Cynthia A. Challener

Formulation and excipient advances address taste masking concerns to improve medication adherence in pediatric, geriatric, and other special patient populations.

For many processes involving hazardous chemistry, running in flow mode has safety and economic advantages.

The use of approved platform technologies can reduce the time and cost required to generate new vaccines.

Taste masking increases drug acceptability and medication adherence in pediatric, geriatric, and other special patient populations.

CDMOs sharpen skills for identifying API potency risks and establishing safety and handling procedures.

Compared to traditional drug discovery approaches, drug repurposing, repositioning, and rescue can be faster and cheaper.

CDMOs have established strategies for handling new chemical entities with unknown biological activity.

Media manufacturers improve processes and technologies to reduce risks and improve quality and consistency, while managing costs.

Drug repurposing, repositioning, and rescue can be faster, cheaper, and target more diseases than traditional drug discovery approaches.

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.

Cannabinoids have potential to treat a variety of diseases, but pharmaceutical companies must first develop cost-effective ways to access pharmaceutically pure materials without marijuana cultivation.

Polymers and surfactants impact stability and long-term performance.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

Efficient synthesis of complex cannabinoids is possible while avoiding marijuana cultivation.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

Advances in equipment, instrument, and control systems are enabling online monitoring of continuous API manufacturing.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

Researchers continue efforts to overcome challenges of effective oral delivery of biologic drugs.

Advances in process analytical technology have been achieved, but significant challenges remain.

Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.

Meeting evolving global requirements for excipients requires close collaboration between pharmaceutical companies and excipient suppliers.

Mass spectrometry plays and important role in advancing on biologic drug development and manufacturing, but limitations still exist.

Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.

Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.

FDA issued approvals for less than half the number of new drugs in 2016 compared with 2015.

Alternatives to expensive palladium catalysts are gaining acceptance for commercial API synthesis.

As of mid-December, less than half the number of new drug approvals were issued by FDA in 2016 compared with 2015.

Previous hesitation by pharma industry to use cocrystals may change with FDA’s new guidance that classifies cocrystals APIs.

Non-precious-metal catalysts are increasingly employed for commercial API synthesis.

Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing models.