Lab Operations Improvements

Revolutionary therapies and innovative drugs can largely be attributed to the research, development, and manufacturing work conducted by the bio/pharm industry. Contributing to that success, however, are the contributions of laboratory technology manufacturers.

As much as new therapeutics are continually discovered, researched, and developed, innovative laboratory equipment is continually being developed, improved upon, and intro- duced to the market. A primary goal of these lab equipment innovations is to improve the efficiency of the drug develop- ment cycle or unlock as yet unknown benefits for researchers. A summary of some of the most recent product innovations to hit the laboratory scene are highlighted below.

Refeyn's SamuxMP Mass Photometer

Announced in January 2022, Refeyn’s SamuxMP mass photometer is designed to be used with only basic train- ing. Intended for use in adeno-associated virus (AAV) analytics, it has a mass range tailored for AAV analy- sis and provides accurate results in less than five min- utes from sample loading to final result. Combined with low-operational costs and a small footprint, the SamuxMP enables routine quantification of empty/full AAV capsid ratios, even in smaller labs, to set a new stan- dard in AAV characterization.

The SamuxMP is designed to overcome the drawbacks of the current analytical methods by enabling users to rapidly and cost-effectively determine empty/full capsid ratios for AAVs of any serotype at the bench using very low sample volumes and concentrations with minimal sample preparation. This is intended to enhance produc- tivity and speed up workflows through more frequent analyses in-house, making R&D and process development of gene therapies and AAV-based therapeutics signifi- cantly more efficient (1).

Bio-Rad's Bio-Plex Pro Human SARS-CoV Variant Neutralizing Antibody Assays

Bio-Rad Laboratories announced in December 2021 that it would be offering new Bio-Plex Pro Human SARS-CoV Variant Neutralizing Antibody Assays for use in measuring neutralizing antibodies. The product con- sists of a ready-to-use 96-well kit containing premixed magnetic capture beads, a detection converting enzyme (ACE)-2 receptor, a standard and positive control, and buffers that measure levels of neutralizing antibodies and percentage inhibition of the ACE-2 receptor binding the viral antigens coupled on the beads.

The assays are being offered in an 11-plex complete all-in-one kit format that consists of wild-type receptor-binding domain and S1 and 9 variant antigens, customizable sin- gleplex assays, and 2-plex Delta variant coupled beads. Additionally, a custom Assay Developer Kit to create assays for any new SARS-CoV-2 variant—such as Omicron—is included. This customizability may prove invaluable as mutant strains of COVID-19 continue to develop (2).

BioChromato's Smart Evaporator C1

In November 2021, BioChromato released data supporting the notion that its Smart Evaporator C1, designed for preparing microbial degradation culture media for analysis, can utilize a novel bioremediation technique to improve the detoxification process for persistent organic pollutants (POPs) that cannot be decomposed by natural processes in soil.

According to an interview the company had with an anonymous researcher, various advantages were found relative to rotary evaporators:

• The Smart Evaporator C1 can evaporate culture medium samples without azeotroping, saving a significant amount of time relative to rotary evaporators.
• Rotary evaporators are at risk of water contamination from the steam adsorbed from the water heating bath. The CI instrument avoids this risk because it does not need water.
• Researchers no longer have to monitor the process to avoid solvent bumping— because the C1 instrument operates under normal pressure, samples can be left unattended (3).

OpenEye's Orion Antibody Discovery Suite

OpenEye, in a partnership with Specifca, launched the Orion Antibody Discovery Suite, a jointly developed software, in December 2021. Orion is designed to identify diverse antibody sets with better properties for down- stream therapeutics development. The product exclusively features Specifica’s AbXtract software, an antibody discovery module that uses proprietary artificial intelligence methods to analyze large amounts of sequence data.

OpenEye claims that Orion is the only cloud-native fully integrated software-as-a-service molecular modeling platform. Orion uses Amazon Web Services, which provides it with unlimited storage and computational scal- ability in tandem with its data sharing, visualization, and analysis tools (4).

MilliporeSigma's ColorWheel Flow Cytometry Antibodies and Dye

Announced in November 2021, MilliporeSigma’s ColorWheel Flow Cytometry Antibodies and Dyes present the latest advancements in cytometry profile technology. The product allows users to select antibodies and dyes for assembly in any desired combination, resulting in an output of mix-and-match antibodies and dyes analogous to a primary conjugated antibody.

According to MilliporeSigma, multiplexing in flow cytometry can be difficult because researchers must consider instrument configuration, antigen expression and dye brightness balance, and antibody–dye combination avail- ability. In this regard, the ColorWheel is designed to overcome these constraints by making it easier to build a new multiplex assay for samples with varying expression levels of antigen.

Other notable features of the ColorWheel include:

• Flexibility to pair any antibody with any dye in a ready-to-use, convenient format
• Can be used in five minutes of hands-on time, minimizing necessary time and effort
• Preservative-free presentation that promotes sustainability and wider sample type compatibility
• Lyophilized product, enhancing stability and allowing for ambient shipping (5).

Satrotius' Sartolab RF|BT 150–1000 Vacuum Filtration Units

Sartorius introduced the new Sartolab RF|BT 150–1000 Vacuum Filtration Units in November 2021. Designed to offer faster and higher capacity filtra- tion, the new filtration units also allow for enhanced physical stability for a wide range of sample types through a newly optimized center of gravity.

