Crystallization process development, small molecules and biological macromolecules
Downstream processes (solid-liquid separation and drying)
Solid state chemistry and solid state analysis
API (small molecule)
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.
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.
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.
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.
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.
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.
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...
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 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 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.
How a Combination of Medicines Helped One Man Take Back His Life, and Inspired Us All
On a quiet Sunday afternoon, Pete and his wife Lisa took a moment to sit on a porch swing and relax. A small piece of wood holding the chain broke and they fell backwards causing Pete to break his neck.
The stakes were high for a client who needed material for a novel drug to in order to proceed to clinical trial. With millions of dollars on the line, Jeff’s team had one shot to develop a process to scale up or risk failing the batch.
Flexible Oral Solid Solutions From Early Development to Commercial Manufacturing
Thermo Fisher Scientific provides a range of flexible oral solid dose solutions that can help you easily address your small molecule’s unique needs and challenges from early development to commercial manufacturing.
Continuous Manufacturing in Patheon’s Greenville, North Carolina Site
We are the first CDMO to build and manufacturing client product on a continuous manufacturing line. The suite, located at the site in Greenville, North Carolina, is custom built to utilize the best equipment available.
Collaboration and Knowledge Transfer Equals Success for Patients
Collaboration is an important part of our culture at Thermo Fisher Scientific and it starts with our people. Emily and Jessica are a great example of how a mentor relationship facilitates the transfer of critical knowledge to achieve long-term results.
Advantages of Softgel Technologies with Tony van Bijleveld
Tony van Bijleveld, Vice President, Sales, discusses the benefits of the recent Thermo Fisher Scientific acquisition, as well as Softgel expertise & technology to enable innovative customer solutions for patients.
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
Viral Vector Services
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
Senior Director, Global Technical and Scientific Affairs
Pre-formulation, clinical development to lifecycle management
Scientific strategic planning/problem solving
Supporting chemistry, manufacturing, and controls documentation
Formulation and development
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
Manager of Regulatory Affairs, Microbial Manufacturing Services (MMS)
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
Central nervous system and oncology pharmaceuticals
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
Development of novel viral vector-based human gene therapies
Viral Vector Services
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
Quality assurance experience including site auditing (domestic and international)
Pharmacy/pharmaceutical consultant services ad libitum
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
Registered Pharmacist (R.Ph.)