Avid Bioservices, a biologics-focused contract development and manufacturing organization, announced the opening of new analytical and process development (AD/PD) suites within their recently built 53,000-ft2 viral vector development and manufacturing facility. Build-out of the suites is currently ongoing and expected to be completed by mid-2023.

According to a June 14, 2022 press release, the new suites will be equipped with complete upstream, downstream, and analytical development capabilities. The suites will be able to support up to 500-L suspension culture in single-use bioreactors and various adherent cell modes. The company's viral vector AD/PD team has worked on technologies for viral vector production and purification processes focused on adeno-associated viruses (AAVs), lentiviruses, oncolytic viruses, and other viruses for gene therapy and vaccine applications.

“We believe that we are uniquely positioned to leverage our deep expertise in the manufacturing of traditional biologics to address the growing demand for high quality manufacturing of cell and gene therapies,” said Nick Green, president and CEO, Avid Bioservices, in the press release. “Today’s launch of our AD/PD labs is a crucial first step in our expansion into the viral vector space as we remain laser focused on smart and sustainable revenue growth for our business.”

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Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.

Avid Bioservices Launches New Analytical and Process Development Suites at Viral Vector Facility

According to a June 15, 2022 press release, a new polymer surface material has been invented by researchers at Chalmers University of Technology (Gothenburg, Sweden) that uses electrical signals to both capture and release biomolecules.

The new material may have an impact in the way that biomedicines are developed and could provide opportunities in the development of remote-controlled medication and electronic pills. The results of the research were published in a scientific journal, 

“Our polymer surfaces offer a new way of separating proteins by using electrical signals to control how they are bound to and released from a surface, while not affecting the structure of the protein,” said Gustav Ferrand-Drake del Castillo, doctor in Chemistry, Chalmers, CEO of Nyctea Technologies, and lead author of the study, in the press release.

The initial research behind the material was performed by Ferrand-Drake del Castillo while studying under the stewardship of Chalmers professor Andreas Dahlin within the university’s Division of Applied Surface Chemistry. The research project involved polymer surfaces that can change their state when the pH of the surrounding solution is adjusted—so, changing between neutral and charged.

“Shortly afterwards we discovered that we could use the electrical signals to control the binding and release of proteins and biomolecules, and that the electrode material works in biological solutions such as serum and centrifuged blood. We believe and hope that our discoveries may be of great benefit in the development of new medicines,” explained Dahlin, in the press release.

Additionally, the material was found to also work within biological fluids with the ability to counteract changes in pH values. Through this specific property of the polymer surface material, it may be possible for the researchers to create a new technique for implants and electronic pills, whereby the medicine is released within the body through electronic activation.

“You can imagine a doctor, or a computer program, measuring the need for a new dose of medicine in a patient, and a remote-controlled signal activating the release of the drug from the implant located in the very tissue or organ where it’s needed,” added Ferrand-Drake del Castillo. “Being able to control the release and uptake of proteins in the body with minimal surgical interventions and without needle injections is, we believe, a unique and useful property. The development of electronic implants is only one of several conceivable applications that are many years into the future. Research that helps us to link electronics with biology at a molecular level is an important piece of the puzzle in such a direction.”

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A new polymer surface material has been invented by researchers in Sweden that uses electrical signals to both capture and release biomolecules.

Researchers Invent New Material that Can Capture and Release Biomolecules

Bio-Rad announced the launch of the SEQuoia Express Stranded RNA Library Prep Kit on June 6, 2022. The kit is designed to construct robust libraries for efficient RNA sequencing (RNA-Seq) workflows in comprehensive transcriptome profiling.

According to a company press release, the SEQuoia is a three-tube kit that uses a novel reverse transcriptase and a ligation-free adaptor addition chemistry to produce a reproducible, quantitative RNA-Seq library in three hours. The kit allows researchers to construct robust libraries that capture messenger RNA and long noncoding RNA (> 200 binding proteins) transcripts for differential gene expression analysis and novel transcript delivery.

“Current RNA library preparation approaches are time-consuming, complex, and potentially error-prone, with sample loss observed at each stage in processes with multiple steps,” said Simon May, executive vice-president and president, Life Science Group, Bio-Rad, in the press release. “Bio-Rad offers scientists an enhanced solution, combining its rapid NGS [next generation sequencing] library preparation with integrated data analysis to overcome these difficulties and enable the widespread adoption of RNA-based sequencing."

