Pharmaceutical Technology Editors

The European Medicines Agency (EMA) is providing support via its Innovation Task Force (ITF) for developers to help them reduce, replace, and refine animal use in drug development, it was revealed in a Sep. 29, 2021 press release.

ITF is a multidisciplinary group that offers a dedicated forum to discuss innovative aspects of development, providing opportunity for early dialogue between regulators and drug developers. Through ITF, EMA will be promoting the three principles of replace, reduce, and refine—commonly referred to as the 3Rs.

The forum will enable discussion of 3R-compliant methods and facilitate their integration into the development and evaluation of human and veterinary medicinal products. Additionally, this action by the regulatory body will aid the development and implementation of New Approach Methodologies (NAMs), which are in line with the legislation from the European Union on the protection of animals used for scientific purposes.

Services from ITF will be available free-of-charge, and any NAMs adhering to the 3Rs principles arising from the forum that can be used to fulfill testing requirements will be eligible for consideration. It is expected that by opening the ITF platform up to discussions about 3Rs-compliant methodologies, alternative methods will be integrated more quickly into the regulatory framework.

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EMA is providing support via its Innovation Task Force (ITF) for developers to help them reduce, replace, and refine animal use in drug development.

EMA’s Innovation Task Force Will Provide Support for Developers to Minimize Animal Testing

Codex DNA, a US-based company specializing in automated benchtop synthetic biology systems, released its first full-length synthetic genome for the delta variant of the SARS-CoV-2 virus (B.1.617 lineage) in early September 2021. The genome would allow researchers to further study the virus and can potentially accelerate the discovery and development of diagnostics, vaccines, and therapeutics to treat COVID-19.

Codex DNA synthesized and constructed the genome using its BioXp 3250 system, a fully automated synthetic biology benchtop workstation that enables the rapid, accurate, and reproducible writing of DNA and messenger RNA (mRNA). Synthetic genomes allow scientists to work safely with a replicated virus without the additional security measures required when working with that actual pathogen.

“Emerging SARS-CoV-2 variants continue to wreak havoc around the world. Codex DNA is committed to building and providing innovative synthetic tools that accelerate virus research and simplify the discovery and development processes,” said Todd R. Nelson, CEO of Codex DNA, in a Sept. 1, 2021, company press release. “We believe this new synthetic genome will be a key resource to identify, monitor, and combat the SARS-CoV-2 virus in our ongoing fight against COVID-19.”

In September, Codex DNA released a full-length synthetic genome for the SARS-CoV-2 delta variant, which may accelerate discovery and development of diagnostics and treatments for COVID-19.

Codex DNA Aims to Accelerate Virus Research with Full-Length Synthetic Genome for SARS-CoV-2 Delta Variant

LabVantage Solutions’ new LabVantage Enterprise SaaS offering launched in September 2021 adds full configurability and custom interfacing capabilities, incorporating the advantages of the company’s standard software-as-a-service (SaaS) option. These new features allow laboratories to fully leverage the SaaS laboratory information management system (LIMS) to address their needs, the company stated in a Sept. 15, 2021, press release.

The standard LabVantage SaaS includes electronic lab notebook, laboratory execution system, and scientific data management system features hosted in a multi-tenant cloud environment for a fee. According LabVantage in its press release, the SaaS option eliminates the upfront capital and start-up costs of a conventional LIMS while providing access to the LabVantage LIMS via web browsers. The SaaS is scalable and includes regular software updates that are automatically implemented by LabVantage. LabVantage Enterprise SaaS includes a managed and monitored computing infrastructure, automatic software upgrades, and enterprise-grade features.

With its configurability and custom interfacing support, the new system enables modifications that can accommodate the needs of more complex companies. Interfacing with external software systems is supported and features that are specific to individual needs has been added. The system can also be modified as an organization’s requirements change over time. Compared to the standard SaaS, Enterprise SaaS is hosted in a single-tenant cloud environment, which provides an added layer of security and flexibility.

Both the standard LabVantage SaaS and Enterprise SaaS solutions can be maintained by LabVantage for regulated industries that require a validated system. Maintenance can be implemented in a controlled and compliant manner, which provides evidence of installation qualification, testing, and change control.

“The standard LabVantage SaaS is a very popular option that works well for many customers; however, we have received many requests to go beyond the restrictions of a standard SaaS solution and offer a more configurable, flexible SaaS LIMS that allows organizations to fully configure and create customized system interfaces able to meet their specific needs,” said Robert Voelkner, LabVantage vice-president, Sales and Marketing, in the press release.

