11.18.20 -- Solving Drug Product And Drug Substance Challenges For Pharmaceutical Development And Manufacturing

How can pharma companies minimize project risk and development costs, select the right excipients, equipment, and process technologies to complement their API and dosage form, and hopefully also enable higher drug loadings and improve stability? Following are five key factors that companies should keep in mind to help ensure their path to solubility enhancement is as seamless and as low risk as possible.

After more than 25 years of commercial use with almost 20 parenteral drug products, lipid nanoparticles (LNPs) are having a breakout moment. While LNPs are now a proven drug delivery technology to penetrate target cells and ensure release for reliable systematic or local delivery, their true market potential as a gene and cell therapy enabler has only become clear to many since COVID-19.

As many pharmaceutical companies have multiple APIs in their clinical pipelines that are highly potent, it is becoming increasingly common to select a preferred CMO partner. This article discusses the key growth trends for highly potent APIs (HPAPIs) and the criteria pharma companies should use to select a CMO partner.

Over the last decade, the potential of fermentation-based manufacturing to create proteins in a sustainable, scalable, and cost-effective process has expanded considerably. Many biotechnology, food, and advanced material developers are now seeking to develop and commercialize their protein-based products utilizing microbial fermentation processes.

Cell culture media used in biopharma production have come a long way in recent decades. Arguably the single biggest change has been the shift from complex animal-derived compositions to chemically defined media that are safer, more consistent, and deliver higher levels of performance. This article discusses key solubility, stability, and other challenges that many biopharma companies still face.