Solved With Heart & Science
Articles by technical and scientific subject matter experts
최신 과학 혁신, 약물 개발 혁신, 업계 인사이트 등을 확인하실 수 있습니다. 카테고리 별로 블로그를 검색하고 관련 포스트를 확인하세요.
관심 분야를 선택해 주세요.
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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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생체시료 저장소 구축의 장단점 비교
생체시료 저장소는 생물학적 물질을 수집, 보존, 활용하는 데 중요한 역할을 합니다. 이를 사내에 구축하는 것과 구입하는 것 중 어떤 것이 합리적일까요?
8 minute read
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바이러스 벡터 상용화 – Part 2: 프로세스 밸리데이션 주기 모범 사례
바이러스 벡터의 안전성, 유효성 및 품질을 보장하기 위한 다양한 평가 및 시험을 포함하는 바이러스 벡터 공정 밸리데이션 주기에 대해 자세히 알아보세요.
11 minute read
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CDMO 파트너를 선택할 시 고려해야 할 7가지
CDMO가 제약사와 협력하는 방법에 대해 알아보고 기업이 CDMO 파트너를 선정할 때 고려해야 할 주요 고려사항에 대해 확인하세요.
9 minute read
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CRDMO - CRO/CDMO 통합을 통한 의약품 개발의 재구성
의약품 개발사는 통합 CRO/CDMO와 협력함으로써 여러 아웃소싱 파트너와 협력해야 하는 복잡함 없이 새로운 치료법을 시장에 출시하는 과정을 보다 효율적으로 탐색할 수 있습니다. 통합 CRO/CDMO와 협력할 때 얻을 수 있는 이점에 대해 알아보세요.
9 minute read
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순응도 및 정확성: 스마트 패키징으로 임상시험에서 품질 필수 요건 개선하기
Thermo Fisher Scientific의 약물 순응도 및 바이오마커 책임자로부터 스마트 패키징의 데이터 품질 영향과 이를 임상시험에 통합하는 방법에 대해 확인하세요.
15 minute read
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약물 개발의 5단계
성공적인 상업화를 위해서, 모든 약물은 1) 약물 발견 및 개발 2) 전임상 연구 3) 임상 연구 4) FDA 검토 5) 안전성 모니터링의 5가지 특정 단계를 통과해야 합니다.
9 minute read
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CRO / CMO / CDMO 차이점
CRO, CMO, CDMO는 모두 약물 개발 및 제조와 관련된 서비스를 제공합니다. 자료에서는 이 세 조직과 서비스의 차이점을 설명합니다.
9 minute read
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세포 및 유전자 치료제 개발 - 환자 중심의 접근 방식
블로그 포스트를 통해 세포 유전자 치료제 개발의 환자 중심적 접근 방식에 대해 알아보세요.
8 minute read
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통합된 업무 프로세스를 통한 디지털 업무 환경 조성
안정성과 경험이 중요한 물리적 업무 환경과는 대조적으로, 디지털 업무 환경은 혁신과 연결성에 초점을 맞춥니다. 자료를 통해 디지털 업무 환경 조성에 대한 자세한 내용을 확인하세요.
4 minute read
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바이러스 벡터 상용화 – Part 1: 기술 이전 프로세스
기술 이전으로 바이러스 벡터 개발과 생산 규모를 확장하고, 백신 및 유전자 치료제 상용화 속도를 높이는 방법을 확인하세요.
9 minute read
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Keeping your information safe: IP and data protections in China and across the globe
Experts at Thermo Fisher discuss rigorous contractual, project team, and data protections that are in place to keep customers’ intellectual property and confidential information secure.
12 minute read
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Manufacturing in China for China: Navigating the regulatory landscape
Experts at Thermo Fisher provide insight into the registration and approval pathway for developing and marketing biologic therapies in China for the domestic market.
12 minute read
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Viral vector commercialization – Part 3: Specialized regulatory support
Find detailed regulatory considerations when preparing viral vectors for commercialization and best practices to address them.
7 minute read
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Ensuring Quality Consistency at Hangzhou Site
Find Q&A insights from experts at Thermo Fisher on the quality systems framework that guides quality implementation at our new Hangzhou site.
12 minute read
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Patheon Translational Services Advance Cell and Gene Therapies from Research to Clinical Trials
Learn how our translational research services, housed in our San Diego facility, can take cell and gene therapies from preclinical to clinical.
6 minute read
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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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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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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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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
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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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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
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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
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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
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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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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