“We have developed the right balance with LabVantage Enterprise SaaS, keeping much of the simplicity, efficiency, and ease of use of the cloud-based standard SaaS approach, while adding abundant opportunities for the configurability and interfacing that allow customers to get the most value from their LIMS. It is noteworthy too that both our standard and Enterprise SaaS options can be maintained as a validated solution. Thanks to the creativity and innovative efforts of our stellar LabVantage team, we are proud to be the first and only company to offer a full featured, Enterprise SaaS LIMS system,” Voelkner added.

The new LabVantage Enterprise SaaS adds full configurability and custom interfacing capabilities.

LabVantage Solutions Now Offers LabVantage Enterprise SaaS

NewAge Industries, a tubing product manufacturer, announced that they had finished an expansion project at its southeastern Pennsylvania headquarters on Sept. 29, 2021. The company converted 3100 ft² of existing space at its Southampton, Pa., site into an additional ISO Class 7 certified clean room.

The new clean room is being used to manufacture molded connectors and tubing assemblies.According to a company press release, the decision was made as a result of the pandemic, as it increased demand for flexible tubing and single-use assemblies. The company has plans to build additional clean rooms in a 90,000-ft² building purchased in 2020 that is seven miles away from their main headquarters.

“We simply needed more room and equipment to make and assemble products,” said Ken Baker, CEO, in the press release. “We expanded our clean rooms just a few years ago, and this was another big undertaking. But it was necessary. We have customers who are depending on these critical items used in vaccine development and production.”

To facilitate the conversion, the company relocated an office, employee lockers, and a storage area. The renovated area then received injection molding presses, quality inspection tables, and assembly and packaging stations.

NewAge Industries has completed a plant expansion that added new cleanrooms to its headquarters in Southampton, Pa.

NewAge Industries Completes Plant Expansion

Gyros Protein Technologies, a peptide synthesizers and reagents provider, introduced the GyrolLab AAv9 Titer Kit on Sept. 30, 2021. The Gyrolab is designed for rapid determination of physical titer in adeno-associated virus serotype 9 (AAV9) vector-based cell and gene therapy manufacturing.

The Gyrolab is based on a highly selective AAV9 affinity ligand. The company indicated that the AAV9 serotype was used as a gene delivery vector because of its ability to cross the blood-brain barrier and target the central nervous system with high efficiency.

Gyros claims that the Gyrolab has an improved assay working range compared to enzyme-linked immunoassay (ELISA) methods and can generate 96 data points in 80 minutes. Additionally, the company states that it can handle 10x smaller sample volumes relative to ELISA methods.

“The addition of Gyrolab AAV9 Titer Kit to our portfolio of ready-to-use kits exemplifies our commitment to offering the whole range of tools required for analytical characterization during manufacturing and purification of cell and gene therapies,” said Mark Vossenaar, vice-president and general manager of Gyros Protein Technologies, in the press release. “Physical titer determination is one of the key quality attributes of the FDA process validation guidelines and our new kit will enable researchers to maximize performance and productivity when developing therapies based on the AAV9 serotype, which will ultimately reduce the time needed to produce patient treatments.”

Gyros’ new titer kit identifies adeno-associated virus serotype 9 in vector-based cell and gene therapy manufacturing.

Gyros Protein Technologies Announces New Titer Kit 

Catalyst Biosciences, a research and clinical development biopharmaceutical company, announced on Sept. 28, 2021, that FDA has granted orphan drug designation (ODD) to its lead product candidate, subcutaneous Marzeptacog alfa (activated), or MarzAA, for the treatment of Factor VII Deficiency (FVIID).

MarzAA is a subcutaneously administered next-generation engineered coagulation Factor VII designed for the treatment of episodic bleeding in subjects with rare bleeding disorders. FVIID is a rare condition that interferes with the blood clotting process, resulting in prolonged bleeding.

MarzAA had previously been granted ODD and fast track designation (FTD) for the treatment of another blood disorder, Hemophilia A/B, with inhibitors. Additionally, MarzAA was granted FTD for FVIID treatment by FDA prior to this ODD.

"Receiving a second orphan drug designation in addition to two FTDs for MarzAA demonstrates its potential in treating multiple rare bleeding disorders” said Nassim Usman, president and CEO of Catalyst Biosciences, in a company press release.

FDA granted orphan drug designation to Catalyst Biosciences’ MarzAA for the treatment of Factor VII Deficiency.