Solved With Heart & Science
Articles by technical and scientific subject matter experts
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Blog post
Top tips for providing the right amount of detail in first-in-human common technical documents
In the early-development stage, little may be known about a drug’s characteristics. What’s more, drug processes and formulations frequently evolve as more information emerges following testing and trials. Learn more.
5 minute read
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Enabling a digital culture through integrated business processes
In contrast to a physical work environment, where stability and experience are key, a digital business environment focuses on innovation and connectivity. Learn more.
4 minute read
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Delivering on the promise of cell and gene therapies: A patient-centric approach
8 minute read
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Gaining a deeper understanding of your API
As active pharmaceutical ingredients (APIs) become increasingly complex, they pose potential formulation problems that can extend timelines and explode budgets. Read this blog to learn more.
5 minute read
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EU and US regulations: What’s coming for cell and gene therapies?
Cell and gene therapy (CGT) developers today face an added challenge in their quest to bring a product through clinical trials and to the market. Read this blog to learn more.
7 minute read
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Choosing a CDMO for mRNA success: Five CDMO characteristics needed
The promise of mRNA technologies has been clearly demonstrated during the COVID-19 pandemic, with vaccines reaching the market in record time. The vital role...
7 minute read
Blog post
Trends in mRNA therapeutics: Pandemic learnings for a pathway to success
The rapid advancement of the Pfizer-BioNTech and Moderna messenger RNA–based COVID-19 vaccines from lab to clinic—with development taking less than one year—has validated the...
5 minute read
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Moving from vials to prefilled syringes for vaccines: Three key success factors
As pharmaceutical companies become more patient-centric and self-administration of injectable drugs continues to increase, the market for drug products in prefilled syringes is forecast to grow, reaching $9.53 billion by 2026.
4 minute read
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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.
3 minute read
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Myths & Facts about Ancillaries
It’s a fact that ancillary supplies are frequently perceived as less important than study drug.
2 minute read
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Is Your Supply Chain Bulletproof?
Before you respond, think hurricanes, Nor’easters and tsunamis. Earthquakes, typhoons and volcanic eruptions. Civil unrest and war. Terrorism. A pandemic virus.
2 minute read
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Top Tips on How to Manage Clinical Label Translation and Regulatory Requirements
Wouldn’t it be nice to find a way to stay on top of label translation and regulatory requirements for every country included in your clinical trial?
2 minute read
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Introducing an Expanded Packaging Service for Specialty Products
Developing a specialty drug for a complex or rare disease is an achievement worthy of celebration.
2 minute read
Blog post
Is it Time to Start Thinking about Packaging?
If this headline caught your eye, it may be because you’ve received promising pre-clinical results (Congratulations!) and you’re starting to think about planning your next steps.
2 minute read
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Taking Your API to the Next Level: Three Steps to Consider Before Outsourcing
With outsourcing API development becoming more common, we see a rise of multiple competing Contract Development Manufacturing Organizations (CDMOs) as potential development partners.
10 minute read
Blog post
Break Through the OTC Noise
It’s no secret—consumers have a vast range of OTC options at their favorite in-store or online retailer. Everything from tablets and capsules, to syrups—consumers have more options than ever in the OTC jungle.
8 minute read
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Considerations and roadblocks that stifle orphan drug development
According to the US Food and Drug Administration (FDA), “2020 was a record-breaking year in terms of the number of orphan drug designation and rare pediatric disease designation requests submitted to the Office of Orphan Products Development.”
6 minute read
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Regulatory landscape in Europe: Key advice for meeting post-Brexit Qualified Person requirements
The United Kingdom’s (UK) departure from the European Union (EU) has added a layer of complexity to the clinical trial supply chain in Europe above and beyond COVID-related disruptions.
(4 minute read)
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Time to embrace electronic labels? Potential labeling solutions under the new EU Clinical Trial Regulation
The new EU Clinical Trial Regulation (CTR) is intended to simplify clinical trial administration and create a more welcoming climate for pharmaceutical companies that operate in Europe.
5 minute read
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Navigating the Complexities of Process Performance Qualification
Method qualification is monumentally important before process performance qualification (PPQ). This early assessment of your method’s performance characteristics is critical as it pertains to method validation and its parameters such as precision, accuracy, and linearity.
5 minute read
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Continuous Manufacturing: An Efficient Way to Produce OSD Drugs
When Henry Ford revolutionized manufacturing practices back in 1913 in Highland Park, MI, his main goal was simple—to make the best possible product in the most efficient and cost-effective manner. Ford’s focus on bettering the “flow” of manufacturing to enable workers/technology to work smarter and reduce waste of raw materials, changed manufacturing principles forever.
6 minute read
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Simplifying Your API's Development Journey
The primary way new drugs are developed is changing. Historically, pharma companies—particularly large pharma companies—have developed APIs in-house.
7 minute read
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COVID-19’s Silver Lining: Accelerated Vaccine Development
Vaccine development is a lengthy process—it is expensive, attrition is high, and to get a licensed vaccine to everyone, it takes multiple candidate iterations. Vaccine development for pandemics and epidemics is risky, and due to the novel nature of viruses, certain unknown factors can derail a vaccine program.
6 minute read
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A Day in the Life of a Viral Vector Partner
When it comes to a viral vector Contract and Development Manufacturing Organization (CDMO), what sort of qualities should they possess?
9 minute read
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How Decentralized Clinical Trials Enhance Patient-Centricity in the Age of COVID-19
As COVID-19 continues to change how we do business in the biopharmaceutical industry, it’s important to not lose sight of why we do what we do: improving and saving patient lives.
5 minute read
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Work Smarter, Not Harder: Accelerating Your Biologics Development and Commercialization
Over the past decade, the biologics industry has seen double digit growth and an overall increase of market share.
5 minute read
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Prefilled Syringes: Three Pain Points You May Not Have Considered
As pharmaceutical companies look to become more patient-centric, certain drug products come to the forefront to support that effort.
5 minute read
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Navigating Cell & Gene Therapy Regulations: How Does Your CDMO Match Up?
Whether you are a large or new and emerging biotech company, many companies find themselves lacking the internal resources and/or expertise to properly support regulatory submissions.
7 minute read
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Choosing a CDMO Who is a True Bioproduction Expert
With the number of CDMO’s rising in the biologics manufacturing industry, it can be challenging for new and emerging biopharmaceutical companies to determine which CDMO is right for them.
8 minute read