The RF|BT 150–1000 has an increased membrane surface area designed to facilitate optimal filtration. Additionally, there is an 0.45- μm polyethersulfone membrane in place of the 0.45-μm cellulose acetate membrane, which increases flow rate while keeping the same low-protein binding properties.

The new units can be directly used on the Sartolab Multistation for par- allel filtration. Additionally, the new vacuum filtration units are available in three different pore sizes to meet the needs of most applications:

• 0.1 μm: mycoplasma removal
• 0.22 μm: sterile filtration of cell culture media, buffers, and reagents
• 0.45 μm: clarification of aqueous and viscous solutions (6).

Thermo Fisher Scientific's Orbitrap Exploris MX Mass Detector

Thermo Fisher Scientific unveiled the Orbitrap Exploris MX Mass Detector at the 69th American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics in October 2021. The new mass detector allows biopharmaceutical laboratories to implement multi-attribute method (MAM), an analytical extraction technique that can extract large amounts of different quality parameters of a protein via a single analytical approach.

In addition to MAM, the Orbitrap can perform intact analysis of monoclonal antibodies, conduct oligonucleotide mass determination, and carry out peptide mapping. According to Thermo Fisher, this instrument simplifies the transition of biotherapeutics from development to manufacturing and enables quality control customers to use the same method established earlier in a molecule’s journey to commercialization. This design is intended to accelerate the overall biopharma development pipeline (7).

CuriRx's CuriLytics Platform

CuriRx announced the CuriLytics Platform in September 2021. Designed to support the development of complex biotherapeutics, CuriLytics uses high-resolution mass spectrometry and various orthogonal characterization methods to characterize modern bio- pharmaceutical drugs, including:

• Recombinant proteins
• Monoclonal antibodies
• Bispecific antibodies
• Vaccines
• Antibody drug conjugates
• Oligonucleotides
• Gene therapy products.

Ultimately, the platform can iden- tify quality attributes of protein can- didates at the individual residue level, which can be used to provide context to effects brought about by changes to the process or production of the drug (8).

Bürkert Fluid Control Systems

Bürkert Fluid Control Systems new scalable chemical disinfection system features a compressed air-operated dual-substance nozzle that provides homogenous and fine aerosol formation of hydrogen peroxide with minimal chemical and energy input.

The system is designed for applications such as sterilizing packages, cleaning high efficiency particulate air filters, or disinfecting rooms. In operation, hydrogen peroxide is pumped from a stainless-steel container to a liquid flow controller. Atomizing air is metered to the nozzle through a mass- flow controller, producing a fine mist. The measured material flows enable the control of disinfection time.

The modular preparation system can be customized to suit customer needs to include heaters, integrated flushing, safety devices, or control cabinet integration with programmatic logic controllers (9).

Lasair Pro Airborne Particle Counter

The Lasair Pro Airborne Particle Counter from Particle Measuring Systems, announced in July 2021, supports a range of applications, including clean-area monitoring and classification while meeting international cleanroom certification standards.

The instrument is designed to meet increasing data integrity and regulatory requirements, featuring integrated audit trail capabilities. Sampling activities can be programmed and managed locally or remotely. Collected data are securely saved and transferred to meeting data integrity-related standards such as 21 Code of Federal Regulations Part 11.

The instrument can store up to 10,000 data samples and can be configured for up to 100 users. Unlimited users can access a near field communication card (10).

References

1. Refeyn, “Refeyn’s New SamuxMP Mass Photometer Promises to Significantly Improve AAV Workflows,” Press Release, Jan. 19, 2021.

2. Bio-Rad Laboratories, “Bio-Rad Introduces Bio-Plex Pro Human SARS-CoV-2 Variant Neutralization Antibody Assays to Quickly Measure Neutralizing Antibodies Against SARS-CoV-2 Virus,” Press Release, Dec. 20, 2021.

3. BioChromato, “Fast & Effective Evaporator Improves Bioremediation Sample Preparation,” Press Release, Nov. 26, 2021.

4. Specifica, “OpenEye Scientific And Specifica Partner To Launch Orion Antibody Discovery Suite Incorporating AbXtract,” Press Release, Dec. 2, 2021.

5. BioPharm International, “MilliporeSigma Unveils ColorWheel Flow Cytometry Portfolio,” Biopharminternational.com, Nov. 24, 2021.

6. Sartorius, “Sartorius Introduces Faster, Higher Capacity Sartolab RF|BT Vacuum Filtration Units,” Nov. 1, 2021.

7. Thermo Fisher Scientific, “Thermo Fisher Scientific Launches
New Mass Spectrometry and Chromatography Solutions at ASMS 2021,” Press Release, Nov. 1, 2021.

8. CuriRx, “CuriRx Launches CuriLytics Platform to Provide CMC Analytical Services to Support Complex Biotherapeutic Development Using High Resolution Mass Spectrometry,” Press Release, Sep. 21, 2021

9. Pharmaceutical Technology, “Hydrogen Peroxide Dispensing System” PharmTech.com, August 2, 2021.

10. Pharmaceutical Technology, “Airborne Particle Counter,” PharmTech.com, July 2, 2021.