Cynthia A. Challener

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.

Complex protein formulations require multiple analytical techniques to achieve full characterization.

Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

CMOs/CDMOs that are easy to work with, have demonstrated performance track records, and plan for the future are preferred.

Highly complex APIs developed to treat rare and orphan diseases present big technical questions for contract developers.

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.

FDA looks to achieve near-record level of new drug approvals following slowdown in 2016.