Data integrity (DI) reaffirms the pharmaceutical industry's commitment to manufacture drugs
that are safe, effective and fulfil quality standards. At the same time, DI is a crucial tool for …

Continuous manufacturing (CM) has the potential to provide pharmaceutical products with
better quality, improved yield and with reduced cost and time. Moreover, ease of scale-up …

We demonstrate the application of molecular rotational resonance (MRR) spectroscopy to
quantify regioisomeric, dehalogenated, and enantiomeric impurities in two raw materials …

The development of generic preparations that are bioequivalent to a reference listed drug
(RLD) is faced with challenges because some critical attributes of RLDs are commonly …

Purpose This study describes the first efforts to build a spectral library to identify four cell
culture media in powder form with spectra obtained with a handheld Raman spectrometer …

Herein, the utility of Raman spectroscopy for rapid identity (ID) verification of biotherapeutic
protein products in solution is demonstrated. The success of this approach hinges on the …

This is a reflection on a career where process analytical chemistry or process analytical
technology (PAT) has always been present. It is an exception to the author's advice to …

Bacteria identification plays an essential role in preventing health complications and saving
patients' lives. The most widely used method to identify bacteria, the bacterial cultural …

The identification of the critical quality attributes (CQAs) of monoclonal antibodies (mAbs) is
a key component of quality by design. Traditional detection methods for the identification of …

The document is composed by the monograph and two internship reports: Continuous
manufacturing is the upcoming manufacturing paradigm, capable of revolutionize the way …