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Optimizing Advanced Therapy Supply Chain Design to Ensure Commercial Success

The advanced therapy supply chain is complex and made up of multiple moving parts. With milestone achievements such as the recent FDA approval of Novartis' CAR-T cell therapy Kymriah™ it's essential that we address the challenges of delivering these ground breaking therapies to patients on a global scale.

Topic: Cold-Chain Logistics, Content: Webinar, Top..........

Halting the Next Ebola Epidemic

Prior to 2014 Ebola was mostly seen as a deadly disease, but contained in remote areas of the world with a low likelihood of spreading. However, this false impression was dispelled when the disease hit heavily populated urban areas. Suddenly the world realized the Ebola outbreaks could reach epidemic proportions, and with an average fatality rate of approximately 50%, the potential impact could be catastrophic. In response, the scientific community rushed to develop a vaccine.

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

Global Biobank Week: Towards Harmony in Biobanking

Hospitals, biopharmaceutical companies and academic researchers rely on biobanks and biorepositories for the most critical piece of the puzzle – biological samples and their associated data. Biobanks play an important role in enabling researchers to develop therapies for chronic diseases. They are key components in the research of new treatments and the identification of disease biomarkers from the large cohorts of patients through the collection, storage, inventory, characterization and distribution of valuable samples.

Thus, we are pleased to announce our participation at the upcoming Global Biobank Week (GBW) 2017 in Stockholm, Sweden.  GBW provides a global platform for comprehensive discussion and collaboration on activities important for biobanking and biopreservation of samples and data to improve healthcare and decrease the burden of disease worldwide.

Whether you’re managing the inventory of a freezer or an entire biorepository, we have a solution for all of your biobanking needs.  For decades, customers have relied on our biobanking solutions and services to preserve sample quality and improve efficiency at every stage of the workflow.  From sample collection and preparation, to sample analysis and sequencing, to cold storage and automation, we have the equipment, consumables, software systems, and full services needed to ensure reliable, efficient sample management and monitoring.

 

Come visit us at booth #26 for a chance to win a portable power bank and to check out our interactive virtual biobankWe look forward to sharing our solutions with you and discussing the latest breakthroughs in biobanking.  In the meantime, check out our eBook Biobank: Should you build or outsource?. It presents 10 questions to consider before you decide to build or outsource a biobank project, important components and costs for building and managing a biobanking, and some additional resources.

Download eBook

Topic: Biobanking and Biorepository, Content: Blog

Use of Mobile Technology to Enhance Biospecimen Quality and Biobank Efficiency

Population-based biobanking is an essential aspect of biomedical research. When biobank samples are collected outside of clinical or research facilities, chances for variation in sample collection, handling, and shipping increase. Any lack of standardization before, during, or after collections can generate unwanted pre-analytical variability that hurts future use of biospecimens.

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

Controlling Complexity [Not Cost] of Advanced Therapy Supply Chain

Due to the short shelf life and clinical criticality of advanced therapies, their supply chains are often highly complex.  Once efficacy and safety is demonstrated, the focus of advanced therapy developers moves to controlling cost.  However, the biggest cost within the supply chain is caused by its complexity.  In this blog we will share why the advanced therapy supply chain is so complex and how this complexity correlates to cost.

Topic: Cell Therapy Solutions, Content: Blog

Importance of Early Planning for Cell Therapy Clinical Trials

As discussed in previous blog articles, early planning is critical, both for cell therapy clinical trials and commercial-scale operations. By addressing how activities will be managed early on, it can minimize risk and cost, and optimize downstream processes. However, oftentimes clients are unsure of which components are critical to address early on.

Topic: Cell Therapy Solutions, Content: Blog

Next-Gen Bioinformatics: The Expanding Role of Deep-Learning Algorithms

Deep-learning algorithms have shown significant promise as applications in natural language understanding, decision making, and speech and image recognition. These algorithms are now being applied in bioinformatics applications within the biopharma industry to manage the increasing amounts of data from high-throughput techniques. As a bioinformaticist, I am particularly fascinated with recent applications of these algorithms to predict a variety of biological processes and interactions, particularly with respect to proteins. 

Topic: Biobanking and Biorepository, Topic: Labora..........

CRISPR-Cas9 Off-Target Effects

In our previous blogs on cell therapy solutions, we summarized the CRISPR-Cas (Clustered, Regularly Interspersed, Short Palindromic Repeats) system as a remarkable tool for greatly simplifying gene manipulation (insertions, deletions, development of knock-in and knock-out animal models).  Also described were ways to study epigenetic processes by ‘borrowing’ the Cas9 nuclease from the CRISPR system to pair with histone acetylation domains for induction of acetylation at specific sites.  For instance, one application of this capability could be applied in gene therapy, whereby incorporation of epigenetic changes could achieve gene silencing of abnormally activated genes, or by controlling stem cell differentiation.

Topic: Cell Therapy Solutions, Content: Blog

Reducing Cost within Advanced Therapy Clinical Trials

The challenge for advanced therapy companies is that they need to develop a supply chain that delivers their therapy, at scale, without adding significantly to the cost of goods sold (COGS). In this case study we’ll demonstrate how a company saw 55% cost savings across its distribution system, and increased visibility of its supply chain through meaningful data. By trusting our team of experts to deliver a robust global storage and logistics strategy, the clinical trial ran more efficiently and provided the Sponsor company with the confidence to focus on other high value activities.

Topic: Cold-Chain Logistics, Topic: Cell Therapy S..........

The RMAT Designation: What it means to the advanced therapy supply chain

The ever-increasing demand for healthcare advances has prompted legislators to consider means of facilitating the development of potentially life-saving new therapies. In this guest blog, Alison Wilson will review the definition of a regenerative medicine advanced therapy (RMAT) and how this designation can facilitate speed to market for these innovative therapies.  Alison is an independent regulatory affairs consultant specializing in human cell and tissue-based advanced therapies.

Topic: Cell Therapy Solutions, Content: Blog

Importance of Chain of Custody Documentation for Biologics

Preventing patients from receiving “counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the US Food and Drug Administration (FDA). The protection of the pharmaceutical supply chain is one of the FDA’s highest priorities, and chain of custody is one of the FDA’s primary tools in this mission. Chain of custody, when correctly executed, allows determination of “who, what, and when” with a high level of confidence. For advanced therapies—those derived or generated through biotechnology—chain of custody not only includes verification of “who, what, and when,” but also “at what temperature.”

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

Conducting the Advanced Therapy Supply Chain Orchestra

A coordinated supply chain management plan is crucial when developing advanced therapies.

Topic: Cell Therapy Solutions, Content: Blog