TOYOPEARL GigaCap^® Cation Exchange Resins for Aggregate Removal from Monoclonal Antibodies
Tosoh Bioscience LLC
Aggregate removal is a pivotal process step in the purification of monoclonal antibodies (mAbs). The removal of soluble, non-precipitated mAb aggregates is highly challenging due to their physical and chemical similarity to the drug product itself. Ion exchange chromatography (IEC) has long been used as an effective means of removing process impurities from biological drug products. Cation exchange chromatography (CEX), in particular, has shown to be effective in separating mAb monomer from dimers and higher-order aggregates. In the following paper, the removal of mAb dimer and higher-order aggregates from mAb monomer using TOYOPEARL GigaCap cation exchange resins is demonstrated.

PEGylated Protein Analysis by Size-Exclusion and Reversed-Phase UPLC
Stephan Koza and Kenneth J. Fountain; Waters
The first PEGylated biotherapeutic, pegademase, which is a bioconjugate of the bovine derived enzyme adenosine deaminase and 5 KDa molecular weight (MW) polyethylene glycol (PEG), was introduced in 1990. Pegademase is used for the treatment of individuals with severe combined immunodeficiency disease (SCID).

Mammalian Virus Purification Using Ceramic Hydroxyapatite
Yae Kurosawa, Malko Saito, Daniel Yoshikawa, and Mark Snyder; Bio-Rad
Conventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.

Efficient, high-titer monoclonal antibody production in a fed-batch process using single-use stirred-tank and rocking bioreactor systems
Olof Larsson, Eric Fäldt, Thomas Falkman, Andreas Castan, and Cecilia Anneren; GE Healthcare
MAb production in fed-batch processes with single-use Xcellerex™ XDR-200 stirred-tank and ReadyToProcess WAVE™ 25 rocking bioreactor systems. Cell expansion was performed in a 15 L rocking bioreactor culture to seed a 200 L stirred-tank bioreactor culture.

Analysis and Control of Particles in Biopharmaceuticals
Dr. Tara Sanderson; SGS Life Science Services
A key challenge for companies developing biologics is the control of particles in the final formulation. Managing product contamination from intrinsic and extrinsic particles, and protecting patients from the associated risk, is increasingly important.

Minimizing Excipient Fluorescence Interference Using Handheld Raman
Dr. Claire Dentinger; Rigaku Raman Technologies
A study of commonly used pharmaceutical excipients concluded that 1064nm handheld Raman overcomes sample generated fluorescence, thus providing compound specific “signature” Raman peaks for more accurate identification.

More Efficiency with Equivalent Data: MFI 5200
ProteinSimple
Micro-Flow Imaging (MFI) is now the go-to technology for monitoring and characterizing a wide range of visible and subvisible particles and protein aggregates using particle size and morphology. This application note shows how the latest MFI system stacks up to its predecessor by cutting the hands-on time for sample analysis without any loss in functionality and performance.