27 Drug Discovery, Pharmaceuticals & Cannabis Testing New virus removal fi lter enhances biopharmaceutical effi ciency
Asahi Kasei Medical announced the launch of its Planova™ FG1, a next-generation virus removal filter designed for biopharmaceutical manufacturing. Released in October 2024, the Planova™ FG1 features significantly higher flux, enhancing the efficiency and safety of biotherapeutic production processes.
The bioprocess business of Asahi Kasei Medical focuses on providing Planova™ virus removal filters, equipment, biosafety testing services, and biopharmaceutical CDMO operations. Planova™ products, sold since 1989, have continuously evolved to meet the rising global demands for viral safety in biopharmaceuticals. The product lineup expanded with the introduction of Planova™ BioEX in 2009 and Planova™ S20N in 2022. With the addition of the Planova™ FG1, the company aims to further support the growing demand for monoclonal antibodies and biopharmaceuticals, which are projected to grow at 5-10% annually.
The Planova™ FG1 is engineered for optimal productivity in biopharmaceutical manufacturing, offering rapid filtration and robust virus removal capabilities. Its high flux rate - approximately seven times greater than that of Planova™ BioEX - enables faster filtration and minimises the risk of virus breakthrough during filtration suspension. Customer evaluations during development confirmed excellent protein filtration and virus removal performance, even without a prefilter for aggregates. Additionally, Planova™ FG1 is compatible with standard cleaning-in-place (CIP) and sterilisation- in-place (SIP) processes, ensuring it integrates smoothly with a wide range of existing manufacturing equipment.
Mass production and shipments of smaller Planova™ FG1 filters began in October 2024, with plans to expand the product range to include larger filters for process scaling. This new addition to the Planova™ lineup strengthens Asahi Kasei Medical’s commitment to enhancing the productivity, safety, and efficiency of pharmaceutical manufacturing.
“We are excited to introduce the Planova™ FG1 and to continue supporting the biopharmaceutical industry with our growing portfolio of innovative solutions,” said Ken Shinomiya, President of Asahi Kasei Medical. “Our products are designed to ensure the safe, efficient manufacturing of biopharmaceuticals that patients can trust.”
More information online:
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Proactively tackling unexpected nitrosamine contamination in pharmaceuticals
In recent years, the pharmaceutical industry has faced significant challenges due to the unexpected presence of nitrosamine contaminants in various medications. The issue first emerged in 2018 when an unknown impurity was detected in batches of the blood pressure medication valsartan. This impurity was later identified as the nitrosamine NDMA. The discovery prompted a series of investigations that uncovered additional nitrosamine contamination in other drugs, including the heartburn medication ranitidine and the diabetes treatment metformin. These findings led to multi-million dollar fines and reputational damage for the companies involved. Regulatory bodies like the EMA and FDA responded by mandating comprehensive risk assessments for nitrosamine contamination in all drug products.
Initially, the focus was on well-known small-molecule nitrosamines such as NDMA. However, it soon became apparent that a wider variety of nitrosamines were present in drug products. With nitrosamines potentially forming from the active pharmaceutical ingredients themselves, identifying what to look for became an increasingly complex challenge.
Many analytical methods at the time concentrated on targeted analysis of a predetermined list of compounds. This approach, while effective for known contaminants, left room for unexpected nitrosamine groups to go undetected. These could originate from nitrosamines forming in the final product due to interactions between ingredients not previously identified as risks or from contamination during the manufacturing process. If a nitrosamine wasn’t on the testing list, there was a high chance it would remain unnoticed.
To address this issue, alternative strategies have been explored. One effective method is the Apparent Total Nitrosamine Content (ATNC) analysis. This non-targeted screening technique detects the nitrosamine functional group itself rather than specific nitrosamine molecules. By providing a single response for all nitrosamine content in a sample, ATNC analysis allows for rapid identification of potential contamination without needing to know exactly which nitrosamines are present.
Ellutia’s Automated Total Nitrosamine Analyser offers a robust solution to this challenge. It can quickly screen samples to confirm they are free of potential nitrosamine contamination down to parts- per-billion levels, without requiring standards for every specific nitrosamine. This enables users to focus detailed, specific testing only on samples that indicate possible contamination, making the testing process more efficient and comprehensive.
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ilmt.co/PL/65Z5 63482pr@reply-direct.com
Automated clone screening system accelerates biologic drug discovery
Beckman Coulter Life Sciences, a global leader in laboratory automation and innovation and a part of Danaher Corporation, has unveiled the Cydem VT Automated Clone Screening System, a high-throughput microbioreactor platform designed to revolutionize automated top clone screening for biologic drug discovery.
The Cydem VT System significantly accelerates the biologic drug development process by reducing manual steps in Cell Line Development by up to 90% in a single experiment, while eliminating the need for many traditional screening steps. This reduction in labour-intensive processes significantly shortens time to market for monoclonal antibody-based therapeutics.
By providing early insights into cell growth and productivity, the Cydem VT System offers more reliable clones and optimised cultivation conditions that closely replicate biomanufacturing production. It is particularly suited for cell line development of Chinese Hamster Ovary (CHO) cell lines used in monoclonal antibody production.
“Our Cydem VT System offers a breakthrough in expediting critical research therapies for diseases like autoimmune conditions and cancer,” said Dr Sebastian Hofzumahaus, Product Manager. “We understood the challenges of selecting productive clones and developed a solution that confidently identifies the best clones, streamlining the process and reducing the risk of poor clones. By providing earlier answers and improved cultivation conditions, the Cydem VT System accelerates the path to discovering the next medical breakthrough.”
Integrating Beckman Coulter Life Sciences’ trusted technologies, the system combines microbioreactor capabilities, liquid handling, antibody titre, and cell health measurements into a single advanced platform. It enables parallel pH-controlled, fed-batch cultivation and monitoring of up to 96 bioreactors with individual gassing. Automated operations offer at least three days of walk- away time, while online, non-invasive pH, dissolved oxygen (DO), and biomass measurements ensure precise control over critical cultivation parameters. On-deck determination of cell concentration, viability, and titre concentration enables confident selection of the best clones.
More information online:
ilmt.co/PL/O3q1 63792pr@reply-direct.com
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