Visit booth #80-81 at AusBiotech 2024 to learn how our end-to-end CDMO and CRO services and solutions can support your unique drug development and manufacturing journey.
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.
Visit Thermo Fisher Scientific’s booth at GCSG 2024 from October 15-17, 2024, in Malta to discover our CDMO and CRO services and solutions designed to accelerate your clinical trials.
12th Annual Outsourcing in Clinical Trials Nordics 2024
Meet with Thermo Fisher Scientific at the 12th Annual Outsourcing in Clinical Trials Nordics 2024 to discover our CDMO services and solutions, including comprehensive capabilities for clinical trials.
Visit booth #100 at BIO-Europe 2024 from November 4-6 in Stockholm, Sweden, to discover our CDMO and CRO services and solutions for large molecule drugs, including biologics.
Join Thermo Fisher Scientific at ISPE Singapore 2024 from August 29-30 to explore our CDMO services and solutions in APAC and beyond. Visit our team at booth #244 or schedule a private 1:1 meeting now.
Join us at DCAT Week in New York City where will be discussing the elements of a trusted partnership and what’s needed to ensure your project goes smoothly.
Indian Society for Clinical Research — 17th Annual Conference
Visit our booth at ISCR 2024 to learn how our comprehensive CDMO services and solutions can support your clinical trial management and supply chain logistics needs.
COVID-19 팬데믹 기간 동안 업계는 mRNA 기반 백신의 신속한 개발과 승인을 목격하며 종양학, HIV, 희귀 질환을 위한 치료제를 위한 mRNA 기술 적용에 높은 관심을 보이기 시작했습니다. mRNA의 생산 속도와 유연성은 매력적이지만, 완전한 잠재력을 실현하고 그 사용을 더욱 확장하기 위해서는 여전히 몇 가지 업계 과제를 해결해야 합니다.
Thermo Fisher Scientific은 바이러스 벡터 제품의 개발 및 생산에 있어 20년 이상의 경험을 자랑합니다. 선도적인 CDMO로서, 당사는 공정 및 분석 개발, 공정 밸리데이션, 임상 및 상업용 제조, 공정 중/출하 시험, fill-finish 서비스를 모두 포함하는 end-to-end 바이러스 벡터 서비스를 제공합니다.
독성연구는 IND 전 규제 요건을 뒷받침하고 약물의 위험성-유익성 비율을 평가하는 데 중요합니다. 당사의 바이러스벡터 direct-to-toxicology 프로그램은 아데노 연관 바이러스(AAV) 및 렌티바이러스(LV) 생산 공정을 통해 독성연구 물질로의 경로를 신속하게 처리하여, 이 과정을 최소 6개월 내에 완료합니다.
유전자 치료제를 위한 바이러스 벡터의 개발과 상업 생산 과정에서 여러 도전 과제를 알아보고 프로젝트를 비용 효율적으로 성공시킬 수 있는 방향을 제시합니다. 통합적인 개발/생산 접근 방식을 활용하면 의사 결정을 간소화하고 자원을 효율적으로 활용함으로써 맞춤형 솔루션 이상의 혜택을 얻을 수 있습니다.
Visit booth #24-25 at AusBiotech 2023 to learn how our end-to-end CDMO services and solutions can support your unique drug development and manufacturing journey.
Join us at the Cell & Gene Meeting on the Mesa, where our CDMO experts will be available to discuss how our expertise, capacity, and global network can address your project’s unique needs.
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.
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.
Crystallization process development, small molecules and biological macromolecules
Particle engineering
Downstream processes (solid-liquid separation and drying)
Solid state chemistry and solid state analysis
Focus Area
API (small molecule)
Credentials
Habilitation (higher doctorate) in chemical engineering from MartinLuther-University Halle-Wittenberg, Halle (Saale), Germany
Doctor of Philosophy from the University of London, University College, U.K.
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.
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.
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.
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...
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...
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.
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.
Before you respond, think hurricanes, Nor’easters and tsunamis. Earthquakes, typhoons and volcanic eruptions. Civil unrest and war. Terrorism. A pandemic virus.
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.
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.
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.
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.
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.
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.”
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.
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.
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.
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.
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.
In-House Versus Outsource: A Decision-Making Guide
바이오 의약품 시장은 블록버스터 의약품 생산에서 미충족 수요의 치료제를 연구하는 틈새시장으로 이동하고 있습니다. 이로 인해 경쟁이 심화되고 개발 일정이 촉박해지며 역량 부족의 문제가 대두되는 등 후보물질의 성공적인 개발을 방해하는 여러 위험 요소가 제기되고 있습니다...
