Regulatory Considerations Associated with Alternative Dosage Forms
Jessica Rousset, chief operating officer, CURE Pharmaceutical, highlights some key regulatory considerations developers should keep in mind when approaching alternative dosage forms.
Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
Strategic Ventures Reflect Dynamic Growth in China
Technology vendors are strengthening their positions in China as the nation emphasizes self-sufficiency in research, development, and manufacturing.
CMOs Leading the Way on Single-Use Systems Adoption
Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.
Cell and Gene Therapies Gain Streamlined FDA Oversight
FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.
Considering Alternative Dosage Forms in Biologics
Optimizing the patient experience and technological advances can positively impact adherence.
Test Methods and Quality Control for Prefilled Syringes
Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.
Is Simplification Aiding Data Integrity Compliance?
Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.
Caught in a Conundrum
Do patients get what they pay for when they demand cheaper drugs?
Process Validation Sets the Stage for Ongoing Manufacturing Quality
A properly designed validation program will detect variation and ensure control based on process risk.
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an advancement over the traditional steady-state analysis of biomolecules.
The Expanding Landscape of Commercial Single-Use Bioreactors
A look at recent investments by contract manufacturers to increase single-use bioreactor capacity.
Membrane Technology for Enhancing Separation and Purification
Downstream process equipment for mAbs manufacturing must be designed to fit technology developments in upstream processes.
Automating the Biomanufacturing Process
As automation in biomanufacturing becomes more important, so does the need to integrate process data.
BioPharm International, March 2019 Issue (PDF)
Click the title above to open the BioPharm International March 2019 issue in an interactive PDF format.
