Development of methods in demand
Experience is an invaluable asset for outsourcing partners, especially as more complex method development services are in demand.
According to market research, the size of the outsourcing industry serving the pharmaceutical and biotech industries is expected to grow to $99.4 billion by 2028 (1). The demand for outsourced services is driven by several factors, such as high demand for biologics and small molecules, lack of in-house expertise, and rising costs associated with in-house development capabilities.
To learn more about the changing demand for outsourcing partners providing method development services and the trends affecting this industry, Pharmaceutical technology spoke with Jerry “Jr.” Mizell, Senior Manager, Analytical Services, Contract Metrics Services.
Pharma Tech: Could you give a brief overview of how the demands have changed over the years for outsourcing partners in terms of method development services?
Mizell (contract metrics services): Nowadays, there is a growing demand for robust methods to be developed early in the product life cycle. More and more customers want robust, robust methods in place as early as possible in the development process, and they want methods that require minimal changes as their programs move into commercial phases.
Based on the experience of Metrics Contract Services, customers also want to develop user-friendly quality control (QC) methods that help maximize laboratory efficiency in the commercial phase. Through various methods developed in recent years, dissolution, in particular, has been in the spotlight. A comprehensive approach to dissolution should produce a discriminating method that can demonstrate that an adequate drug product has been manufactured. Current client expectations also require a detailed dissolution method development report describing how the dissolution procedure was derived. This is particularly important for New Drug Applications (NDAs).
Disruptions related to COVID-19
Pharma Tech: How has the demand for outsourced method development services been affected by the COVID-19 pandemic?
Mizell (contract metrics services): While we have not experienced a direct increase in requested development services due to the COVID-19 pandemic, we have experienced supply chain issues as a result. Delays and disruptions to key supplies have made it imperative to execute method development in the most efficient manner possible to align with clinical timelines.
Choosing a method development partner with extensive experience and a proven track record becomes invaluable for clients who need to deliver treatments to patients quickly, while ensuring that key project deliverables are met.
Call for experience
Pharma Tech: Have there been any changes in expectations of what an outsourcing partner should be able to provide or accomplish with method development services?
Mizell (contract metrics services): The outsourcing partner, or contract development and manufacturing organization (CDMO), should have extensive experience in the development of solid oral dosage formulations. This experience will enable accelerated development services, especially when challenging formulations are being developed. These challenging formulations can include APIs loaded onto resin or beads and molecules that do not contain chromophores, requiring alternative detection modes.
CDMOs with experience in charged aerosol detection, evaporative light scattering detection and refractive index detection for difficult molecules can be the deciding factor in being awarded a project. Outsourcing partners with mass spectrometry (MS) capabilities are also at an advantage when impurity issues arise and identification is needed. Cost may be a priority for some programs; however, quality assurance and the ability to meet delivery deadlines are also very important qualities, which can often outweigh price differences.
Present and future trends
Pharma Tech: What other trends have impacted the development of outsourced methods in recent years?
Mizell (contract metrics services): In recent years, there has been an increase in the development of poorly soluble small molecule drug products, which can be extremely challenging when developing a dissolution method. This type of program is challenging because introducing two APIs in the same formulation and product combination, with very different physical and chemical characteristics, means that method development can take on a new level of difficulty.
From a security perspective, highly powerful APIs (HPAPIs) introduce additional challenges, as developers want to implement user-friendly methodologies without compromising the safety of lab personnel.
Pharma Tech: According to your expert opinion, what trends can we expect in the future and why? Additionally, how could outsourcing partners be better prepared for future industry demands/trends?
Mizell (contract metrics services): There should be more and more class II and IV molecules of the biopharmaceutical classification system discovered for evaluation.
Customers should seek outsourcing partners with extensive experience in the development of dissolution and the alternative detection mode in the event that a molecule does not contain a chromophore. Instrumentation should remain to current industry standards to ensure that method expectations are met.
It is also expected that future applications will call for the development of methodology for nitrosamine assessments and the ability to meet FDA (and other regulatory agency) requirements for NDA filings and current commercial products on the market. This methodology requires MS, which, if not currently available in a CDMO, can become an attractive investment to offer to clients. As with elemental impurities, this requirement will not go away and will only come under greater scrutiny over time.
1.ReportLinker, Biotech and Pharmaceutical Services Outsourcing Market Size, Share and Trend Analysis Report by Service, End-Use and Segment Forecast, 2021-2028, market report (November 2021).
About the Author
Felicity Thomas is the European Editor of Pharmaceutical Technology Group.
Supplement: Biopharma Outsourcing Innovation 2022
Pages: s12 to s13
When referencing this article, please cite it as F. Thomas, “Method Development in Demand,” Biopharma Outsourcing Innovation 2022 (February 2022).