You deserve a CDMO partner you can trust, every step of the way. Book a meeting with us at CPHI to learn how our key elements of partnership culminate to power your success.
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.
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.
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.
Learn how CDMOs (contract development and manufacturing organizations) work with pharma companies, and the top considerations companies have when choosing a CDMO partner.
Viral vector commercialization – Part 2: Best practices in process validation lifecycle
Learn more about the robust viral vector process validation cycle, which includes various assessments and studies to ensure the safety, efficacy, and quality of viral vectors.
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.
Viral vector commercialization – Part 1: Tech transfer process for commercial viral vector manufacturing
Learn how tech transfers can help develop and manufacture viral vectors at scale, accelerate vaccine and gene therapy commercialization, and provide expertise.
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.
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.
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.
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...
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...
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.
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...
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...
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.
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...
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...
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...
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...
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.
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...
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...
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...
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.
Before you respond, think hurricanes, Nor’easters and tsunamis. Earthquakes, typhoons and volcanic eruptions. Civil unrest and war. Terrorism. A pandemic virus.
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.
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.
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.
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.”
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.
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.
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.
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.
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.
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.
Development of novel viral vector-based human gene therapies
Focus Area
Viral Vector Services
Credentials
Post-doctoral fellow at Johns Hopkins University School of Medicine
Doctor of Philosophy in microbiology from The State University of New York at Stony Brook
Bachelor’s degree in biology from Washington University in St. Louis
Senior Director, Global Technical and Scientific Affairs
Scientific Expertise:
Product development
Small molecules
Pre-formulation, clinical development to lifecycle management
Scientific strategic planning/problem solving
Early development
Clinical supplies
Technology transfer
Supporting chemistry, manufacturing, and controls documentation
Focus Area
Formulation and development
Credentials
Doctor of Philosophy from the University of Bombay, India
Master of Business Administration from Richard Ivey School of Business, University of Western Ontario, Canada
Post Doctoral research at the University of Cincinnati
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.
Pre-formulation, formulation, process development, scale-up, tech transfer, commercialization
Phase appropriate dosage forms for preclinical and clinical studies
Solubility enhancement technologies
Amorphous solid dispersions by spray-drying, hot-melt extrusion and complexation
Size-reduction and lipid-based systems
Oral modified release
Multiparticulate and osmotic delivery
Matrix tablets
Lipid modified release
Injectable drug delivery
Formulation development for solution and lyophilized vials for small molecules
IV and depot formulations
Powder-filled vials
Technology transfer
Focus Area
Commercial manufacturing
Credentials
Doctor of Philosophy in inorganic chemistry from Ohio University
Post-doctoral Fellow and Visiting Assistant Professor of chemistry at the University of Idaho
Master’s and Bachelor’s degrees in chemistry (polymer and materials) from Texas State University
Highly experienced in supply chain with a particular focus on sales and operations planning, transportation and logistics management, and system enhancements including SAP
Certified in production and inventory management (American Production and Inventory Control Society)
Multi-functional leadership experience in manufacturing, quality, and technical areas within pharmaceutical GMP environments
Focus Area
Logistics
Credentials
Bachelor’s degree in production and operations management from Ohio State
Microbial control, Product Quality microbiology, and Sterility Assurance for investigational new drug and marketing applications
Developing, editing and reviewing regulatory submissions, including reviews as a health authority assessor
Regulatory intelligence and interpreting regulatory guidance
Focus Area
Viral Vector Services
Credentials
Sallie Rosen Kaplan Post-Doctoral Fellow, National Cancer Institute, National Institutes of Health
Doctor of Philosophy in Microbiology and Molecular Genetics from Harvard University
Bachelor’s degree in Biochemistry and Molecular Biology from Michigan State University
Quality assurance experience including site auditing (domestic and international)
Pharmacy/pharmaceutical consultant services ad libitum
Focus Area
Softgels
Credentials
Pre-med/pharmacy degree from Indiana University South Bend, IN
Bachelor of Science, Pharmacy from Purdue University School of Pharmacy in West Lafayette, IN
Studied diabetes education and anticoagulation therapy
Immunization certified
Registered Pharmacist (R.Ph.)
Highly experienced in the development of cell lines, media, and culture conditions for the production of recombinant proteins and naturalmetabolites, as well as bioreactor operation, scale-up, cGMP manufacturing and technology transfer
Research experience and skills include both mammalian cell culture and microbial fermentation (bacteria, yeast, filamentous fungi), process development, cellular physiology, and perfusion culture
Focus Area
Biologics (large molecule)
Credentials
Doctor of Philosophy in microbiology and molecular genetics from Rutgers University, NJ
Master of Science in microbiology and molecular genetics from Rutgers University, NJ
Bachelor of Science in biological sciences from Cook College, Rutgers University, NJ
Crystallization processes for commercial applications
Materials science expert
API development
Commercial manufacturing
Focus Area
API (small molecule)
Credentials
Doctor of Philosophy in synthetic organic chemistry from the University of Cambridge, U.K.
Bachelor’s degree in pure & applied chemistry from Strathclyde University in Glasgow, U.K.
Manager of Regulatory Affairs, Microbial Manufacturing Services (MMS)
Scientific Expertise:
Regulatory strategy for marketing of controlled substances, new molecular entities, and new chemical entities
Regulatory intelligence and interpretation of regulatory guidance
Developing, editing, and reviewing regulatory submissions
Cell and gene therapy CMC expert
Microbiology and immunology
Viral pathogenesis
Medical technology
Central nervous system and oncology pharmaceuticals
Focus Area
Biologics
Credentials
Jean B. Kempner Postdoctoral Fellow and Ruth L. Kirschstein National Research Service Award Institutional Research Training Grant recipient, Doctor of Philosophy in Microbiology and Immunology from University of Texas Medical Branch, Bachelor of Science degree in Medical Technology from University of Texas MD Anderson Cancer Center School of Health Professions, Bachelor of Science degree in Biology from Texas A&M University Corpus Christi
Pre-formulation, formulation, process development, scale-up, tech transfer, and commercialization
Solubility enhancement technologies
Amorphous solid dispersions by spray-drying
Hot-melt extrusion
Size-reduction
Lipid-based systems
Complexation
Oral modified release
Multiparticulate delivery
Osmotic delivery
Taste masking
Fast-dissolving dosage forms
Lifecycle management
Designing novel drug delivery systems
Nano-milling
Process miniaturization
Process development and scale-up
Novel process design & implementation
Design of experiments
Technology transfer
Focus Area
Formulation and development
Credentials
Doctor of Philosophy in chemical engineering from the University of Colorado in Boulder
Bachelor’s degree in chemical engineering from the Indian Institute of Technology Madras (Chennai)
Characterized and model drying processes, unit operators
Fluid bed driers
One-pot granulators
Tablet coaters
Focus Area
Oral solid dose
Credentials
Doctor of Philosophy and Master’s degree in chemical engineering from Rutgers University
Bachelor’s degree in engineering, chemical engineering from The Cooper Union for the Advancement of Science & Art
Ultra-cold and cryogenic storage and biorepository
secondary packaging and labeling
Global cold chain logistics network operation
Supply chain visibility and real-time monitoring
Chain of identity and chain of custody
Focus Area
Advanced Therapies
Credentials
MBA from Northwestern University, Kellogg School of Management
MA in Biology from Smith College
BS in Biochemical Engineering from East China University of Science & Technology
State-of-the-art Plainville site (290,000 ft2) designed for end-to-end viral vector services, from process development to commercial manufacturing, with unparalleled capacity and capabilities to meet market demands.