Next-Gen Therapies Drive Development Technologies
The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.
Temperature and Relative Humidity Control to Reduce Bioburden in a Closed Cell Processing and Production System without Disinfectants
Controlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants.
Meeting the Demand for Lipid Excipients
Contract manufacturers play a key role in the production of lipid nanoparticles for RNA vaccines.
Cell-free Expression Systems Pose Cell Culture Alternative
Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.
Innovative Chromatography Resins Can Improve Purity and Quality
Recent innovations in chromatography resins offer promising advantage in downstream bioprocessing.
Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.
Innovations Meet Growing Demand for Prefilled Syringes
Container and equipment innovations expand applications.
Development Strategies for Cell and Gene Therapy Methods
The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
Developing a Method for Success through Partnerships
Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and development time efficiencies.
Pandemic Highlights Need for Advanced Pharma Manufacturing
Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.
A “We are the World” Vaccination Effort?
Bio/pharmaceutical manufacturers have made a good first step toward global vaccination through pledging doses at no- to low-profit rates.
From the Chairman: Technology Advances Foster New Therapies
Innovation drives the development of emerging drug modalities.
The Facts About Filing Drug Applications
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.
