INSIGHTS ON DRUG DEVELOPMENT
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![1_76B54434E260926EE9C5174322171185]( "Vaccine Development: Strategic Approach & Response During Pandemics")
Vaccine Development: Strategic Approach & Response During PandemicsOver the past decade, outbreaks of H1N1 influenza, Sars-Cov, Ebola, and MERS have sparked ongoing conversations about strategic approaches and responses to pandemics and epidemics. Now with the spread of SARS-CoV-2 intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring these life-saving drugs to market faster without impacting product quality, safety, or efficacy.
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![Cytiva 'CY13186-Y0A2758-m02Jun20]( "The End Of End Point Assays: How SPR Is Changing Analytics In Vaccine Design And Development")
The End Of End Point Assays: How SPR Is Changing Analytics In Vaccine Design And DevelopmentDiscover how SPR can be used to accelerate vaccine discovery and development by helping overcome analytical challenges that have plagued the industry for decades.
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![istock1087218874-lab-drug]( "Successful Techniques For Progressing Biotherapeutic Candidates From Late Discovery To The Clinic")
Successful Techniques For Progressing Biotherapeutic Candidates From Late Discovery To The ClinicThe reality is that many initially promising biotherapeutic candidates never make it to commercialization. It is estimated that only 1 in 1000 preclinical candidates reach the commercial market. Why does this happen? There are many that fail due to lack of efficacy or safety, but there are also candidates that fail due to stability, aggregation, and other issues related to cell line or process issues. In our latest white paper, we help you to prepare for a successful transition to bring your drug candidate from discovery to the clinic.
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![Northway-Video]( "Overcoming Development And Manufacturing Challenges For Biologic Therapies")
Overcoming Development And Manufacturing Challenges For Biologic TherapiesWhether rapidly scaling manufacturing capabilities, shortening supply chains, accelerating the availability of emerging therapies, or reducing the risk of a pharmaceutical shortage, the pharmaceutical manufacturing platform can make all the difference in the success or failure of a biologic therapy.
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Drug Repurposing Trends — A CDMO Perspective
Dr. Anil Kane, Executive Director, Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific, reviews drug repurposing trends and shares case studies to demonstrate how a CDMO plays a role in drug repurposing and supporting the pharmaceutical industry in taking drugs to market approval.
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A Stepwise Approach To CMC Planning For A Biologics License Application
Lonza understands the challenges of designing a CMC strategy and has developed a structured and stepwise approach to planning that is tailored to our customers’ product, process, timelines, and risk tolerance.
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Biosimilars: Evolving Challenges And Considerations
Evolution of the biosimilar regulatory pathway will require manufacturers to ask critical questions about the implementation of legacy and novel technologies and procedures in downstream processing.
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Upstream Considerations For Biosimilar Development
Understanding upstream challenges during biosimilar development and creating a strategy to overcome them is critical for ensuring a high chance of success with your biosimilar product.
DRUG DEVELOPMENT SOLUTIONS
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Quick To Clinic For Biologics: Fact Sheet
The pressure to file an IND makes accelerated Phase I safety testing a priority. With the Quick to Clinic program, Thermo Fisher Scientific can deliver your large molecule drug substance for First-in-Human studies in as little as 12 months. Now you can meet important milestones – such as filing the IND – or secure additional funding with all the confidence your project needs and, we can supply. Because helping you reduce the time it takes to get your discovery to the patients who need it matters, our Quick to Clinic for Biologics is made with speed and flexibility.
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Particle Control In Biopharmaceuticals
Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.
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HyClone Cell Boost 3 Supplement
Improve productivity and cell growth in fed-batch cultures by supplementing the cell culture medium to boost nutrients depleted during culture. HyClone™ Cell Boost™ 3 Supplement provides nutrients such as amino acids, glucose, and trace elements that are suitable for research and bioprocessing applications.
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Crystallization And Solid State Chemistry Fact Sheet
Understanding the physical characteristics of API and required modification is critical to successful product development and product performance. Across a global network, Thermo Fisher Scientific integrate small molecule API, solid form science and drug product development to produce formulation enabling API to speed your product development to the next milestone.
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![patheon]( "Fill/Finish Services For Viral Vectors")
Fill/Finish Services For Viral VectorsWe offer services for new and emerging, mid-size, and large biopharmaceutical companies and research institutions developing viral vectors and viral vaccines who need Fill / Finish capacity. Our solutions are flexible, comprehensive Fill / Finish services for viral vectors that comply with current regulatory and quality requirements.
FEATURED OUTSOURCING EDITORIAL
INDUSTRY EVENTS
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Regulatory Challenges of Real-world Artificial Intelligence (AI) and Machine Learning (ML)
March 9, 2021
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Project Management in Healthcare
March 9, 2021
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Death By CAPA - Does your CAPA Program Need a CAPA?
March 10, 2021
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Best Practices in Preparation for an FDA Computer System Audit
March 10, 2021
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Dealing with the Disruptive Practitioner in a Legally Compliant Manner
March 11, 2021