10.24.24 -- CDER Wants Your Input On Improving Integrated Reviews

As the biotech industry has grown exponentially, so has the number of FDA clinical holds. Biotech companies need strategic planning to avoid or quickly resolve costly clinical holds.

Expedited development programs require adapting to accelerated development timelines. The challenge is to build a strategy that maintains the integrity, quality, and timeliness of the manufacturing process.

The unique characteristics of softgel capsules can play a pivotal role in the success of a drug. By addressing stability and shelf-life challenges, softgels have become a valuable tool for manufacturers.

Rare disease protocol design, vendor selection, and more can be undermined by several factors, but common-sense initiatives can improve both patient experience and sponsor initiatives.

Passive bulk shippers offer pharmaceutical companies solutions to the regulatory hurdles, supply chain disruptions, and logistical challenges inherent to global commercial pharmaceutical transport.

For ADC developers, obtaining the desired payload can be a challenge, as their synthesis is more complex than most other small molecules. Learn about a more efficient approach to payload synthesis.

Continuous processing in biopharma holds promise in improving efficiency, quality, and scalability. Watch to explore the fundamental principles and operational methodologies of continuous processing.

Read to learn in detail about biological indicators, D-value, and the differences in steam sterilization for liquid and solid loads.

No one can deny the cannabis industry is one to watch. Discover how used process and packaging equipment for the marijuana and CBD industry can fill a growing need for manufacturing equipment.

Lonza recently conducted a survey to confirm the challenges of new molecular formats, as well as identify any additional challenges in developing biologics based on them.

Gain insight into how a customized aseptic processing need was met for the safe processing of irreplaceable personalized T-cell therapies.

Characterizing mAb aggregate and fragment formation during drug formulation and establishing a QC process is crucial. Learn about a complete workflow for antibody aggregate and fragment quantification.