Issue link: https://www.e-digitaleditions.com/i/1481708
16 Pharmaceutical Technology ® Trends in Formulation 2022 eBook PharmTech.com Formul ation and drug delivery that, "Hydrophobicity, high molecular weight, and high melting-point tend to correlate with poor water solubility. However, reliable prediction is only pos- sible in closely related compounds (e.g., in a homol- ogous series). Another factor to be considered is the partition coefficient. Peptides are also high molec- ular weight, but they are generally hydrophilic, and the issue for oral absorption is to reduce their hydro- philicity (e.g., using lipids)," he states. So, there are tactics and tricks that are employed to make difficult molecules druggable, but the complexity of the challenge remains. One of the promising potential ways forward to taming this beast is by applying ma- chine learning (ML). "Inherently, formulating a robust drug product has been a complex, tedious, costly, and labor-intensive process for the formulation sciences and process en- gineer group within a pharmaceutical organization," begins Dr. Vishal Rathod, as a formulation scientist at Blueprint Medicines. He continues, "Screening and selection of critical material attributes (CMAs) and critical process parameters (CPPs) for a formulation is governed by the intended route of administration (oral, topical, injectable, etc.) and [the] API's indica- tion. Depending on the respective application, a very diverse multistep multifactorial process could be involved that may impede the pace of development. Trial and error, one factor at a time (OFAT) approach, and poor reproducibility due to lack of quality-by-de- sign approach has led to failure of a potential formu- lation leading its way to first-in-human track. Lately, researchers and scientists in industry [have] started recognizing the importance of the concepts of design of experiment (DoE) and have successfully adopted them to expedite the developmental process." Dr. Rathod is at the beginning of his career and has adapted new tools for old challenges. Just as some approaches such as electrochemical synthesis can produce new and otherwise unavailable new chem- ical entities, the same could be tr ue for machine learning approaches. He also stated that "DoE is an effective tool in opti- mizing the formulation or processes with the reduced set of experiments as compared to OFAT approach. De- There are tactics and tricks that are employed to make difficult molecules druggable, but the complexity of the challenge remains. Drug Solutions Podcast: Cell Therapy Development: Advances, Trends, and the Challenge of Retention Pharmaceutical Technology presents the Drug Solutions podcast, where the editors chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. In this episode, experts from Umoja Biopharma dive into cell therapy development, including the greatest advancements in cell therapy to date, areas for improvement, the biggest trends in cell therapy development, and retention as a pain point. Cell therapies are a hot topic in the bio/pharma industry. Meg Rivers, senior editor, Andrew Scharenberg, CEO, Umoja Biopharma, and Ryan Crisman, co-founder and chief technical officer, Umoja Biopharma, discuss advancements in cell therapy to date, the biggest trends in cell therapy development, the pros and cons of developing cell and gene therapies, and much more. One of the major challenges in developing cell therapy is retention. This issue, according to the speakers, has led to the current trend for some biopharma companies to insource development rather than outsource to contract development and manufacturing organizations. The speakers also discussed scale up vs. scale out and various challenges and opportunities for autologous and allogeneic therapies. Click here to listen to the podcast.