APR January/February 2022 - 26

» INTERVIEW
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filtration, in-process testing is needed. The bag is then transferred to
the Microcell where it is connected to the fill needle flow path using an
aseptic connection.
The Microcell is loaded with ready-to-use vials and caps. The door is
closed and will not be opened until the product is filled and capped.
The system then performs a pressure leak test to ensure it is sealed.
Once confirmed, the system begins a validated vapor phase hydrogen
peroxide (VPHP) decontamination cycle. After the peroxide is removed
by evaporation, the Microcell performs a fill weight check and then
proceeds to filling. It automatically fills and caps the 300 vials loaded
into the system. Once capped, the door is opened and the vials
removed. Another set of 300 vials and caps are loaded followed by a
pressure check and VPHP decontamination. This cycle repeats 10 times
to fill 3000 vials. At the end of the fills, the Microcell generates a fill
report that is attached to the Batch Record.
What are the benefits of working with
Eurofins for early phase sterile fill/finish
manufacturing?
Because our manufacturing facility located in San Diego, CA, is a small
site with a wealth of experience in manufacturing with qualified QC
personnel, we can complete sterile fill finish projects in less time than
other CMOs or CDMOs.
Upon project initiation, we will immediately begin drafting testing
and specification documents needed to release the drug substance
and critical excipients. Our state-of-the-art QC lab can handle
any drug substance from small molecules to complex mRNAs.
Once documents are approved and methods qualified, we move
immediately
to releasing the drug substance (no wasted time
shipping materials to other analytical sites for testing). Additionally,
we stock pre-qualified sterilizing filters, ready -to-use vials, stoppers,
and caps- with no time lost! While raw material release is going on,
we will be tailoring a master batch record based on the information
we have gathered from the client. With the materials released and
the master batch record approved, we move immediately into filling
the product. Other advantages in working with Eurofins BioPharma
Product Testing include:
* Minimal product loss as dead volumes are very low.
* Press-fit closures sealed within the isolator significantly
reduces particles.
* Isolator technology and robotics eliminate human interaction
with the sterilized product.
* Single-use flow paths reduce the scope of cleaning.
* RTU vials eliminates the need for washers, autoclaves, and
depyrogenators.
* Reduced tech transfer requirements and shorter
project timelines.
What's the lead-time for sterile filling at
Eurofins BioPharma Product Testing?
Currently, our lead-time is very favorable at four to six weeks to start a
new project. Because the Microcell fill line was designed to use 100%
single use components, we can rapidly turnover the suite. Minimal time
is needed for complete cleaning between manufacturing campaigns.
How can our readers learn more about
Eurofins BioPharma Product Testing's sterile
fill/finish services?
You can learn more about our sterile fill/finish support on our web site:
Eurofins.com/BPT or e-mail us at pharma@eurofins.com
We also hosted a webinar on this topic earlier this year and a recording
is available on our website: www.Eurofins.com/bptwebinars
26 |
| January/February 2022
http://www.Eurofins.com/BPT http://www.Eurofins.com/bptwebinars

APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022

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