Cynthia A. Challener

PAT advances are enabling improved process understanding, process control, and error prevention.

A balance must be achieved between debris and impurity removal and maximizing product quality and yield.

Facility and equipment design are important, but the team and its experience matter most.

New therapeutics modalities and the need for greater process efficiency are driving technology development.

Many antibody-drug conjugate therapies are in the pipeline; only a handful have been approved. What are the bottlenecks?

RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.

Therapies for early and late treatment and passive immunization of COVID-19 are needed and can be developed using antibodies from recovered patients.

Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests.

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

Analytical solutions are improving for raw material testing, process development, drug product release, and more.

While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.

Ensuring that viral vectors are free of viral contaminants requires a focus on prevention and control.

Accelerated timelines and small batch volumes of cell and gene therapies pose unique challenges for product-release testing.

Leveraging automation and a step-by-step approach are keys to success.

Innovation in manufacturing technologies must occur to ensure the availability of gene and cell therapies.

The evolution of cell-culture technology is driving the need for improvements in modeling solutions.

Successful process intensification with inline dilution requires effective monitoring and control.

Real-time monitoring of product- and process-related impurities remains a challenge.

The learning curve for process analytical technology has slowed widespread adoption.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

Getting the science right helps biopharma startups overcome development and commercialization challenges.

Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.

New platform technologies, advanced modeling tools, and addressing patient needs are important developments.

Leveraging vast quantities of analytical data requires digitalization and platform integration.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

New ligands are being developed to meet the separation and purification needs of next-gen biologics.

Microbial identity data can be critical for determining contamination sources.