APR January/February 2022 - 24

» INTERVIEW
»
AN INTERVIEW WITH...
What challenges does the bio/pharma
industry face with regard to sterile fill/
finish manufacturing?
Kenneth
Laderman, PhD
Director of Manufacturing
Eurofins Advantar Laboratories, Inc.
Eurofins BioPharma Product Testing highlights how it
helps clients in the bio/pharmaceutical industry overcome
challenges in sterile fill/finish manufacturing with a state-ofthe-art
robotic vial filler solution for high value, small batches
of sterile GMP or GLP products for use in Phase I or Phase II
clinical trials.
The industry is rapidly changing with increased product
complexity such as mAb, mRNA, AAV and LNP formulations
and is pushing for shorter development and rapid turnaround
times. These changes can often introduce additional risks
and errors into the sterile fill/finish process, resulting in
production delays, additional costs, and safety concerns.
The FDA is also pushing the industry for less human
intervention in aseptic processing. Human contact with the
sterile product is the greatest risk for contamination in the
aseptic process.
The advent of personalized medicines also brings challenges to
manufacturing. The need to move from large batch production
to small lots of complex medicines, which may have a patient
population of one, will change how manufacturing and supply
chains are structured.
As many clinical hospitals lack a traditional cleanroom,
close collaboration with an established sterile fill/finish
manufacturer may become crucial. The need for speed and
flexibility pertaining to the manufacturing process could
become important to personalized medicines.
How is Eurofins BioPharma Product
Testing helping companies overcome
these challenges?
Our state-of-the-art, sterile fill/finish solution helps eliminate
human error and other associated risks when producing small
batches (up to 3000 vials) of sterile GMP or GLP products for
Toxicology Studies and Phase 1 and 2 trials. Our system fills vials
for small batches of GMP product, processing units quickly with
precise filling volumes.
The system we use is the Vanrx Microcell Vial Filler. It is a
gloveless, closed, and completely robotic system designed to
reduce human error, time, and contamination as the flow path
is single use, and disposable.
What else can you tell us about your
company's sterile fill/finish services?
We perform compounding of batches in an ISO 8 clean room
followed by ISO 5 single or dual sterile filtration using sterile,
single use, closed filtration systems with aseptic connectors.
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| January/February 2022
APR January/February 2022

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