Issue link: https://www.e-digitaleditions.com/i/1450659
Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 19 COVID-19 disruptions PTE: How has demand of outsourced services for method devel- opment been impacted by the COVID-19 pandemic? Mizell (Metrics Contract Services): While we haven't experi- enced a direct uptick in development services requested because of the COVID-19 pandemic, we have experienced supply chain challenges as a result of it. The delays and dis- ruptions to key supplies have made it imperative to execute method development in the most effective means possible to align with clinical timelines. Choosing a method development partner with vast expe- rience and a proven track record becomes invaluable to cus- tomers who need to deliver treatments to patients at speed, while also ensuring that key project deliverables are met. Call for experience PTE: Have there been changes in expectations as to what an outsourcing partner should be able to provide or accomplish with method development services? Mizell (Metrics Contract Services): The outsourcing partner, or contract development and manufacturing organization (CDMO), should have a vast array of development expe- rience in solid oral dosage formulations. This experience will allow for expedited development services, especially when challenging formulations are being developed. These challenging formulations may include API loaded on resin or beads and molecules that do not contain chromophores, requiring alternative modes of detections. CDMOs w it h experience in cha rged aerosol detec- tion, evaporative light scattering detection, and refractive index detection for challenging molecules can be the de- ciding factor in awarding a project. Outsourcing partners with mass spectrometry (MS) capabilities are also at an advantage when impurity issues arise and identification is needed. Cost can be a primary focus for some programmes; however, quality assurance and the ability to meet deliverable timelines are also very important qualities, which can often outweigh price differences. Present and future trends PTE: What other trends have impacted outsourced method development in recent years? Mizell (Metrics Contract Services): Over the past few years, there has been an increase in the development of poorly sol- uble small-molecule drug products, which can be extremely challenging when developing a dissolution method. This type of programme is challenging because introducing two APIs into the same formulation and combining products, with significantly differing physical and chemical charac- teristics, means that method development can take on a new level of difficulty. From a safety perspective, highly potent APIs (HPAPIs) introduce additional challenges, as developers want us- er-friendly methodologies in place without jeopardizing laboratory staff safety. PTE: In your expert opinion, what trends might we expect to see in the future and why? Also, how might outsourc- ing partners be best prepared for future demands/industry trends? Mizell (Metrics Contrac t Ser vices): There should be more and more Biopharmaceutical Classification System Class II and IV molecu les being discovered for eva luation. Customers should seek outsourcing partners with exten- sive experience in dissolution development and alternative mode of detection in the event that a molecule does not contain a chromophore. Instrumentation must remain com- pliant with current industry standards to ensure method expectations are met. There is also an expectation that future demands will call for methodology development for nitrosamine assessments, and the ability to meet [US Food and Drug Administration] (and other regulatory bodies') requirements for NDA filings and current commercial products on the market. This methodology requires MS, which if not currently available at a CDMO, may become a worthwhile investment to offer to customers. As with elemental impurities, this requirement will not go away and will only face increased scrutiny as time passes. Reference 1. ReportLinker, Biotechnology and Pharmaceutical Services Outsourcing Market Size, Share, and Trends Analysis Report by Service, by End Use, and Segment Forecasts, 2021–2028, Market Report (November 2021). PTE "Choosing a method development partner with vast experience and a proven track record becomes invaluable to customers." —Jerry "Jr." Mizell, Metrics Contract Services "There is an increased demand for sound methods to be developed early in the product life cycle." —Jerry "Jr." Mizell, Metrics Contract Services