows,” Press Release, March 11, 2021.

A shortage of pipette tips has been attributed to several factors, including the COVID-19 pandemic.

Pipette Tip Shortage Hinders Bio/Pharmaceutical Development and Testing

Berkeley Lights, a US-based digital cell biology company, announced on April 5, 2021 that it has launched Opto Assure, a series of assays that provide yield and product quality data at an earlier stage in cell-line development.

According to a company press release, the first series supports direct detection of product aggregates for a faster ramp toward volume production by evaluating biotherapeutic protein quality sooner in the antibody therapeutic development process, allowing for customers to rapidly choose clonal cell lines with promising manufacturability profiles.

“We’re excited to empower manufacturers of complex therapeutics, such as bispecifics, to develop better production cell lines faster. As we build out the Opto Assure series, customers can look forward to added capabilities that further reduce resources spent on preventing product failures downstream and ensure a more efficient process,” said John Proctor, PhD, senior vice-president of Antibody Therapeutics at Berkeley Lights, in the press release.

The company has introduced Opto Assure, a series of assays that provide yield and product quality data at an earlier stage in cell-line development.

Berkeley Lights Introduces Assay Series for Early Cell-Line Development Yield and Product Quality

Vyant Bio, an advanced biotechnology drug discovery company, Ordaōs Bio, an artificial intelligence (AI)-based drug discovery company, and Cellaria, a biotechnology company specializing in cell modeling, announced on April 22, 2021 that they have entered into a collaboration that will seek to de-risk the development of small-protein therapeutics. The partnership plans to unveil a model for rapid iteration of therapeutic design using AI and 

 “avatar clinical trials”. This model will enable the design, development, and testing of potential therapeutics on specific patient populations during preclinical development, with the goal to provide an early detection system of a drug’s efficacy in different patient cohorts prior to clinical trials.

Under the collaboration, each company’s unique capabilities will contribute to the design, manufacture, and testing of small-protein therapeutics that target multiple biomarkers derived from whole genome sequencing of patient populations. Ordaōs will use its proprietary AI to generate 

 protein sequences that will be designed to bind specific disease targets and will serve as a blueprint for the collaborative team’s experts in 

 preclinical drug discovery. This blueprint will be used to produce the prospective protein therapeutic and rapidly iterate the structure using an efficient expression system. Cellaria’s Patient Specific Cell Model Cohorts will be used to critically evaluate the purified protein for target binding and further optimize the protein to improve performance across an array of disease-specific genetic biomarker expressing cells. Once the protein is fully optimized by the team, Vyant Bio will aim to deliver regulatory readiness and a maximally de-risked drug candidate. The combined solution will provide data and human-based insights not usually available until after a costly clinical trial, the companies stated in a press release.

Cellaria uses cell biology in novel ways to provide insights into how a therapeutic may perform in specific patient populations, prior to clinical trials. In this collaboration, the company will provide the means for scientists to test how a drug will perform in a range of patient cohorts. The Cellaria 

 and three-dimensional models of tumor and metastatic niches are directly linked to a patient’s disease state and enable multiple parametric deep data sets in genomics, proteomics, and combinatorial analysis.

Ordaōs, meanwhile, uses generative AI technology to accelerate the mini-protein drug discovery and development process. In this collaboration, Ordaōs provides a pipeline of digitally optimized therapeutics for further development.

“Vyant Bio is committed to transforming the way that drugs are discovered by quickly adapting to exciting new technologies and combining capabilities in ways that leverage their strengths,” said Jay Roberts, CEO of Vyant Bio in the press release. “Our collaboration with Ordaōs and Cellaria allows us all to work together to design and develop superior therapeutics and position them to be as successful as possible before they get into the clinic.”

“Working with the Ordaōs and Vyant Bio teams has been incredibly important for us. Seeing the wealth of patient data and cells used so seamlessly to inform and guide the design of a therapeutic is highly rewarding,” added David Deems, president and founder of Cellaria, in the press release. “We are developing a repeatable process that leverages well-defined patient cohorts to learn as much as possible prior to embarking on a clinical trial.”

“We are very excited about working with Vyant Bio and Cellaria to further our vision for transforming the way we bring therapeutics to patients. At Ordaōs, we believe that designing, rather than discovering, drugs is now possible with AI and will allow us to think bigger when we envision the impact we can have on people’s lives,” said David Longo, CEO of Ordaōs, in the press release.

