Newsletter_12-2022_EN

www.reinraum.de
NEWSLETTER
www.cleanroom-online.com Edition EN 12-2022 | Page 20/42
Cellefill, a new integrated
solution to fast-track cell,
gene and biological therapies
Aseptic fill/finish experts Flexicon Liquid Filling, part of Watson-Marlow
Fluid Technology Solutions (WMFTS), and barrier technology specialists
Franz Ziel GmbH, today announce the launch of Cellefill- a
turnkey, vial fill/finish system with an integrated barrier solution.
Enhancing good manufacturing practice (GMP), customer compliance
and efficient aseptic manufacturing is essential as new advanced
therapy medicinal products (ATMPs), including cell, gene and biological
products advance through clinical trials to commercialisation.
To meet these new requirements, Cellefill integrates the features
of Flexicon’s FPC60 aseptic vial filling machine with barrier technologies
from Franz Ziel. Cellefill’s process design includes use of asepticsu
single-use-systems (SUS) and pre-sterilised ready to use (RTU)
product containers that enter the Grade A filling zone by a No Touch
Transfer (NTT) debagging system. Cellefill is a GMP compliant solution
that delivers enhanced levels of process flexibility to accelerate production
of ATMPs and biological therapies.
The emerging role of personalised medicine in ATMPs and biological
therapies has led to a shift in how manufacturers approach batch
production methods. Biopharmaceutical companies are increasingly
looking for ways to manufacture the smaller batches needed for patient-specific
medicines, in a way that is cost-effective to produce and
validate.
Meeting these customer needs, Cellefill maximises production
efficiency with features including recipe driven, remote set-up, zero
waste start-up and no format parts for the entire vial range.
Steve Adams, Product Manager for Cellefill at WMFTS, says:
“Through process flexibility, Cellefill enables the scale out and process
repeatability our customers need to assure product quality at all levels
of manufacturing. Providing expert guidance and support through a
single point of contact, we are a committed project partner to biopharmaceutical
companies at the cutting-edge of personalised medicine.
„The challenge for the industry is to produce these new therapies
quickly, safely and cost efficiently, with a system that can be rapidly
changed over between batch or different small batch medicines.”
Designed to suit various filling requirements and class cleanrooms,
the Cellefill solution is available in three models with different
barrier technologies. Each model delivers enhanced levels of process
and quality assurance with highly accurate peristaltic pump performance,
integrated barrier and environmental monitoring.
Cellefill builds on the partners’ experience in providing technology
and extensive support through validation, qualification and operator
training to facilitate a smooth transition into GMP compliant and
cost-effective manufacturing.
Markus Horsch, division manager sales and marketing from Franz
Ziel says: “Cellefill is a fully integrated vial fill/finish and barrier technology
solution supporting enhanced levels of product quality and
sterility assurance to mitigate risks of contamination. Cellefill adopts
pre-designed and configurable modules to reduce project time and
fast track therapies to market.
„Cellefill minimises batch changeover time with enhanced cleanability,
rapid Vapour-phase Hydrogen Peroxide (VHP) cycle times and
gloveless operation in the aseptic core, while retaining the possibility
of risk-based compliant interventions if needed in rare incidences to
prevent batch loss.”
The Cellefill solution enables a streamlined project timeline with
integrated technical and GMP documentation to increase efficiency
of the project validation and qualification stages.
The modularity, flexibility, scale out capabilities and efficiencies
establish Cellefill as a next generation vial fill/finish solution for new
ATMP and biologic products as they advance through clinical trials to
commercialisation.
Watson-Marlow GmbH
D 41569 Rommerskirchen