Video

Robust Workflow For Single Cell Cloning Of iPSCs For Making cGMP Master Cell Banks

Advanced Instruments presents a platform combination of Solentim instrumentation (the VIPS™) and soluble matrix (MatriClone™, based on laminin) for the high-efficiency, high-viability single-cell cloning of iPSCs to form the Master Cell Bank. This includes an industry-leading clonality documentation package to support future investigational new drugs (INDs).

Most current instrumentation for stem cell isolation and cloning is only suitable for use in a research environment. Advanced Instruments realizes the need for cell therapy customers to implement systems in research now which can then be replicated and used in their clinical manufacturing. Therefore, Advanced Instruments aims to ensure all Solentim equipment is supplied in line with global cGMP requirements. That said, their equipment is fully validated according to cGMP and specific GAMP 5 principles and regulatory requirements for computerized systems, such as 21 CFR (Code of Federal Regulations) part 11 and EudraLex Volume 4, Annex 11. This is deemed as essential for customers planning to adopt this approach in their GMP manufacturing environment.

VIEW THE VIDEO!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Cell & Gene? Subscribe today.

Subscribe to Cell & Gene X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Cell & Gene