Bio-Rad’s SEQuoia Express Stranded RNA Library Prep Kit is designed to construct efficient RNA sequencing workflows.

Bio-Rad Launches SEQuoia Express Stranded RNA Library Prep Kit

Axol Bioscience, a provider of induced pluripotent stem cell (ISPC)-derived cells, media, and characterization services for life science discovery, announced that its IPSC-derived ventricular cardiomyocytes have undergone comprehensive 

 pro-arrhythmia assay (CiPA) validation on June 7, 2022. This assay showed that the cells were suitable for measuring cardiotoxicity, which offers scientists a robust cardiac model for drug discovery and screening.

CiPa is a working group developed by FDA to assess the utility of human iPSC-derived ventricular cardiomyocytes by reproducing cardiotoxicity in a dish. The assay tests cells with 28 compounds that are known to be cardiotoxic and induce the fatal arrhythmia “Torsades de Pointes”. According to an Axol press release, Clyde BioSciences, a contract research organization that specializes in cardiotoxicity assays, used this assay to validate Axol’s cardiomyocytes for cardiac safety testing.

“As a core member of the CiPA initiative, we’re pleased to have supported Axol’s cell development and helped the team assess the performance of its cardiomyocytes,” said Godfrey Smith, chief scientific officer, Clyde Biosciences, in the press release. “Having run the CiPA protocol on Clyde’s proprietary CellOPTIQ platform, and provided analysis and interpretation of the data, we confirm our data indicate that Axol’s cardiomyocytes meet the requirements for predictive 

Axol’s human iPSC-derived ventricular cardiomyocytes provide a continuous source of cells from the same genetic background for use in multiple experiments and a physiologically relevant 

 research model of human heart cells. This allows for reliable, repeatable cardiotoxicity testing for drug candidates at scale.

“Scientists need cells and reagents they can rely on to make meaningful assessments of drug candidate toxicity, before progressing candidates to the clinic,” said Liam Taylor, CEO, Axol Bioscience, in the press release. “We’re both excited and proud to demonstrate the suitability of our human iPSC-derived ventricular cardiomyocytes for toxicity testing. Axol’s stringent quality control standards mean we have the capability to produce reliable, validated cells that scientists can use to assess a compound’s cardiac liability and, ultimately, help to improve the drug discovery process.”

Axol Bioscience’s CiPA-validated ventricular cardiomyocytes can be used as a robust cardiotoxicity measurement tool.

Axol Bioscience Announces CiPA-Validated Human Stem Cell-Derived Ventricular Cardiomyocytes

Bio-Rad Laboratories announced the launch of the CFX Duet Real-Time PCR System on May 26, 2022. The CFX Duet is designed to help researchers develop singleplex and duplex quantitative polymerase chain reaction (qPCR) assays.

According to a company press release, the CFX Duet is a two-color system that is factory calibrated for common dyes, allowing for the precise quantification of up to two targets in genotyping and multiple gene expression analysis without the need for passive reference dies. The device features thermal gradient functionality to enable optimization in fewer runs.

An additional fluorescence resonance energy transfer (FRET) mode supports protein melt analysis for basic protein characterization. The device uses CFX Maestro Software for easy experimental setup and analysis, allowing it to deliver customized reports without exporting data to other programs.

“We are pleased to expand our portfolio of qPCR instruments with the CFX Duet System to help customers run singleplex and duplex assays with a software that matches the robust thermal capabilities of our premium CFX Opus formats.” said Steven Blakely, director for gene expression and software technology, Bio-Rad, in the press release. “The versatile CFX Duet System allows users to quickly get started with gene expression, genotyping, quantification and thermal gradient optimization, as well as protein characterization using FRET.”

BioRad Laboratories CFX Duet System is designed to help researchers develop singleplex and duplex quantitative polymerase chain reaction assays.

Pharmaceutical Technology's In the Lab eNewsletter, July 2022

Avid Bioservices Launches New Analytical and Process Development Suites at Viral Vector Facility

Researchers Invent New Material that Can Capture and Release Biomolecules

Bio-Rad Launches SEQuoia Express Stranded RNA Library Prep Kit

Axol Bioscience Announces CiPA-Validated Human Stem Cell-Derived Ventricular Cardiomyocytes

Bio-Rad Launches CFX Duet Real-Time PCR System