SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions
Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.
Patient centricity has moved to the forefront of clinical trials. Direct-to-patient (DTP) services provide convenience, and lead to greater participation and retention, addressing two key challenges that face study sponsors Yourway has.
Zack Gurard-Levin, PhD, says with new innovations in assay methodologies, scientists no longer have to make sacrifices to do quality drug discovery research.
Ramesh Jagadeesan, PhD, says that while CDMOs have the capacity to support pharmaceutical companies with their analytical requirements for both small and large-scale projects, the opportunity exists to increase speed to market with innovative thinking.
RISK-BASED MONITORING – Making the Move to RBM: Improving Patient Safety & Data Quality With Real-Time Insights
Crystal Stone and Amanda Coogan indicate that in an era in which the time- and resource-intensive business model of developing blockbuster drugs has been supplanted by a push to move drug candidates through the pipeline with greater speed, accuracy, and quality, RBM and real-time data analytics are becoming a must-have for clinical trials.
Gregory A. Sacha, PhD, describes the devices used for process monitoring and how they can be used to detect end points during the process.
FORMULATION FORUM – Application of Nano-Emulsion Technology to Address Unmet Medical Needs: A Case Study of Clopidogrel IV by 505(b)(2) Pathway
Jim Huang, PhD, presents a case study on how the EmulSol technology produces stable, optically clear nano-emulsions without the use of organic solvents and with minimal use of surfactants using a high-pressure or microfluidic homogenization process.
Raza Bokhari, MD, CEO of FSD Pharma, discusses how acquiring Prismic will benefit FSD, what makes the ultra-micronized platform unique, and how ultramicro-PEA could be the answer to ending the opioid epidemic.
GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 3, Notable Drug Delivery & Formulation Transactions & Technologies of 2019
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on several notable drug delivery and formulation transactions and technologies.
Contributor Cindy Dubin speaks with several leading excipient manufacturers on how their excipient offerings are improving drug release, solubility, taste, physical characteristics, viscosity, and more for a range of molecules.
Jim Huang, PhD, says with ever increasing percentage of water-insoluble or low permeable new therapeutic entities among drug pipelines, lipid-based delivery systems, together with other main delivery technologies, have become an important tool for the development of those compounds.
THERAPEUTIC PEPTIDES – Continuous Manufacturing of Peptides Could Speed Up Development, Reduce Costs & Improve Quality
Jens Bukrinski, PhD, MSc, says the high-quality, high-process consistency between manufacturing runs and the in-line PAT analytics of the μLOT platform will enable unprecedented robustness of the manufacturing process, significantly retiring the risk of failure to supply due to non-scalability of the manufacturing process.
EXCLUSIVE ONLINE CONTENT
CanSino Biologics & Precision NanoSystems Announce Collaboration to Co-Develop a COVID-19 RNA Vaccine
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Evonik Commissions Advanced Biomaterials Production Facility for Pharmaceutical & Medical Applications
Evonik recently announced the successful commissioning of an advanced biomaterials facility in Birmingham, AL, that will support the increasing global market demand for….
Singota Solutions Collaborates With Noveome Biotherapeutics to Manufacture Promising Therapy to Treat Severe Condition in People Infected with COVID-19
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Proveris Scientific Announces Contract Test Services to Support Development of SARS-CoV-2 (COVID-19) Inhaled Drug Therapies & Vaccines
Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, recently announced the availability of contract test services to support….