ADVANCES IN RAW MATERIAL CHARACTERIZATION
With the large number of raw materials that are used in typical biotech processes, characterization of raw materials requires
use of advanced analytical tools in combination with chemometrics. In this section we review some of the approaches that have
been proposed in the literature:
1. Proteomic analysis has been proposed as a tool for assessing complex raw materials such as the fetal bovine serum.9 Proteomic techniques were used to understand the lot-to-lot variability with respect to impact on growth properties of the
cell culture process. A time course study was performed to monitor specific changes in the fermentation medium.
2. An approach for routine testing of packed raw materials used in pharmaceutical processes has been recently proposed.10 The chemometrics-based approach consists of three steps. First, the initial calibration objects are divided into two classes
using a global principal components analysis (PCA) model. Next, two separate PCA models are constructed. Finally, soft independent
modeling by class analogy (SIMCA) is applied for calculating acceptance area. The approach was successfully used to analyze
fourier transform-near infrared (FT-NIR) spectra of taurine samples.
3. In a recent publication, a combined approach of near-infrared (NIR) spectroscopy and chemometrics for screening of lots
of basal medium powders based on their impact on process performance and product attributes has been proposed.11 A combined NIR and chemometrics approach was able to finger print the raw materials to distinguish between good and poor
performing media lots.
4. A recent book chapter described a number of upcoming analytical techniques, including high performance liquid chromatography
(HPLC), nuclear magnetic resonance (NMR), inductively coupled plasma- mass spectrometry (ICP-MS), and liquid chromatography–mass
spectrometry (LC-MS) and described experience managing these methods and results as part of a retrospective investigation.12 A case study also was presented using NMR as an analytical tool and PCA for analyzing data for characterizing raw materials
for a cell culture step.
With the above mentioned advances in characterization of raw materials, it is possible to fingerprint critical raw materials
and ensure that only those lots that have acceptable quality are used.
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