“The ultimate goal is to use modern AI to design the next generation of highly effective and safe biologics for treating cancer and inflammatory diseases, thereby creating transformative treatment options for potentially millions of patients worldwide. We expect that this new approach will significantly accelerate drug R&D overall and get the new drugs to patients much faster than with the traditional drug development approach. Patients who suffer from chronic and life-threatening diseases cannot wait. That is why this new collaboration is so important,” added Ülo Palm, Ordaōs’ chief medical officer, in the press release.

The three companies will continue to refine their strategies for drug design and development through a series of projects targeting cancer, pancreatic, and autoimmune disorders. As the project evolves, the therapeutic de-risking strategy will further incorporate the human-based biology and analytical software of StemoniX, a wholly owned subsidiary of Vyant Bio.

This new collaboration between Vyant Bio, Ordaōs Bio, and Cellaria mitigates risk in the drug discovery process using artificial intelligence and in-vitro “avatar” clinical trials.

Vyant Bio, Ordaōs Bio, and Cellaria, Collaborate on Biomarker-Specific Small Protein Therapeutics

Aigenpulse launched the CytoML 5.2, an update to its CytoML Experiment Suite, an automated machine learning solution aimed at streamlining and automating cytometry analysis at scale and replacing manual gating processes.

The new addition works to automate every stage in the flow cytometry data lifecycle by increasing the throughput of data processing and analytics by as much as 600%, increasing the accuracy, reproducibility, and quality of flow cytometry data. The new system also enables the reuse of processed cytometry data, the integration of population counts identified by manual gating to increase the value of the data, and allowing for cross-project analysis.

With new unbiased analysis features and an easy-to-use interface, the CytoML 5.2 uses a batch processing tool to engage a range of parameters used simultaneously to aid scientists in finding the best representation of their data. After significant clusters have been pinpointed, these clusters can be overlaid with marker expression and many types of meta-data to drive hypothesis testing. Meanwhile, the unbiased analysis features simplify the process of assigning identities to populations from clustering outputs.

“Unbiased analysis tools allow complex multi-dimensional data to be simplified, unified, processed, and visualized so that it can be more easily explored and compared,” said Satnam Surae, chief product officer at Aigenpulse, in an April 27, 2021 company press release. “This kind of analysis can be very useful in exploring data without any prior assumptions, as a means to uncover novel insights. It is a complementary technique to semi-automated approaches and is interoperable within the CytoML 5.2 Suite, enabling comparison and validation.”

With new unbiased analysis features and an easy-to-use interface, the CytoML 5.2 uses batch processing to engage a range of parameters used simultaneously for better data representation. 

Aigenpulse Updates its CytoML Experiment Suite with the CytoML 5.2

Cherwell introduced new models to its ImpactAir range of microbial air monitors distributed from Pinpoint Scientific.

The new ImpactAir-ISO-90 and ImpactAir-90 ranges are designed for use in high-grade areas within the pharmaceutical industry as well as other industries (e.g., healthcare, specialist food industries) where process monitoring of viable particles is necessary. Both ranges are equipped with a chamber for a 90-mm petri dish and use a slit-to-agar method that ensures particles, including microbes, impact the petri dish’s agar surface. As the dish rotates under the inlet, air is impacted onto an area of agar, reducing twin impingement risk and microbe desiccation for a high biological and physical efficiency.

Additionally, each range includes an ISO-90 Monitoring Head that contains all the controls needed to rotate the agar plate during the monitoring phase.

Individually, the ISO-90 range consists of:

The ISO-CON-90 Complete Monitoring System—a turnkey monitoring solution for isolators.

The ISO-90-V-Monitoring Head—designed for isolator manufacturers who perform their own flow control using their own vacuum source.

The ISO-90-N-POE Monitoring Head—formulated for bio-safety cabinets or isolators, the size and power of the vacuum pump have been reduced so the pump can fit into the monitoring head and does not require any external vacuum source or pipework.

The ImpactAir-90-B/M Portable Monitor—the first battery powered, slit-to-agar air monitor that is Annex 1 compliant.

The ImpactAir-90-HF High Flow Portable Monitor—a high-flow option ideal for the sampling of air in a much shorter time period or where large volume air samples are required.

“We are really excited by the opportunities that the new range of air monitors from Pinpoint offer,” said Andy Whittard, managing director at Cherwell, in an April 21, 2021 press release. “The compact, 90-mm Petri version slit-to-agar range can help users address the challenges presented by the new Annex 1 and the focus on continuous monitoring. The various options also provide users with differing solutions for challenges within their facilities.”

The new ImpactAir-ISO-90 and ImpactAir-90 ranges are designed for use in high-grade areas within the pharmaceutical, healthcare, and specialist food industries where process monitoring of viable particles is necessary.