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..........
[Video] Understanding Risk: How to Manage High Value Biologics Part 2
In part one of this video series, I discussed the importance of risk management and some things to consider when entrusting external parties with your valued samples. For part two, let's explore some additional factors to include in your risk threat assessment and ways to not only protect your samples, but also protect your data!
Content: Video, Topic: Biobanking and Biorepositor..........
[Video] Understanding Risk: How to Manage High Value Biologics Part 1
One of the things that I've learned that is very important to our clients and to our own organization is risk management. The management of risk is part of all business operations; however to those in the biotech industry that are manufacturing cell based therapies, risk mitigation is of utmost importance. The costly nature of your irreplaceable samples, valuable cell lines, and other high value product such as cell-based drugs, biologic active pharmaceutical ingredient (bio-API), dictates you and I to plan for the full continuum of risk. In this two-part video series, I'd like to share with you some of the questions you may ask yourself, or those you consider entrusting with your valued samples.
Content: Video, Topic: Biobanking and Biorepositor..........
Amazing Samples: Fungus - More Than Mushrooms
For thousands of years, humanity has had a… complicated relationship with fungus, though at points half-oblivious. On one hand, many cuisines across the world have made use of edible fungi or fermented food and drink for longer than you might expect – the ancient Sumerians liked beer so much, they honored the miracle of fermentation with the patron goddess Ninkasi almost four thousand years ago. On the other hand, fungi have been known culprits in food spoilage across the ages, and even if germ theory didn’t gain traction until the 19th century, that doesn’t change the fact that we have suffered various types of fungal infections since well before that.
This ambivalence still exists in modern time, but the balance is changing as handling processes have been improved and refined. Even if most fungal samples are still infectious, proper handling can prevent contamination, allowing those fungi to be used in a number of ways, from producing antibiotics to many of the cutting-edge biotechnologies being developed today. Last time in our Amazing Samples blog series, we discussed the value in stool. Today, let’s mull over what fungus provides to modern science.
Topic: Biobanking and Biorepository, Topic: GMP Bi..........
How Protein Folding Game is Impacting Biotherapeutic Discovery
Computers are an essential part of our daily lives. Yet, it appears that humans, particularly human gamers, have the edge over machines when it comes to solving complicated problems that require intuition and vision. The computer is confined to orderly practices and lacks the ability to have an “aha” moment. Contrarily, boundaries surrounding human research and discovery don’t exist, and human researchers use their perception to leap beyond what is “next” for the computer.
Topic: GMP Biologics Management, Content: Blog
Developing Ebola Vaccine and Securing Your Cold Chain Logistics Plan
Recent reports issued by the Centers for Disease Control and Prevention (CDC) show that efforts to contain the Ebola outbreak are yielding results. And even as we applaud the news, and also understand the need to continue the current efforts at an intense level, our collective attention is turning to the next step: developing a vaccine to prevent another outbreak.
Topic: Cold-Chain Logistics, Topic: GMP Biologics ..........
Amazing Samples: Antibodies
Antibodies are one of the most basic yet precise elements of the immune system: each antibody is associated with a specific antigen that fits to it like a key to a lock, and by binding to the antigen it serves to paint a target on the associated cell for other, more aggressive elements of the immune system to attack. Although antibodies were discovered more than a century ago – German immunologist Paul Ehrlich first coined the term Antikörper in an article he published in 1891—their use as therapeutic agents was limited by our lack of immunological methods.
Enter hybridoma technology. By fusing B-cells that produce the desired antibody with myeloma cells, it became possible to create a colony of hybridomas, all producing antibodies with identical antigen-specificity. Since the technology to humanize these monoclonal antibodies (mAbs) was developed in the late 1980’s, followed by chimeric and ‘fully’ human mAbs, many mAb-based therapies have been developed for a broad range of conditions, from viral to cancerous to inflammatory. However, these antibodies are very fragile and sensitive to temperature, and have to be stored and transported in ultra-low temperatures and sometimes down to liquid nitrogen, so we at Fisher BioServices have proudly had many opportunities to assist in the development and distribution of these biologics-based therapies. Last time, we discussed how cancer cells can be turned against themselves – this time, let’s showcase some of the different ways that monoclonal antibodies are truly Amazing Samples.
Topic: GMP Biologics Management, Topic: Amazing Sa..........
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