Sound CDMO Considerations for Biotechs: Integrated Services, Early-Phase Technologies, Transparent Project Management & Robust Platforms

Chemistry Today Panel Discussion

Panelist Commentary by Dr. Stephen Houldsworth, Sr VP, Global Head of Small Molecules Platform

• How do you align your technical team’s input when biotechs bring discovery-stage molecules with limited characterization or formulation data?

It all starts with the customer’s RFP. Our technical teams first explore the customer’s package and put together a proposal which includes core elements that we consider essential to the success of the program. These may be related to the safety of our operators, familiarization of the process, or the quality of the product and compliance with the Good Manufacturing Practices involved – for us these are non-negotiables.

We will then suggest optional elements with a business or scientific rationale as to how they will advance the asset or reduce the risk of the program, either from a manufacturing point of view or a regulatory perspective. We then present the full RFP to the customer, usually with strong suggestions regarding the optional elements which are based on our track record of experience and ability to anticipate their needs – but at the end of the day it is the customer’s decision.

In order to address limited characterization and formulation data, it helps biotechs tremendously to choose a CDMO with early-phase solid-state API and bioavailability enhancement Drug Product services to address these issues early on.

• How do you plan internal resources and capacity when handling multiple biotech clients in parallel without compromising timelines or quality?

It is always a juggling act working with multiple biotech clients but our global network of Facilities, Site Project Managers, Technical Teams, Platform Directors and Sales Reps work together seamlessly to coordinate multiple biotech projects in parallel. We recommend that biotechs work with CDMOs that have large enough Process Development and Analytical resources to ensure there is always sufficient bandwidth available to accommodate shifting priorities.

• How do you communicate timeline risks and mitigation strategies effectively to biotech partners?

Open communication is key, along with presenting options/solutions as challenges come up. Indicating where points of concern could impact timelines at the outset of a project is an important part of the process, as the customer may actually have valuable information they have not shared previously which can shed light on the situation or explain why they choose a particular path. These details are often crucial to informing a sound strategy.

We often present mitigation strategies up front, but since budget is an ever-present concern for the biotech customer, we usually start with the basic strategy and adjust as needed on the journey. We often find the biotech customers’  least considered aspect of planning centers around the final solid-state form of the API, and how this will impact their drug product aspirations.

Fortunately, CordenPharma has in-house Centres of Excellence for API Solid-State and Drug Product Bioavailability Enhancement considerations that address these decisions when the need arises. We encourage customers to take advantage of these services up front during development so we can maintain timelines, but we also involve the group later as challenges begin to transpire during drug product development and production.

• What practices do you follow to ensure transparency, accountability, and traceability in complex development programs?

Utilizing our Smartsheet project management system, we have created a one-stop portal for all project-related details, where customers can follow along with the project progress in real time and find all project meeting minutes, action item lists, documentation trackers and of course, the all-important timeline, stored in one place.

Through this tool the customer has the most transparent access possible to their project within our systems. When multiple sites within our integrated network are involved to execute both Drug Substance and Drug Product manufacturing via our integrated supply offering, or when customers take advantage of our Centres of Excellence to solve potentially complex issues, the process can become very complicated from a project management perspective.

So here, our Global Project Management systems become extremely beneficial to biotechs by creating one common point of contact. Having that one central resource to coordinate the activities between multiple sites and priorities relieves them of a significant burden. It also creates one common vision for the project internally, which is obviously aligned with the customers’ vision.

• What tools or digital platforms (e.g., dashboards, LIMS, collaborative portals) have improved real-time visibility and engagement with biotech clients?

The implementation of our common global Smartsheet Project Management system provides our customers with the most efficient access possible to our systems to track and monitor the progress of their project. Updated in real time, the system provides a common, one-stop-shop approach to project updates, project meeting minutes, timeline updates, documentation trackers, upcoming milestones and action logs. The system is obviously protected so that only the customer can securely view the project externally, but internally the full project team has access to update it as the latest information becomes available.

• What’s your approach to method development and tech transfer when receiving incomplete or early-phase packages from biotechs?

When we sign on a new client, we do so on the understanding that we are here to provide whatever expert CDMO advice possible, since it’s in both parties’ interest that the program is successful. In many cases, this may be a partner’s first or second asset to be taken into the clinic, whereas in our case, we have decades of experience helping biotechs with incomplete or early-phase packages find effective method development to bring their projects through clinical phases. Some clients take advantage of that expertise, which an experienced CDMO should offer freely, and in other cases they may  decide to hire CMC experts – so often a working partnership gets formed to help shepherd the asset into the clinic.

An important aspect of successful tech transfer to consider when selecting a CDMO is their facility network. Does it provide seamlessly integrated, global services that alleviate distractions and potential roadblocks to successfully meeting timelines?

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