Impact of a pandemic outbreak on vaccine development approach
백신을 개발 과정에는 많은 장애물이 존재합니다. 그러나 팬데믹 기간 동안의 백신 개발에 있어서는 기존의 제조 방식으로는 해결할 수 없는 고유의 복잡한 문제가 존재합니다. 지난 10년간 H1N1 인플루엔자, 사스-코로나바이러스(Sars-Cov), 에볼라, 메르스의 발생은...
세포 유전자 치료제(CGT)는 현재 세계에서 가장 빠르게 성장하는 치료 분야 중 하나입니다. 이러한 치료법은 환자를 평생 치료하는 아니라 완치를 목적으로 합니다. 절차를 간소화하려는 노력의 결과로 CGT 제품의 개발 일정은 기존 대비 단축되었으며, 이에 따라 제약사는 특수한 도전과 기회를 얻게 되었습니다. CGT 업계가 성숙함에 따라 지침과 규제 표준이 지속적으로 엄격해지고 진화하고 있으므로 기업은 의약품의 성공을 위해 규제 당국과 밀접하게 협력해야 합니다.
10 Reasons Formulation Complexity is on the Rise in Steriles
초기 개발 기간에는 제제의 복잡성 등 의약품 연구를 다음 단계로 진행하는 데 방해가 되는 다양한 도전과제가 존재합니다. 다양한 요인으로 인해 무균 주사제 개발의 복잡성은 점점 더 증가하고 있습니다. 특히 이는 업계 전체가 다음 이슈에 중점을 두고 발전하기 때문에 발생하는...
Manufacturing Innovation: The Case for Continuous Manufacturing
CDMO가 경구제의 연속 생산 공정을 제공함에 따라 이 제조 기술을 활용하고자 하는 기업은 과거와는 다른 비즈니스 케이스를 확보할 수 있게 되었습니다. 최근까지만 해도 기업이 상업 생산 공정에 연속 생산을 도입할 수 있는 유일한 방법은 초기에 상당한 자원을 투입하여 기술 역량을 개발하는 것이었습니다...
How Adaptable Manufacturing Models are Paving a Steady Path into an Unpredictable Future
In a short 20 minutes, you can learn about manufacturing trends, adaptable manufacturing models, and take a tour of Pacira’s condominium manufacturing facility at Patheon’s Swindon location.
Getting from R&D to IND – Pitfalls to avoid and how to succeed
IND까지의 개발 과정에는 언제나 어려움이 따릅니다. 개발 속도, 위험 완화, 미래의 가치 사이의 균형을 맞추는 것은 쉽지 않습니다. 향후 스케일업과 상용화를 위한 안정적인 기반을 확보하는 동시에 위험 완화와 일정 단축 사이의 균형을 찾아 후보물질에서 FiH 임상시험까지 진행...
Fixed dose combination drug development: Designing a lifecycle strategy with agility & speed
FDC와 약물 재창출은 의약품의 Lifecycle 관리 전략의 일환으로 일반적으로 채택되고 있습니다. 이러한 전략은 새로운 적응증에서의 부작용이나 임상 효능 평가를 줄일 수 있다는 장점이 있습니다. 다양한 이유로 심사가 보류된 의약품을 검증된 안전한 승인 의약품과 조합하면...
Cell and gene therapy manufacturing in a post-covid world
포스트 코로나 시대, 세포 유전자 치료제 제조 최적화 방법
팬데믹으로 인해 세포 유전자 치료제 제조사는 원료 물질 부족, 무리한 제조 역량 사용, 과중한 공급망 물류 부담, 연구 및 임상 개발의 중단과 관련된 문제에 직면했습니다. 이러한 상황에서, 세포 유전자 치료제 제조사들은 치료제의 임상 및 상업화 성공을 위해 공정을 최적화, 간소화해야 한다는 점을 깨닫게 되었습니다...
Find out how to avoid delays in translating and approving clinical labels that can prevent clinical trials from starting on time and threaten to derail development timelines.
Clinical Trial Packaging Solutions: Balancing Cost, Time and Quality
매년 10,000개 이상의 패키징 관련 일자리를 창출하는 4,500건 이상의 임상시험을 지원하다 보면 확실해지는 한 가지 사실이 있습니다. 그것은 바로 경험의 축적입니다. 이는 시간, 비용, 품질 사이에 최적의 균형을 맞추고자 노력하고 있는 임상 의뢰자들에게 소중한 통찰이...
Quick to Care™ drug development integrated management service for emerging pharmaceutical companies
Quick to Care는 모든 의약품 개발 단계를 포괄하는 end-to-end 통합 맞춤형 관리 솔루션으로 원료 의약품 및 완제 의약품 개발, 패키징, 라벨링, 보관 및 유통을 포함한 임상 시험 공급 솔루션, 인허가 서비스, 운송 관리, 상업 생산 및 패키징 등을 결합하여 모든 개발 단계의 의약품 개발을 가속화합니다.
