Mammalian cells have been used to produce therapeutic recombinant proteins for over thirty years and during that time there has been significant advances in the technologies and methods used to engineer the cell lines and to characterize and ensure product safety and efficacy of the products they produce. Regulators have also gained considerable experience in establishing guidelines and standards for the industry. Of note, the assurance of “clonality” of the mammalian cell line to prove that the cell line has been cloned from a single cell progenitor, is of major importance. Without it, companies must execute additional studies of the cell line and product to further ensure the product’s purity and homogeneity, which can add significant cost and delay the delivery of these therapies to patients.

Fortunately, technology providers have risen to the challenge to help provide the evidence of cell line clonality required for IND submission. Advanced Instruments recently announced the launch of the GMP-compliant Solentim VIPS PRO system. Based on the original VIPS technology, VIPS PRO is a high efficiency single cell seeder equipped with industry-leading imaging technology capable of providing the definitive proof of monoclonality regulators expect. This overcomes bottlenecks in cell line development (CLD) workflows to enable rapid advancement of new biotherapeutics to market.

Highlighted features include:

• Optimized high-efficiency gentle single cell seeding
• Double-Lock image-based clonal assurance
• Intelligent cell recognition powered by artificial intelligence (AI)
• GMP-certified, single-use cell reservoir
• Full integration with STUDIUS™ data management and decision-making software (ensures 21 CFR Part 11 compliance)
• Compact and ergonomic instrument design

The optimally designed VIPS PRO transforms CLD workflows by combining powerful single cell seeding technology with two-step, image-based, Double-Lock Assurance of clonality. The proprietary AI-driven algorithm detects high-value cells with stunning accuracy and precision. It is simple to produce high-quality, image-based verification of clonality, including imaging of droplets and whole wells from day 0 to outgrowth.

Compared to manual methods, VIPS PRO eliminates human error, reduces hands-on time, and compresses timelines for process development and clinical manufacturing. Gamma-irradiated Single-use Seeding Kits are the first GMP-certified consumables on the market helping to simplify and accelerate the seeding process while eliminating the possibility of sample carryover and contamination between projects.

The VIPS PRO is controlled by the fully integrated STUDIUS software platform, which provides security features and a complete audit trail to comply with 21 CFR Part 11.  It also delivers advanced data analysis and management for error reduction and complete sample tracking which enables seamless adoption into GMP workflows. Furthermore, leveraging the integration of STUDIUS with the Solentim portfolio including ICON (for productivity measurement) and Cell Metric (clonal outgrowth) enable seamless data integration for effortless triaging and faster-than-ever decision making.

Experience confirmation of clonality, high-quality imaging, intelligent data management, and GMP-certified features—all in one ergonomically designed and space-saving instrument. For more information on the VIPS PRO, please visit: https://www.aicompanies.com/single-cell-seeder/vips-pro/