Cynthia A. Challener

Challenging molecules and markets are driving the development of new solutions for drug delivery.

Model effectiveness is determined by the quality and composition of the data inputs.

Multiple methods are required for detecting and removing protein impurities.

Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.

Advances in cell line engineering, process optimization, and in-vitro glycosylation are making a difference.

Early successes drive the need to overcome safety issues, increase efficacy, and address manufacturing challenges.

Developers of CAR-T cell therapies with products showing successful early-stage clinical results are currently seeking manufacturing capacity that will enable the production of the larger quantities of material needed for Phase III trials and eventual commercialization.

Two main safety issues have been identified in the early-phase clinical trials conducted to date for chimeric antigen receptor (CAR)-T cell therapies.

Cell therapy companies are attracting interest from investors, and drug companies are seeking partnerships and acquistions to accelerate development.

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

Collaborative efforts are underway between suppliers and drug manufacturers to address raw material variability.

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

mstay/Getty ImagesBiopharmaceutical manufacturing involves a series of complex unit operations linked together to provide high-purity, biologic actives with specifi

Expectations are high for rapid testing methods, but demonstration of comparability proves challenging.

Whether taking an upstream, downstream or holistic approach, there are many factors to consider when choosing viral clearance methods.

Dynamic light scattering techniques can monitor viruses and virus-like particles in their native state.

New single-use technologies and other filtration systems are beginning to address cost, throughput, and manufacturing footprint demands.

Advances in adventitious agent detection methodology are bringing benefits, but more work needs to be done.

Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.

Higher cell densities, greater demand for high-performance viral clearance, and desire for large-scale single-use technologies are driving development of filtration technologies.

Second-generation needle-free injection systems will make parenteral drug administration more convenient, efficient, and safe.

They may not be glamorous, but buffers play an important role in biopharma manufacturing.

As ADCs move through the drug-development process, different analytical methods are often required.

Ligand-binding assays are fundamental to characterizing biosimilars.

Improving efficiency, value chain, quality, and protein complexity with advanced bioprocess development.

MedicalRF.com/Science Photo Library-ANDRZEJ WOJCICKI/Henrik Jonsson/Stocktrek Images; Dan Ward

Performing degradation studies is the best strategy to evaluate toxicity risk.

Dual sourcing is one of many possible solutions to securing the supply chain.

Challenges remain for virus removal and validation.

Defining critical parameters and processing large quantities of data can be a challenge.