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BioPharm International, May 2022 Issue
Emerging Therapies Face Development Hurdles
May 02, 2022
Cover Story
35
5
Complex hurdles complicate the development of emerging therapies.
Emerging Plant-based Platform for Biomanufacturing
May 02, 2022
Feature
35
5
Plant-based manufacturing technology gains mainstream edge in biopharmaceutical production.
An Evolving Approach to Drug Delivery
May 02, 2022
Development
35
5
Advances in therapeutic modalities and an increase in molecular complexity have led to the need for an evolution in drug delivery approaches over the years.
Addressing the Training Gap for Single-Use Technologies
May 02, 2022
Upstream Processing
35
5
Workforce training is crucial for biopharmaceutical manufacturing.
A Robust Quality Culture Benefits All
May 01, 2022
Quality/Regulations
35
5
Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.
Automating Cell Harvesting for Cell Therapies
May 01, 2022
Downstream Processing
35
5
Some progress has been made, but improvements are needed when harvesting cells for cell therapies.
Addressing Limitations of Sterility Testing
May 01, 2022
Manufacturing
35
5
Understanding both the challenges and solutions of aseptic manufacturing.
Perspectives on Process Analytical Technology
May 01, 2022
Manufacturing
35
5
This article summarizes industry views on PAT in bioprocess-related applications and presents a vision for the biopharmaceutical industry to achieve Industry 4.0.
Data Integrity as Current Good Manufacturing Practice
May 01, 2022
Analytics
35
5
FDA is incentivizing drug manufacturers through higher data integrity requirements.
Using a Modeling Approach to Preclinical Studies
May 01, 2022
Outsourcing
35
5
Applying modeling methods in preclinical studies can be a powerful tool for generating data and shortening development timelines.
FDA and Industry Prepare for Transition from Emergency Use Authorizations
May 01, 2022
Regulatory Beat
35
5
What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?
Dual Modality and New Analyses
May 01, 2022
From the Editor
35
5
Fresh insight is instrumental in the discussion of novel analytics.
Which Batch Size for Validation and Stability Studies?
May 01, 2022
Ask The Expert
35
5
Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.
Rapid Mass Photometer
May 01, 2022
Product Spotlight
35
5
The SamuxMP enables routine quantification of empty/full AAV capsid ratios
High-Capacity Vacuum Filtration Units
May 01, 2022
Product Spotlight
35
5
Sartorius’ Sartolab RF|BT 150–1000 vacuum filtration units provide fast, high-capacity filtration.