Cynthia A. Challener

Unique solutions are required to protect inherently unstable messenger RNA.

Impurities and batch-to-batch variability present the biggest challenges.

Lipids aren’t the only important ingredients influencing stability and in vivo performance.

Key challenges posed to autologous and allogeneic treatments could be resolved by in-vivo CAR-T gene therapies.

Topical eye treatments can be beneficial for patients with a growing array of eye diseases, but only if taken appropriately.

In vivo CAR-T gene therapies could resolve challenges faced by autologous and allogeneic treatments.

Inhaled vaccines must resist degradation and penetrate the mucosal lining in the airways and lungs.

Unique solutions are required to protect inherently unstable messenger RNA.

High-concentration injectable formulations present unique challenges.

Production of viral vectors requires a holistic view of the product, including its manufacturing process and its ultimate end use.

Numerous benefits will eventually lead to large-scale applications in pharmaceutical manufacturing.

API permeation into the skin modulates the efficacy of topical treatments.

Further advances in construct design and manufacturing scalability are still needed.

Biosimilar data analysis must demonstrate a correlation between structure and function.

Lack of toxicity data and poor physicochemical properties must be overcome.

The right processes used with the right excipient combinations address evolving formulation needs.

Inhalation formulations are complex, and empirical data are essential for realizing optimal solutions.

Although not easy to do, it is essential because excipients can affect drug-product safety and efficacy.

Bacteriophages could be crucial weapons in the fight against antibiotic-resistant bacteria.

Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.

Interest in natural phytochemicals or synthetic derivatives of cannabinoids has risen.

The multispecific analysis of biologics is a complex task that requires appropriate strategies.

Dosage form and patient needs drive excipient choice.

Polymeric amorphous solid dispersions are the most commonly used technology, but amorphous APIs remain inherently unstable.

Simple, inexpensive real-time analytics are urgently needed for high value products.

SEDDS and SMEDDS improve solubility and permeability while expanding efficacy and applicability.

Drug makers are going beyond continuous improvement and green chemistry to increase the sustainability of small-molecule manufacturing.

Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.

Consistency, robustness, and understanding of the API and controlled-release excipients are essential for successful drug dosing.

Data sharing facilitates traceability, transparency, and accuracy while driving efficiencies and boosting quality of active pharmaceutical ingredients.