FILL FILTRATION

Automated aseptic fluid management and precise cold chain control significantly enhance drug substance manufacturing. Despite their differences, all drug substances share a critical need for control and reproducibility. cGMP-compliant single-use technologies facilitate standardization in crucial process steps, addressing a significant technology gap in biopharmaceutical production.

By minimizing product loss during single-use bioprocess container handling and utilizing highly accurate automated filtration and aliquotation, along with controlled freezing and thawing, these technologies elevate bioprocessing across all modalities. The result is improved cost-effectiveness, superior drug product quality, faster performance, and unlimited scalability.

MONOCLONAL ANTIBODY (mAbs)

Controlled processes are essential for the manufacturing of monoclonal antibodies (mAbs). These antibodies require meticulous care and delicate handling throughout development, production, and logistics to maintain their effectiveness. Additionally, precisely controlled freezing and thawing rates can significantly enhance quality and lead to superior results.

Single-use technologies offer exceptional flexibility and scalability, making them the ideal solution for processing antibodies, cells, and genes across various volumes.

The expanding range of therapies and compounds necessitates adaptable plants and systems that can keep pace with rapid development and production, as well as evolving requirements. For monoclonal antibodies, special attention must be given to viscosity: due to protein-protein interactions, concentrated mAb solutions can become highly viscous, presenting challenges during the manufacturing process.

CELL THERAPY

Cell therapies have transformed the medical landscape, offering new hope for diseases once considered incurable. With numerous treatment approaches already discovered and many more emerging through ongoing clinical trials, cell therapies present boundless opportunities within the healthcare sector.

UniQTainerr™ is at the forefront of innovation, providing a comprehensive range of single-use solutions for cell therapy. Our portfolio covers every step of the manufacturing process, from primary packaging and fluid management to ultra-cold and cryogenic freezing, storage, and shipping, all designed to meet stringent regulatory requirements such as those set by the FDA.

GENE THERAPY

Gene therapy, which involves modifying a patient's genome by integrating and activating new genetic material or deactivating disease-causing or faulty genes via a viral carrier, has set groundbreaking milestones in treating a range of diseases, including rare ones. Despite the increasing experience in application beyond clinical trials, gene therapies will continue to demand the utmost precision and care.

UniQTainerr™ offers biotechnology companies specialized single-use solutions tailored for gene therapies, optimizing the manufacturing processes of advanced therapies (ATMPs). Our solutions encompass sterile single-use systems, customizable liquid management, and advanced freezing and storage options, ensuring the highest standards in gene therapy production.

CELL BANKING

Cells are crucial in developing new drug compounds, and their handling, such as cell banking, demands meticulous and swift processes to ensure the highest quality.

For cryopreserving cells, achieving a high recovery rate and optimal viability post-thawing is essential. Controlled, cGMP-compliant, and scalable freezing ensures reproducible processes and facilitates standardization. Studies have shown that using single-use bioprocess containers for cell cryopreservation consistently results in a high ratio of live cell recovery, thereby speeding up cell-based workflows.

Cutting-edge single-use technologies significantly enhance fluid and cold chain management for cells. Advanced solutions streamline the process of aliquoting and freezing cells to under an hour while maintaining precise control during automated aseptic dispensing and controlled cryogenic freezing with liquid nitrogen at temperatures as low as -180°C (-292°F).

ASEPTIC FILING

Drug Substance (DS) & Drug Products (DP)

Aseptic filling of drug substances (DS) and drug products (DP) is the preferred method for pharmaceutical manufacturing. It has been observed that more than half of CMOs and Biopharma manufacturers still utilize manual filling processes, which can heighten the risk of human error. Automated filling systems are known for their efficiency and accuracy, thereby decreasing the likelihood of process deviations and operational errors.

UniQTainerr bags are tailor-made for aseptic filling procedures, providing customized solutions and troubleshooting for individual requirements. Our team is committed to offering comprehensive solutions for the storage, shipping, and freezing of various drug substances and products within a wide temperature range of -180°C to +50°C (-292°F to +122°F). Through the integration of cutting-edge single-use technologies, UniQTainerr is spearheading advancements in bioprocessing and fluid management.