Cynthia A. Challener

Without an independent approval pathway for novel excipients, true pharmaceutical innovation could be stymied.

Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.

Having a clear and detailed understanding of exactly what a biomolecule entails is essential for therapeutics development.

FDA approval rate speeds up despite COVID-19 complications.

Operator, caregiver, and patient safety are at the forefront when selecting the best options and dosage forms.

A holistic approach to validation and quality assurance is essential.

Biological and analytical advances enable modern fermentation processes to deliver safe and effective next-generation medicines.

Excipients must be carefully chosen to ensure optimum protection for vaccines and live biotherapeutic products.

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

Equipment and facility cleaning is crucial, with more extensive protocols needed for some biologics.

Risk-based decision-making is impacting all aspects of manufacturing quality from raw material supply to facility inspections.

FDA relies on risk assessments, border inspections, and compliance histories in place of routine audits during the COVID-19 pandemic.

Understanding and overcoming excipient variation are crucial for successful continuous processes.

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

The correct mix of excipients is crucial to the success of fast dissolving/orally disintegrating dosage forms.

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

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

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

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

Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another.

Researching excipient grades and sources, as well as screening suppliers and materials, form the basis of programs to mitigate risk.

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

There is intense focus on the prevention and control of viral contaminants during viral vector manufacturing, which is driving the need for more accurate and powerful analytical methods for detection.

FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.

The key is to ensure that excipients only interact with APIs via desired mechanisms.

Using automation and taking a step-by-step approach can facilitate the process of selecting a top-quality cell-line source.

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.

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

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