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Figure 2
110
105
Amount (%)
100
95
90
85
Thr
Tyr
Ile
Trp
Ser
Asp
Asn
Glu
Pro
Ala
Cystine
Leu
Phe
Arg
Val
Met
Gly
Lys
His
Amino Acids
Figure 2: Amino acid homogeneity (%RSD) of IA Pin Mill batches versus batches produced via
the cGMP SSPM and CM; Key: blue-IA Pin Mill (large lot); lavender-IA Pin Mill (small lot), red-
SSPM; black-CM.
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Figure 3
115
110
105
Amount (%)
100
95
90
85
80
Media Components
Pyridoxine Riboflavin Thiamin Nicotinamide Folic Acid Vitamin B12 Zinc
Figure 3: Vitamin and trace metal homogeneity (%RSD) of IA Pin Mill batches versus batches
produced via the SSPM and CM; Key: blue-IA Pin Mill (large lot); lavender-IA Pin Mill (small lot),
red-SSPM; black-CM.
All of the components met the %RSD criteria for being Summary
homogeneously distributed throughout the IA Pin Mill media The IA Pin Mill provides an application/milestone-specific
independent of batch size. The data demonstrate that the manufacturing site for customers requiring a quick-turnaround
manufactured media formulation will contain the same prototyping manufacturing process and/or smaller lot sizes.
amounts of individual components, within the normal assay Upon evaluation of the analytical studies, it has been
variability range, regardless of being produced via the IA Pin demonstrated that the IA Pin Mill is an effective and scaleable
Mill (0.50 kg to 10 kg), cGMP Small Scale Pin Mill manufacturing option that can produce quality, homogenous
(10 kg to 100 kg) or large-scale cGMP Continuous Mill cell culture media equivalent to the large-scale Continuous Mill-
(300 kg to 4000 kg). produced media.
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