3P Innovation Marks Significant Milestone with Delivery of First Aseptic GMP Cryovial Filling Platform
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3P Innovation, a world-class leader in automated solutions for the pharmaceutical and biotechnology industries, has announced the successful delivery of its first truly aseptic GMP cryovial filling platform.
As part of 3P Innovation’s ‘Discovery Range,’ CryoFil is designed to automate the critical process of filling cryovials with cell and gene therapy products. This ensures not only the highest levels of sterility and consistency, but also marks a significant milestone in the advancement of aseptic cryogenic processing, setting a new standard for sterility assurance in the cell and gene therapy industry.
“We are thrilled to introduce the first truly aseptic GMP cryovial filler to the market,” said Nick Brooks, Managing Director of 3P Innovation.
The CryoFil Filling Platform utilizes advanced technologies such as intelligent closed-loop filling with 100% weight verification and a low-shear pump, which minimizes cell damage and optimizes filling efficiency. It is the latest addition to 3P Innovation’s Discover Range, a portfolio of GMP-compliant equipment designed to support early-stage drug development activities in the cell and gene therapy industry.
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“This platform represents our commitment to developing innovative solutions that address the critical quality and efficiency challenges faced by the cell and gene therapy industry. By introducing this technology, we are helping to elevate sterility assurance levels and advance industry practices in contamination prevention and risk reduction,” Brooks continued.
Additionally, the CryoFil features automated cryovial placement into racks for rapid transfer to controlled rate freezers, reducing the risk of contamination, and ensuring rapid processing.
Key benefits of the CryoFil include:
- Unprecedented sterility assurance, setting a new benchmark in the industry.
- 100% in-process checks to ensure every vial is accurately filled and meets the required specifications.
- Maximized cell yield due to CryoFil’s closed loop filling system, minimizing hold-up volume and ensuring efficient filling.
- Precision and accuracy in repeatable filling with a high-precision peristaltic pump, ensuring consistent dosing and product quality.
- Compact and versatile, it can be integrated into standard BSCs or isolators, making it a flexible solution for various lab settings.
- Compliance and traceability: the system generates a comprehensive batch report, providing full traceability of the process and complying with CFR 21 Part 11 regulations.
3P Innovation has confirmed attendance at Advanced Therapies Week 2024, where the team will be on hand to discuss this announcement further. Visit the team at booth #701.
Yet to confirm your place? Book your ticket now >>
Source: 3P Innovation Press Release, via Phacilitate
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