Characterization of biopharmaceutical stability with Differential Scanning Calorimetry

| May 22, 2017

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Protein stability is critical to the success or failure of the development of a biopharmaceutical. Protein stability is an important parameter during production, manufacturing, formulation, long term storage, delivery to patient, and efficacy. Highly stable proteins will likely have fewer issues during the manufacturing process, are more cost-effective to produce, and will have a better chance of remaining functional during formulation and storage without chemical alteration or aggregation.

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Clinimetrics

As a niche Contract Research Organization (CRO), Clinimetrics focuses on the needs of biotechnology and early stage pharmaceutical and medical device companies.

OTHER ARTICLES

Top Pharmaceutical Firms Urge FDA to Adopt Blockchain for Drug Tracking

Article | February 25, 2020

Leading market participants in the United States pharmaceutical industry, logistics firms, distributors and other stakeholders in the pharma supply chain have come together to publish a report buttressing the need for industry players to adopt blockchain for tracking prescription drugs, following the successful completion of a DLT pilot project with the Food and Drug Administration (FDA), according to reports on February 24, 2020. Though nascent, blockchain technology, the building blocks of Bitcoin (BTC) and other cryptocurrencies are fast gaining ground across various ecosystems, due to its immutability, security, privacy, and other intricate properties. In the latest development, 25 leading manufacturers of pharmaceutical products, logistics partners and other market participants in the pharma supply chain, have published a report that highlights the importance of blockchain technology in drug traceability.

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Global Antiviral Drugs Market Growth: Is Antiviral Drug the Best Coronavirus Treatment?

Article | April 9, 2020

The global antiviral drugs market has witnessed a rapid surge in demand due to the ongoing Covid-19 pandemic worldwide. So is antiviral drug the best coronavirus treatment? It is still too early to have that conclusion as many medical research and clinical trials are still trying to find the effectiveness and potential side effects of using antiviral drugs to treat coronavirus. But experts believe that antiviral drug might be the best hope for reduce the coronavirus transmission around the world at this stage. However, due to the current difficult situation of the supply chain in many lockdown countries and regions, there is a global shortage on the antiviral drugs supply. With researchers and manufacturers working hard to find and provide effective coronavirus treatment, it is expected that the global antiviral drugs market will have a significant growth over the near future. Antiviral drugs are a type of medication used specifically for treating viral infections, such as human immunodeficiency virus (HIV), hepatitis, and influenza.

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New Dimensions of Clinical Trial Optimization

Article | April 20, 2021

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization. The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options? For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design. Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices. Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them. Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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Comparing HydroxyChloroquine Trials

Article | April 1, 2020

One minor side effect of the pandemic is that perhaps more people will learn about what drug research and clinical trials can really be like. Today’s example: we have a clinical trial of hydroxychloroquine from Wuhan that has just published on a preprint server. What’s good is that this one is blinded, randomized, and controlled (like the earlier hydroxychloroquine which one I blogged about here from Zhejiang University, so we can actually talk about it rather than just spend all our time wondering what the heck is going on.

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Spotlight

Clinimetrics

As a niche Contract Research Organization (CRO), Clinimetrics focuses on the needs of biotechnology and early stage pharmaceutical and medical device companies.

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