NEWARK, Calif.--(BUSINESS WIRE)--ATUM, a California-based bioengineering company, today announced the launch of its Good Manufacturing Practices (cGMP)-compliant Master Cell Banking production services. This new capability enables ATUM to provide an end-to-end cell line development solution, from DNA design through Master Cell Bank (MCB) and Working Cell Bank (WCB) release, supporting Investigational New Drug (IND) applications.
“ATUM is pleased to add fully integrated cGMP-compliant cell banking to our market-leading cell line development platform,” said Jeremy Minshull, PhD, Chief Executive Officer at ATUM. “Our goal is to provide our global base of customers with a streamlined process to fully support their regulatory filings.”
ATUM’s California-based facility provides uninterrupted operation and offers cell banking from CHO-derived cell lines. The facility comprises a dedicated ISO 7 and ISO 8-classified manufacturing suite with multiple qualified ISO 5-classified working spaces with controlled access. Every customer project is managed under the industry guidelines for 21CFR Parts 210 and 211/1271, ISO 14644-1, ICH Q5D and ICH Q7.
“This is an exciting new development for ATUM that builds on the success of our Leap-In Transposase platform and is an important step in our evolution as a leading provider of regulatory-grade services to the global biotechnology industry,” said Claes Gustafsson, PhD Chief Commercial Officer at ATUM. “Our facilities are fully compliant with GMP standards and are managed by a growing team of quality assurance experts who monitor operations and each client’s unique requirements.”
ATUM’s Leap-In Transposase platform complements the new cell banking solutions and enables rapid, robust, and efficient manufacturing of high-quality protein pharmaceuticals. The Leap-In platform has already been licensed by the majority of the global top 20 pharmaceutical companies and to date has enabled 16 IND applications to be filed and approved by regulatory authorities in three jurisdictions, with many more approvals expected within the next few months.
About ATUM
ATUM offers an integrated pipeline of tools including gene design, optimization and synthesis, expression vectors, and platforms for protein and cellular engineering and production. The company exploits the dependence of biological activity on well-designed sequences. ATUM’s tools and solutions are fueling the transformation of biology from a discovery science to an engineering discipline. By collaborating with our clients, ATUM accelerates breakthroughs and moves research further faster. For more information please visit: www.atum.bio.
