The Importance of Freezer Qualification for Biologics
For those studying, manufacturing, or experimenting with delicate pharmaceuticals and biological samples, the importance of storage and accurate temperature monitoring is well known. From a qualification and validation perspective, the equipment and processes used for shipping, storing, and other services must comply with the products’ requirements throughout the chain of custody.
In this two part blog series I will convey the importance of qualifying the equipment and validating the processes through which your valuable biological material is managed.
Topic: Qualification / Validation, Topic: GMP Biol..........
Accidental Freezing of Vaccines
When discussing the impact of temperature on vaccines, heat is the better-known hazard. However, while the vaccine cold chain is a way to protect vaccines from inactivation associated with high temperatures, exposure to low temperatures can also result in potency losses. In a 2007 study, researchers found that vaccines were exposed to freezing temperatures in 14 to 35 percent of refrigerators or transport shipments. Thus, accidental freezing of vaccines poses a significant and growing threat to national immunization programs. And in locations where the equipment is not qualified or the process is not validated, the impact of environmental temperatures on the vaccines could be significant.
Topic: Cold-Chain Logistics, Topic: Qualification ..........
Biobanking for Biologics and Cell Therapies: All Biobanks Are Not the Same
Until recently, most biorepositories were primarily used for archival sample storage. Researchers would generate large sample collections for research with a broad idea of how they would or could be used. Although this required expert temperature monitoring while in storage at biorepositories, it did not demand a lot of transactional activity, debits and credits from the inventory, as there was no defined use for the sample.
However, in the last ten years the industry landscape has evolved. With the introduction of advanced biotherapeutics and personalized medicine, biorepositories have transformed from archival storage facilities into true biobanks where the overall workflow now includes numerous complex transactions. Many of these transactions are associated with adding value through an integrated workflow that seamlessly connects the sponsor, bio-manufacturer, clinical center, and patient into a tandem, well-coordinated process chain. Additionally, in some instances sample collections are developed with a more targeted end-use in mind, resulting in smaller inventories.
Let’s explore the expanded focus across our industry from biorepositories for traditional research (biospecimens) to biobanking for therapeutic components (biologics and cell therapies).
Topic: Biobanking and Biorepository, Topic: Cell T..........
Personnel Safety When Cryopreserving Biological Material
To maintain biological integrity and prevent sample degradation, biosamples can be cryopreserved. Since this requires very low temperatures, the correct preparation of these biospecimens for cryopreservation is critical; particularly when the samples are intended for use in downstream analysis such as immunological assays for detecting cell surface markers.
In our previous blog, 5 Factors to Consider When Storing Samples at Low Temperatures, we identified various procedures including proper handling, preparation, freezing, retrieval, and thawing measures that must be followed when cryopreserving samples to maintain cell viability. However, while following process to maintain sample integrity is an integral part of cryopreservation, there are also specific safety requirements that must be followed.
A recent blog by Inside Biobanking, addressed some of the hazards associated with biological material management at cryogenic temperatures. In this blog, let's explore how staff and biobank managers can ensure personnel safety by following these safety guidelines.
Topic: Biobanking and Biorepository, Topic: Cold-C..........
QP Essentials : Your EU Gateway to Clinical and Commercial Distribution of Cell Therapeutics
QPs—Qualified Persons–serve as the eyes and ears of the UK Medicines and Healthcare product Regulatory Agency (MHRA). Their primary focus is to protect patients by ensuring that medicinal products have been manufactured and handled according to GMP and European Union regulations. By protecting the patient, QPs also serve to help and protect the manufacturer.
Content: eBook, Topic: GMP Biologics Management