bg-img9.jpg
8.jpg
The Importance of Inventory Management: Do You Know Where Your Samples Are?

With the exciting advances in research and drug development, the importance of sample management has never been higher. If you have ever experienced sample management mishaps, we ask: Do you know where your samples are?

Topic: Biobanking and Biorepository, Topic: Public..........

Managing Refrigerated vs. Frozen Drug Product: What’s the Big Deal?

Here are two questions that illustrate our changing times in the pharmaceutical industry.

Topic: Biobanking and Biorepository, Topic: Cell T..........

Storing Biologics at Non-Traditional Temperatures

Maintaining the appropriate storage temperature of biological material is critical for downstream use. However, due to the complexity of this material and its sensitivity to temperature we are seeing an increase in non-traditional storage temperature requests. In this blog we’ll explore some of the reasons why this is occurring and the associated challenges.

Topic: Biobanking and Biorepository, Topic: GMP Bi..........

Entrusting Your Biologics with a Service Provider? Important Factors to Consider

Over the past decade, a wave of scientific advances and new technologies have made significant impacts on how medicines are discovered. The drive towards personalized medicine has led to an increased understanding of the molecular and genetic bases of disease. As a result of this increased knowledge, the life sciences industry is shifting its focus from small molecule medicine to biologic medicine, resulting in increased use of biologics in clinical trials and R&D efforts.

Topic: GMP Biologics Management, Content: Blog

Large-Scale Freezing of Biologics: Advantages and Challenges

Biopharmaceutical companies often produce millions of units of bulk biological materials that are then distributed for clinical use. This represents a significant supply chain challenge, as these materials need to be maintained within very specific environmental parameters. Temperature, humidity, and stress during material handling must be tightly controlled to prevent degradation of quality. Large-scale freezing of biologics provides a safe and effective method of storing biological materials, but this approach comes with unique challenges.

Topic: Biobanking and Biorepository, Topic: Cold-C..........

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..........

[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..........

Transporting Critical Bio-Material: How do you safely move an irreplaceable biospecimen collection?

Are you faced with the task of relocating a biospecimen collection? Moving a substantial inventory of samples is a logistical challenge, and requires managing temperature, equipment, regulatory, and personnel safety issues. The choice of vehicle used for transport may be low on the list, but the right truck can be critical to success.

Topic: Cold-Chain Logistics, Content: Poster, Topi..........

The Critical Importance of Inventory Management: Do You Know Where Your Samples Are?

With the exciting advances in research and drug development, the importance of sample management has never been higher. After recent examples of near misses and sample management mishaps, we ask: Do you know where your samples are?

In this blog, let’s explore some of the common causes of inventory mis-management and best practices to guard against sample loss and near misses.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Top 10 Concerns and Considerations in Cold Chain Logistics

There are many things to consider when shipping your high-value, temperature sensitive products using a cold chain logistics process.  These range from complying with regulatory standards set by the International Air Transport Association (IATA), Department of Transportation (DOT), Transportation Security Administration (TSA), and U.S. Customs and Border Protection (CBP), to including the correct domestic or international documentation to accompany your shipment on its journey.  Our list of top 10 concerns and considerations in cold chain logistics will help increase your knowledge of the process, understand how to avoid the common pitfalls often made, and implement the necessary parameters to ensure your product arrives safely and intact to its final destination.

Topic: Cold-Chain Logistics, Content: Blog

Biobank Relocation: Should the Freezer Units be ON or OFF?

Are you relocating an entire freezer full of research specimens? The ideal scenario is to leave the specimens in the cold storage unit and to transport the entire unit—which means keeping it in operation while it is in transit. However, refrigerators and freezers were never designed to operate while in motion, and keeping them running while bumping along a highway can damage the compressors, void the warranty, cause unit failure, and—why risk it?—allow your samples to thaw.

However, there is a way to transport freezers with the specimens inside, maintain correct temperature, and still protect the compressors: turn the units off and use controlled injection of liquid nitrogen (LN2) to maintain correct temperature.

Topic: Cold-Chain Logistics, Content: Blog