Ivelisse Ruiz, Business Development Executive at Metrics Contract Services, explores three key trends influencing outsourcing and CDMO activity in 2021.
Emerging oncology therapies
There are a large number of oncology therapies in different stages of development. This comes as a result of extensive research and advances in technology in the last decade which have allowed a better understanding of the disease and identified compounds that can help prevent and/or treat different types of cancers.
A primary consideration for most celompanies working on oncology therapies is how to outsource the handling and manufacturing of these highly potent products as very few outside of big pharma have the capabilities. Risk management, misalignment of production scale or facility utilization dynamics, and availability of adequate approaches to controls and containment all have to be considered.
These kinds of products often require lower volumes meaning more flexible, smaller and specialized handling capabilities. Selecting ideal the outsourcing partner is key to the programs’ success.
Demand for mini-tablet formulations
We have seen an increase in client requests for mini-tablet formulations with a noticeable focus on pediatric formulations.
Their ease of ingestion makes them ideal for children, increasing safety, convenience of administration and patient compliance. Immediate release, delayed release and/or extended release profiles can be dosed in one capsule to achieve the desired drug delivery and they can be used to deliver two actives together. This can be especially useful if they are incompatible with each other.
Mini-tablets also offer more accurate dose delivery, with simplified and more precise filling being facilitated by the development of processing equipment with the capability to count the number of mini-tabs per dose.
They can also be formulated as floating devices to enable retention in the stomach for complete drug delivery and the small size of the tablets means faster disintegration times so they can be formulated as orally disintegrating tablets.
Time pressures and collaboration
One of the common challenges our clients and therefore Metrics faces is time. There is always pressure to begin activity as soon as possible. Our team always works with the client’s targeted milestones to drive the work and the expectations around it. Delays often occur when client’s internal requirements to begin activities at a CDMO, especially at the onsets of a partnership, are not considered. A common query is whether analytical methods for in-process testing and final product release have been adequately developed. To manage this and keep accelerating timelines, we are constantly working towards earlier and more transparent communication with our partners.
Metrics Contract Services
Given the challenges of HPAPI drug handling and the potential health and safety hazards, it is essential that your chosen partner has the proper equipment, facilities, licensing and infrastructure, to handle them.