Cynthia A. Challener

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.

A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.

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

Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.

Continuous manufacturing poses its own unique challenges to real-time monitoring of product- and process-related impurities.

Excipients and new processing techniques can make a real difference in the development of highly potent therapies.

Empty and prefilled syringes must pass a range of quality control tests.

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

With higher volumes of analytical date being generated in pharmaceutical processing, digitization and platform integration are becoming increasingly important to implement.

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.

Microbial identity data can be critical for determining contamination sources.

Antibody-based drugs offer new mechanisms of action and greater specificity.

Demand for highly potent APIs continues to rise.

Integration of new modeling and analytical tools with flow chemistry are notable trends.

Existing software tools cannot take into account the complexity of disease.

Low-temperature chemistry enables performance of more challenging and selective chemistry.

For more advanced NGS-based methods, regulatory acceptance and validation are still needed.

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

With the right excipients, formulators can control when, where, and how an API is released.

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.