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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..........

"Validation" or "Qualification" – What’s the difference?

I face this question on a regular basis from my clients, both internal and external. So what is the difference between qualification and validation?

Topic: Qualification / Validation, Topic: GMP Biol..........

Biospecimen-Based Research and the 21st Century Cures Act

“God Willing, This Bill Will Save Lives.” So said Vice President Joe Biden, in sharing his thoughts on the potential ramifications of the passing of the 21st Century Cures Act (H.R.6), made possible by the bipartisan leadership of Republicans and Democrats in the Senate and the House on December 13th 2016.

Topic: Cell Therapy Solutions, Topic: GMP Biologic..........

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

Chemical Storage in the Contract Environment

When we think of chemical storage we tend to think of large warehouses or factories designed to store chemicals in large quantities. However, the standards and regulatory requirements required of large chemical facilities still have to be met by smaller facilities. In smaller facilities and laboratories, chemical storage is often secondary to other tasks and functions. There are still a number of things you must do even if your primary business is not managing chemicals. In this blog, we’ll explore some of the necessary steps to properly manage chemicals as well as protect employee well-being. 

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

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..........

EU Commission Guidelines on Good Distribution Practice of IMP

Over the past few years there has been a notable increase in the number of temperature-controlled clinical supplies being transported all over the world. This increase can be attributed to the fact that a larger number of clinical trial drugs being tested today are of a biological nature. However, as discussed on the Fisher Clinical Services INSIGHTS blog, until recently little thought was given to ambient drug (generally set to be stored within 15°C – 25°C) being transported through a temperature controlled method as well.

Topic: Cold-Chain Logistics, Topic: GMP Biologics ..........

The Four Stages of Equipment Qualification

As discussed in my previous blog, qualification is the process of establishing documented evidence that a specific equipment, facility or system are fit and ready for their intended use. It establishes confidence that the equipment in a biorepository is capable of consistently operating within set limits and tolerances, and allows for conduction of tests to be performed on one element or component of the process to be validated against a specified outcome.

Now that we have a better understanding of the difference between Qualification and Validation, let’s expand our knowledge of the four equipment qualification stages.

Topic: Qualification / Validation, Topic: GMP Biol..........

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..........