Pharmaceutical Technology Editors

Aizon, an artificial intelligence and advanced analytics platform company, announced the launch of its good practice compliant data processing product, Aizon Digitize (AD), on June 21, 2022. AD converts data from paper to data with the goal of increasing productivity and avoiding time-consuming, error-prone manual data inputs.

According to a company press release, the product automatically uploads paper records and commonly used file formations to begin the creation of an audit trail; it then immediately enables tracking of changes to the data. It is designed for integration with electronic batch records, laboratory information management systems, quality management systems, and manufacturing execution systems.

“Many pharmaceutical manufacturers still rely on manual entries and processes to perform critical tasks. This very common approach exponentially increases the risk of introducing errors and hindering their ability to optimize the entire development and manufacturing process,” said John Vitalie, CEO, Aizon, in the press release. “[AD] helps [users] avoid unnecessary manual entry and transfer of information which can create volumes of erroneous data resulting in increasing levels of risk. By shifting the manual workload to an automated digital process, our customers can leverage all of the valuable data trapped in paper-based records and spreadsheets. This is the on-ramp to realizing the benefits that compliant Pharma 4.0 technology can bring to any biopharma manufacturing operation.”

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Aizon Digitize is designed to help life science manufacturers transition data from paper to digital.

Aizon Launches GxP Compliant Data Processing Solution

YewMaker and Connect in Pharma have announced that the winners of the new Sustainable Medicines Packaging Award will be announced at an in-person awards ceremony at the Connect in Pharma event in Geneva on Sept. 14, 2022.

The new awards are run by YewMaker, a sustainable healthcare company. The awards will highlight and celebrate sustainable innovations in pharmaceutical packaging under two categories with a gold, silver, and bronze award in each. The two categories will focus on design and processes that reduce the overall impact on the environment.

“Collaboration and innovation are essential to delivering the changes needed to make sustainability core to how pharmaceutical packaging is designed and used,” said Nazneen Rahman, founder and CEO of YewMaker, in a press release. “By announcing the winners of these new awards at the Connect in Pharma conference this September, we can bring a sharper focus on sustainability innovations in the pharmaceutical industry.”

“We are very excited to be partnering with YewMaker to host these important awards at Connect in Pharma in Geneva,” added Renan Joel, divisional director at Connect in Pharma, in the release. “Connect in Pharma is designed to focus on innovation and technology in the pharma and biotech community, and sustainable medicine packaging design is an important area of innovation in the sector. We are delighted to be coupling innovation with sustainability while putting the future of the planet in the spotlight.”

Connect in Pharma will host an awards ceremony to showcase innovations in sustainable pharmaceutical packaging. 

Sustainable Medicines Packaging Award Winners to be Announced at Connect in Pharma

The European Medicines Agency (EMA) has begun a rolling review of the Spikevax vaccine that has been adapted to protect against two variant strains of SARS-CoV-2, the agency announced on June 17, 2022. The review will focus on non-clinical laboratory study data as well as chemistry, manufacturing, and controls (CMC) data relating to the manufacturing of the vaccine. A rolling review allows the agency to begin assessing available data before marketing approval of the vaccine. The agency will review additional data from the sponsor company as it is received.

rolling review of an adapted Comirnaty COVID-19 vaccine 

on June 15, 2022. “The details about the adapted vaccine, for example whether it will specifically target one or more SARS-CoV-2 variants or subvariants, are not yet defined. However, EMA’s review will initially focus on CMC data for the component targeting Omicron subvariants,” the agency stated in a press release.

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

EMA Starts Rolling Review of Adapted COVID-19 Vaccines

An International Coalition of Medicines Regulatory Authorities (ICMRA) workshop, held on May 20, 2022 and co-chaired by Health Canada and the European Medicines Agency (EMA), highlighted lessons learned during the COVID-19 pandemic about the international collaboration on observational research. According to EMA, real-world evidence gathered from observational research assists regulators to understand the safety and effectiveness of medicines used in clinical practice.

Results from three technical ICMRA working groups that focus on vaccines, pregnancy observational research, and building international cohorts of patients were discussed in the workshop. Workshop participants agreed these platforms allowed for timely sharing of data, expertise, and tools.

Experience learned during the performance of observational studies based on COVID-19 real-world data was shared by the participants. It was agreed upon that rapid generation of evidence gained from active interactions between regulators, researchers, and academia is crucial for regulatory decision making in times public health crises.

Participants in the workshop included representatives from the World Health Organization and more than 28 medicines regulatory authorities. The findings from the workshop can be found on the 

Lessons learned from the COVID-19 pandemic about the benefits of international collaboration were discussed in a May 2022 workshop.

International Collaboration on Pharmaceutical Regulations 

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.”

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

Orbit Discovery, a biopharmaceutical company focused on discovering candidate peptide therapeutics, announced on June 13, 2022 that it had been awarded a National Science and Mathematics Access to Retain Talent (SMART) Grant by Innovate UK, the United Kingdom’s innovation agency. Totaling £472,000 ($498,000 USD), the grant is intended to facilitate the implementation of droplet-based microfluidics for cell-based functional screening and expand the capabilities and throughput of Orbit’s peptide display platform.

The goal of Orbit’s project is to advance the discovery of peptide therapeutic candidates by improving overall process efficiency and reducing risk and associated cost. In this vein, according to a company press release, the grant funds will go toward validating the microfluidic components of Orbit’s peptide discovery platform, a next-generation microfluidic-based functional screen designed to interrogate millions of peptides in cell-based assays.

The platform is being built to directly address difficult-to-access drug targets, in particular multi-membrane spanning proteins like G-protein-coupled receptors. It aims to rapidly identify molecules that generate a therapeutically relevant functional response earlier in the drug discovery process. This will avoid polluting screening outputs with non-functional binders, as is often observed with other platforms.

“This Innovate UK [SMART] Grant will help us further cement our technical leadership in functional screening,” said Anthony Pitt, chief technology officer, Orbit Discovery, in the press release. “The microfluidic platform can elevate our current functional screening capabilities from tens of thousands to millions of peptides. This throughput will help us identify rare functional binders that are typically missed with more traditional screening platforms.”

Orbit Discovery has been awarded the Innovate UK Grant to expand high throughput cell-based functional screening platform capabilities in peptide drug discovery.