APIs and Excipients

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

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

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

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

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.

Polymers and surfactants impact stability and long-term performance.

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

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

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

RSSL has added new equipment for measuring the surface area of powder particles, which is important for determining the performance of excipients and APIs.

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

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

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

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

FDA redefines cocrystals as APIs and not drug-product intermediates.

Recipharm is investing more than EUR1.2 million to enhance its small-scale GMP API development and manufacturing capabilities in Paderno Dugnano, Italy.

Pharmaceutical Technology Europe will be exhibiting at CPhI Worldwide at Stand 3G98.

Researchers develop catalysts that mediate complex transformations under conditions appropriate for commercial manufacture.

Researchers at GlaxoSmithKline report a greener and lower-cost route to chiral fluorolactams that is suitable for scale up.

Enzymatic catalysis offers pharma manufacturers a way to implement the Principles of Green Chemistry.

Recent chiral advances demonstrate promise for API synthesis.

Application of flow chemistry for small-molecule API synthesis continues to expand thanks to research efforts.

Bioprocess operations-from cell line selection to final filtration-can influence the consistency and purity of biologic drug substances.

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

Gauging the adequate level and type of screening is the challenge when identifying relevant crystalline forms.

Scale-down modeling accelerates the development of downstream biopharma manufacturing processes.

Hazardous reagents can prove to be faster, simpler, cheaper, and greener.

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.