Monoclonal antibodies (mAbs) have established themselves as the leading biopharmaceutical therapeutic modality. The establishment of robust manufacturing platforms are key for antibody drug discovery efforts to seamlessly translate into clinical and commercial successes. Several drivers are influencing the design of mAb manufacturing processes. The advent of biosimilars is driving a desire to achieve lower cost of goods and globalize biologics manufacturing. High titers are now routinely achieved for mAbs in mammalian cell culture. These drivers have resulted in significant evolution in process platform approaches. Additionally, several new trends in bioprocessing have arisen in keeping with these needs. These include the consideration of alternative expression systems, continuous biomanufacturing and non-chromatographic separation formats. This paper discusses these drivers in the context of the kinds of changes they are driving in mAb production processes.

Evolving trends in mAb production processes.

Interfacial phenomena in drug delivery and targeting

Concentrated fed-batch cell culture increases manufacturing capacity without additional volumetric capacity

Continuous polyethylene glycol precipitation of recombinant antibodies: Sequential precipitation and resolubilization

Advance chromatin extraction improves capture performance of protein A affinity chromatography.

High titer (>10 g/L) monoclonal antibody (mAb) cell culture processes are typically achieved by maintaining high viable cell densities over longer culture durations. A corresponding increase in the solids and sub-micron cellular debris particle levels are also observed. This higher burden of solids (≥15%) and sub-micron particles typically exceeds the capabilities of a continuous centrifuge to effectively remove the solids without a substantial loss of product and/or the capacity of the harvest filtration train (depth filter followed by membrane filter) used to clarify the centrate. We discuss here the use of a novel and simple two-polymer flocculation method used to harvest mAb from high cell mass cell culture processes. The addition of the polycationic polymer, poly diallyldimethylammonium chloride (PDADMAC) to the cell culture broth flocculates negatively-charged cells and cellular debris via an ionic interaction mechanism. Incorporation of a non-ionic polymer such as polyethylene glycol (PEG) into the...

https://www.tandfonline.com/doi/pdf/10.1080/19420862.2015.1007824

PDADMAC flocculation of Chinese hamster ovary cells: Enabling a centrifuge-less harvest process for monoclonal antibodies

Recent advances in the productivity of industrial mammalian cell culture processes have resulted in part in increased cell density. This increase and the associated increase in cellular debris are known to challenge harvest operations, however this understanding is limited and largely qualitative. Part of the issue arises from the heterogeneous size and composition of cellular debris, which makes harvest feed stream extremely difficult to characterize. Improved characterization methods would facilitate the development of clarification approaches that are consistent and scalable. This work describes how both particle size and cholesterol analysis can be used to characterize the feed stream. Particle size analysis by focused beam reflectance and dynamic light scattering are shown to be predictive of centrate filterability under certain harvest conditions. Because of the particle size range limitations of each detector, their applicability is limited to a particular stage or method of clarification. The measurement of cholesterol present in the cell culture supernatant or centrate was successfully used in providing relative amount of lysed cellular debris and enabled us to predict clarification performance of acid precipitated harvest regardless of particle size distribution profile.

Evaluation of predictive tools for cell culture clarification performance.

La presente invention concerne un procede pour recolter des proteines recombinantes a partir d'un fluide de culture de cellules de mammifere. Le procede fait usage de polymeres cationiques, de polymeres non ioniques et d'agents tensio-actifs non ioniques.

Procédé de floculation

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PDADMAC flocculation of Chinese hamster ovary cells: Enabling a centrifuge-less harvest process for monoclonal antibodies

Evaluation of predictive tools for cell culture clarification performance.

Procédé de floculation