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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

Minimizing Waste through Practical Process Improvement

Personal Protective Equipment (PPE) is necessary to ensure the safety of personnel in a biopharma environment.  However, have you ever considered the amount of waste that accumulates from the use of laboratory nitrile gloves and other single use apparel?

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

Keeping It Cool: Protecting Cryopreserved Biological Samples from Degradation

As discussed on the Inside Biobanking blog, cryopreservation requires a slow cooling process to reach temperatures at or near the temperature of liquid nitrogen (−196°C). This method is standard practice in preserving biological samples. In their recent review, Woods et al. (2016) examined cryobiology applications in cryopreservation to identify new solutions to integrate into mainstream cell therapy.1

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

Trade Compliance: The Increasing Challenge of Transporting Material In and Outside of the US

Have you noticed that it has become increasingly difficult to transport your material into and out of the United States? That’s because it has!

Topic: Cold-Chain Logistics, Content: Blog

Advanced Therapies: Reimbursement and the Impact of Hidden Supply Chain Costs

While the potential for advanced therapies to provide curative treatments to patients around the world is very exciting, the pricing strategies and reimbursement models to support this innovation are quite complicated.  In this blog, I’ll explore the cost vs. price paradigm, through a supply chain lens, highlighting hidden costs and their impact on reimbursement potential.

Topic: Cell Therapy Solutions, Content: Blog

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..........