Introducing the Clara System for clarity in biologics preparations

Povair Sciences Ltd (PSL) has announced new insights into the rapidly expanding biotherapeutics market and has highlighted a critical bottleneck affecting monoclonal antibody development and automated molecule discovery workflows.

Since FDA approval of the use of recombinant insulin (the first biopharmaceutical) in 1982, adoption of biological therapeutics has continued to grow to a market now estimated to be worth over $1.5T. The high specificity and activity of this class of therapeutics, coupled with reduced side effects compared with small synthetic molecules, is continuing to drive growth.

Biomolecules approved for use in the treatment and prevention of human disease include vaccines, cell and gene therapies, hormones, enzymes, cytokines and antibodies. Monoclonal antibodies (mAbs) are one of the fastest growing categories of biotherapeutics with more than 80 approved by the FDA in 2024.

The current bottleneck for mAb development and acceleration of molecule discovery through automation is consumables, particularly at the 30–50 mL scale. The Clara™ filter plate system provides a fast and efficient solution for this challenge.

Discovery and development of large complex biomolecules requires biotechnological workflows distinct from the chemical synthesis processes used to produce small molecule therapeutics. Instruments and consumables for the development and scale up of biologics such as mAbs has not kept pace with the growth of the industry – until now.

PSL’s Clara™ 6 Well Filter plate set is uniquely designed for filtration and isolation of antibodies from up to 50 mL of culture. Developed with simple sample handling in mind the Clara™ system combines PSL’s expertise in porous materials, filters and membranes for biological applications with their plate moulding experience, enabling creation of solutions for rapidly scalable and automatable workflows.

The multi-layered Clara™ filter plates enable quick and easy separation of proteins from cellular debris and unwanted molecules produced during expression of proteins from bacterial, mammalian, plant, or yeast cell culture. Manufactured from virgin polystyrene with high optical clarity, the system allows easy observation of sample suspension flow and progress monitoring.

The Clara™ system is fully compatible with vacuum and positive pressure manifold systems, including Tecan’s Resolvex A200 XT, for rapid processing in cell clarification or protein purification applications. Designed for performance, filter plates contain porous frits and 0.45 and 0.22 µm PVDF membranes to prefilter large molecules and remove contaminating bacteria in one quick and easy step.

Fully customisable filter options are available and wells can be packed with a variety of purification resins. The filter matrix is supported by carefully engineered well base geometry, ensuring secure membrane positioning throughout the filtration process. Additional pre-filtration can be accomplished using the rigid top filter frit and optionally packed with resin, such as the diatomaceous earth typically used for CHO and HEK cell clarification.

The Clara™ 6 well filter plate set includes a receiver plate with conical well bottom for maximum sample recovery, ideal for working with challenging molecules such as bispecifics and multispecifics with low expression levels. Tailored for efficiency, the Clara™ 6 well filter plate stacks securely onto its receiver plate whether handled manually or by robotic handling systems. Fully automation compatible, with dual grip point design, all Clara™ plates conform to ANSI/SLAS standards and are available with barcoding for automated sample tracking and traceability.

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