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Biopreservation Best Practices for regenerative medicine GMP manufacturing & focus on optimized biopreservation media

Cellular therapies are cell and tissue products sourced from biological materials that are employed as ‘living drugs.’ Such ‘living drugs’ require specialized biological support, namely biopreservation, to maintain optimal recovery, viability and return to function post-preservation. To achieve successful biopreservation, optimization of a multitude of parameters, including cooling/thawing rates based on the biophysics of specific cell types, the temperature of storage and transportation, as well as biopreservation media are of paramount importance.

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OTHER WHITEPAPERS

Accelerating the Biomanufacturing Revolution

whitePaper | February 11, 2022

The biomanufacturing revolution is here. Recent advancements in the field of synthetic biology have enabled significant cost reductions in foundational bioengineering unit operations such as DNA synthesis and sequencing.

Challenges and Solutions for Gene Therapy manufacturing

whitePaper | November 17, 2022

Gene therapy is the modification of specific genes in targeted cells in order to address genetic mutations that cause some of the most debilitating human conditions.

IoT To The Rescue For Biotech & Pharma Manufacturing

whitePaper | April 7, 2020

The Internet of Things (IoT) could not be timelier for biotech/pharma. With fierce cost pressures, the push for value-based outcomes, and the need for flexible manufacturing solutions, the IoT is the much-needed shot in the arm to bring about transformational change. Sensors, actuators, and devices (“things”) embedded in production equipment and networked through computer systems can generate an enormous amount of data. The data can be mined for insights and opportunities to drive production efficiency, automate monitoring and controlling functions, and enable flexible manufacturing systems.

Biotech Talent Management

whitePaper | February 2, 2022

While many sectors were dealt a severe blow by the COVID-19pandemic, biotech and medtech saw continued growth andare thus attracting top candidates even for non-scientific roles.

Biocontamination control in pharmaceutical production

whitePaper | November 11, 2022

Biocontamination refers to biological contamination of products by bacteria and/or fungi, as well as the toxic by-products of these microorganisms, such as endotoxin and mycotoxins from Gram-negative bacteria and fungi, respectively.

Long-term follow-up studies of cell and gene therapies

whitePaper | September 29, 2022

The market is experiencing a surge in the availability of cell and gene therapies (CGTs); it’s estimated that by 2025 as many as 20 will be introduced into the US each year.1,2