ATUM Launches cGMP Compliant Master Cell Bank Production Services

0

NEWARK, Calif.–(BUSINESS WIRE)–ATUM, a California-based bioengineering company, today announced the launch of its Master Cell Banking Good Manufacturing Practices (cGMP) production services. This new capability enables ATUM to provide an end-to-end cell line development solution, from DNA design to Master Cell Bank (MCB) and Working Cell Bank (WCB) release. , supporting Investigational New Drug (IND) applications.

“ATUM is excited to add a fully integrated, GMP-compliant cell bank to its market-leading cell line development platform,” said Jeremy Minshull, PhD, CEO of ATUM. “Our goal is to provide our global client base with a streamlined process to fully support their regulatory filings.”

ATUM’s California facility provides uninterrupted operation and offers cell banks from CHO-derived cell lines. The facility includes a dedicated ISO 7 and ISO 8 rated manufacturing suite with multiple qualified ISO 5 rated workspaces with controlled access. Each client project is managed according to 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 for the global industry. of biotechnology,” said Claes Gustafsson, PhD. Commercial Director at ATUM. “Our facilities are fully GMP compliant and are managed by a growing team of quality assurance experts who monitor each customer’s unique operations and requirements.”

ATUM’s Leap-In Transposase platform complements novel cell banking solutions and enables fast, robust and efficient manufacturing of high-quality protein pharmaceuticals. The Leap-In platform has already been cleared by the majority of the top 20 global pharmaceutical companies and has to date resulted in 16 IND applications being filed and approved by regulatory authorities in three jurisdictions, and numerous other approvals are expected in the coming 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 customers, ATUM accelerates breakthroughs and moves research forward faster. For more information, visit: www.atum.bio.

Share.

About Author

Comments are closed.