Storage and shipping variables may significantly impact cryopreserved product quality. In this particular article, the focus is on temperature control issues. The AATB (American Association of Tissue Banks) Standards for Tissue Banking state that cryopreserved cardiac allografts shall be maintained at temperatures of –100°C or colder. Heart valves are usually stored below –135°C in vapor phase nitrogen. There have been few published studies of higher (warmer) storage temperatures. Most heart valves are transported using dry shippers that maintain vapor phase nitrogen temperatures. These containment devices are expensive, and the costs for two-way shipping are significant due to their size and weight. Considerable savings could be had if dry ice shippers with temperature excursions warmer than the AATB standard (of up to –70°C) could be employed…
BioProcessing Journal Posts
Building a MAb bioprocessing plant is a process which normally takes three years. Before starting the engineering work, a “locked” process is necessary. This means that all the steps have to be defined by volume, time, material balances and product yield. These calculations are based on the results obtained during process development. The titer and yield of functional, recoverable product determines the plant size. Optimal volumetric productivity [g/(liter reactor volume * day)] is of utmost importance. The main difference between fed batch and perfusion culture is that in the fed batch, a centrifuge is required for cell removal, whereas in perfusion culture, cell removal is performed by dead end filtration. This is possible because the majority of the cells are immobilised on the microcarriers, thus minimizing the burden on the clarification unit…
Today, many if not all of the major pharmaceutical companies have specific budgets for large research and development pipelines for new biologics including vaccines, monoclonal antibodies, recombinant proteins and even gene therapy projects. In addition, small innovative companies are continually presenting us with novel treatment opportunities which hold great promise for the future. The reason for such huge optimism in the field of biologics is that there are now a number of “blockbuster” drugs for which the safety profile has been very successfully managed. This success has been achieved following a considerable amount of time and financial investment by both the innovators and the regulators…
Membrane proteins such as hERG (human Ether-a-go-go Related Gene) and GPCRs (G-protein-coupled receptors) have been widely used as favorite targets for discovery of therapeutic drugs to treat cardiac arrhythmia, diabetes, epilepsy, cancer, glaucoma and many other indications. They are also widely used in cell-based assays to test new pharmaceuticals for safety in the early stages of drug discovery…
In order to move product development forward, the majority of biotech companies and academic institutions involved in cell-based therapies need new facilities in order to scale up production capabilities and comply with evolving regulatory requirements. Some institutions choose to use a contract manufacturing organization (CMO) to benefit from established expertise while others support their clinical development programs with their own dedicated production facility. The main challenges in establishing a dedicated pilot-scale production facility are described hereafter…
As scientific research has become more sophisticated, the field of bioinformatics — where computer technology and biology meet — has become increasingly critical to our understanding of the natural world. Entire databases of biological data are created, indexed, organized, and analyzed, requiring sophisticated and robust tools. Bioinformatics often make use of mathematical computations, algorithms, artificial intelligence, modeling, and other complex applications…
The biopharmaceutical industry has seen a major shift away from the use of serum and other animal-derived components in the manufacture of biopharmaceuticals. Guidance from the EMEA and FDA for the manufacture of biopharmaceuticals and medical devices encourages the use of “animal free” components to lessen concerns over contamination from adventitious agents such as prions, a cause of spongiform encephalopathy…
Humans have enjoyed large-scale protection against many infectious and contagious diseases since 1796, when Edward Jenner first introduced a vaccination against smallpox by an active immunization technique. Vaccination has proved itself to be the most successful solution for preventing the occurrence of many infectious diseases that previously caused serious illnesses, post-recovery ailments, and even death (e.g., smallpox, diphtheria)…
Despite the existence of effective vaccines against Hepatitis B virus, the infection with it remains an important problem worldwide due to its association with hepatocellular carcinoma. Several procedures have been used to purify the Hepatitis B surface antigen (HBsAg) for immunization purposes. Immuno-purification using HBsAg-specific murine monoclonal antibodies (MAbs) has been one of the most successful strategies for such a purpose due to the high antigen selectivity (high affinity) of MAbs…