Steriles drug development and manufacturing: Flexibility and optimization
지난 5년간 무균 주사제 분야가 10% 급성장함에 따라 개발 및 제조 측면에서의 생산성 확대와 혁신적인 솔루션에 대한 필요성이 대두되었습니다. 복잡한 규제 환경 대응, 분석, 공정 개발 및 최적화, 정시 생산은 모두 무균 주사제의 성공적인 생산에 필수적인 요소입니다...
Quick to Care™️ 프로그램은 의약품 개발, 임상 서비스의 통합적인 관리를 지원합니다. 원료 의약품 및 완제 의약품 개발, 패키징, 라벨링, 보관 및 유통을 포함한 임상 시험 공급 솔루션, 인허가 서비스, 운송 관리, 상업 생산 및 패키징 등을 결합하여 모든 개발 단계의 의약품 개발을 가속화...
What seemed impossible became achievable when Thermo Fisher Scientific manufactured and released a one-of-a-kind treatment in a record timeline of 30 days.
Michel Lagarde, Executive Vice President, Thermo Fisher Scientific, discusses why Pharma Services employees are so passionate about partnering with small and emerging biopharma clients.
Preparing cell and gene therapies for regulatory submission
When preparing to ramp up late stage manufacturing for commercialization, understanding key critical to quality parameters will help prepare your therapy for regulatory submission.
Thermo Fisher Scientific & CSL Enter Strategic Partnership to Provide Best-in-Class Pharma Services
We are pleased to announce that Thermo Fisher Scientific and global biotechnology company CSL have entered into a strategic partnership to help meet the growing demand for biologic therapies while also accelerating CSL’s broader manufacturing objectives.
Our Formulation of Heart and Science is the Key to Our Success
At Thermo Fisher Scientific, everything we do is made with the right balance of heart and science. Find out how Angie and our Fisher Clinical Services team went above and beyond to overcome tough obstacles in order to ensure thousands of patients around the globe received life-saving medications.
How Viral Vector Technology Is Rapidly Scaling up to Enable One Miracle After Another
The promise of viral vectors has been pursued for over two decades. But in the last few years, this transcendent technology that’s targeting over 200 diseases has finally started to create real treatments and possible cures.
How Spring Break Had to Wait a Little Longer, So a Baby Could Have a Better Shot
After a long night of packing for her family’s spring break vacation, Holli woke up at 4:40 AM Saturday morning. She noticed a text message on her phone.
How One Split-Second Decision Made a Difference for Thousands of Patients
In the world of drug manufacturing not all life-saving decisions happen in the lab. Sometimes it’s a lot closer to delivery that key moments require fast thinking.
How One Brave Patient Went from the Heart Transplant List to Climbing the Mountain Trails
“It felt like getting kicked in the chest by a horse.” That’s how Linda described the shock she received from her implanted defibrillator when she had one of her yearly “mini heart attacks.”
How Leveraging a Global Network Delivered Big Results
Mike’s team in Bend, OR was only supposed to optimize the spray drying process for a particular medication while another, much larger, facility would handle the large-scale manufacturing. However, the other facility’s equipment wouldn’t be available in time to meet the client’s aggressive IND filing schedule.
How Can Pharma Companies Save up to $45M in Early Drug Development?
Patheon’s Jennifer Therrien discusses findings of a Tufts Center for the Study of Drug Development (CSDD) study that reveals how pharmaceutical companies using a single-source outsourcing partner can achieve a net gain of $45 million in early drug development.
How a Viral Vector Got the Boost It Needed to Start Defeating an Incurable Disease
Duchenne’s Muscular Dystrophy is an incurable disease that mostly affects boys. It results from a gene defect that prevents those affected from developing normal muscle structure and function.
How a Small Non-profit Teamed up with a Global Manufacturer to Bring Their ALS Drug to Clinical Trials
Before she lost her own battle to ALS in 2003, Jenifer Estes started Project ALS, raising over $17 million dollars for the non-profit in hopes of a breakthrough in the fight against Lou Gehrig’s disease. As her family continued the quest, in 2019, they got a hit with a new compound that seemed to stop or even reverse motor nerve damage.
How a Family’s Perseverance Helped Them Reach a Seemingly Unattainable Goal
As members of the United States Air Force, Lauryn and Chris were as healthy and fit as a young couple could be. But in the world of genetics, all it takes is a couple of proteins lining up in the wrong way, and things can change in a hurry.