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Determining Optimum Maintenance Temperature for Advanced Therapies, Part 2

As discussed in my previous blog, there are many factors that need to be considered when selecting an effective maintenance temperature. Those factors include volume, handling processes, storage, and equipment. In part two of this blog series, I will focus on the impact that some of these variables can have on determining an optimum maintenance temperature for advanced therapies.

Topic: Cell Therapy Solutions, Topic: Biobanking a..........

Case Studies in Supply Chain Management: Getting it Right From the Start Part 2, Planning for Allogeneic Therapies

As discussed in my previous blog post, consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial.  It is important to remember that each part of the supply chain is equally critical and requires careful management and strategic planning.

Topic: Qualification / Validation, Topic: Cell The..........

Fisher BioServices Top Five Most Popular Blogs of 2017

2017 has been a year filled with new discoveries in the health and medical R&D space. Through our blog, we have shared great stories of our customers' work and discussed a wide-breadth of topics, focusing on advanced therapies, biological material, and public health research.

Content: Blog, Topic: Biobanking and Biorepository..........

Case Studies in Supply Chain Management: Getting it Right From the Start Part 1, Planning for Autologous Therapies

Consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial. In this two part blog series I’ll review two case studies that demonstrate the importance of supply chain management by focusing on scaling up for commercial distribution and on packaging challenges within a cryogenic environment.

Topic: Cell Therapy Solutions, Content: Blog, Topi..........

Determining Optimum Maintenance Temperature for Advanced Therapies, Part 1

As referenced in a previous blog post, understanding the proper method of safely cryopreserving your material is essential, but of equal importance is determining the optimum maintenance temperature. There are many factors that need to be considered when selecting an effective maintenance temperature. Those factors include volume, handling processes, storage and handling equipment and the impact of multiple short duration exposures. In this two part blog series, we’ll discuss four areas that need to be understood to determine the optimum maintenance temperature for advanced therapy material.

Topic: Cell Therapy Solutions, Content: Blog, Topi..........

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

What is the difference between qualification and validation? This question comes up frequently with both internal and external clients. 

Topic: Qualification / Validation, 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..........

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 ..........

Why GMP? An explanation of Good Manufacturing Practice

GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments. These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined under FDA 21 CFR Part 210-211.

The first set of Good Manufacturing Practices (GMP) regulations were published in 1963. These regulations are meant to guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products.

In this blog we'll discuss the definition of GMP, various regulatory components, and why it's important for companies in the life sciences space.

Topic: Biobanking and Biorepository, Topic: Qualif..........

First Pass Yield or Quality Yield, Wait… What’s the Difference?

Manufacturing-related quality statistics aren’t normally associated with biorepositories, but the world of statistical process improvement tools can be very useful for biobanking. One such case is the difference between two basic statistical metrics — Quality Yield and First Pass Yield.  I'd like to shed some light on both metrics starting with their definition, then propose a recommendation of which to use in a biorepository setting, and conclude with a proposed performance target level.

First Pass Yield vs. Quality Yield

Quality Yield (QY), also known as Final Yield (FY)1 represents the acceptable pieces at the very end of a process divided by the original number of pieces fed into the process. In a manufacturing setting, this tells you the overall proportion of acceptable results; if the number of units of acceptable quality at the end of the process is the same as what can be expected given what is fed into the process, then you have achieved a 100% Quality Yield.1

Topic: Biobanking and Biorepository, Topic: Qualif..........