Whether your company is scaling up production or onshoring, tech transfer of an oral solid dose (OSD) to a new contract manufacturing partner involves a high level of complexity, with inherent technical and regulatory risk. Hovering in the background, meanwhile, is the business risk of unexpected delays.

A lot takes place between signing a contract and starting commercial-scale production. What often goes unrecognized, however, is that most OSD tech transfer delays don’t happen on the production floor. They happen in the first 30 days. Here, we look at five hidden risks that can lead to tech transfer holdups, and how to avoid them.

Poor Risk Assessments and Unrealistic Timelines

When a tech transfer to a contract development and manufacturing organization (CDMO) goes poorly, the root cause is often inadequate risk management, which produces timelines that can't be met. In the first days of a project, the CDMO’s tech transfer team needs to evaluate method transfer readiness, identify gaps, and track lead times for all materials and components, including for packaging. A rigorous risk assessment equips the team to create an accurate transfer plan with a realistic schedule.

Incomplete Knowledge Transfer

Incomplete knowledge transfer can doom tech transfer. Successful knowledge transfer relies on thorough communication between staff with equivalent backgrounds. A CDMO should have a multidisciplinary tech transfer team that can clearly communicate with the experts from the client’s R&D, analytical, manufacturing, quality assurance/quality control, validation, and regulatory affairs groups.

The client's process development and manufacturing experts possess a wealth of product and process knowledge that goes beyond what can be listed in batch records and development reports. This direct communication, backed by a structured tech transfer checklist, will ensure the CDMO team captures that key information.

Lack of In-House Analytical Laboratories

If a CDMO outsources analytical method development and validation and testing, that can slow down tech transfer. For oral solid doses, a wide range of tests is needed for comparability testing of drug product produced by the CDMO and client. In particular, a discriminating dissolution method is critical to distinguish material or process changes that can affect drug release characteristics. A CDMO should also have the capability to run in-process and product release testing, as well as stability studies, which involve longer time periods. In-house analytical capabilities at the CDMO will avoid delays across all tech transfer steps.

Delays or Problems in PPQ Batch Manufacturing

Process performance qualification (PPQ) is a critical stage in the process validation of a transferred manufacturing process. Missing a PPQ batch manufacturing date can cause extensive delays.

The CDMO tech transfer team must prepare a thorough plan to ensure the project proceeds according to schedule, so that the method transfer, equipment qualification, and engineering batch are completed before the dates slotted for the PPQ batches. If problems arise during any of these steps, an experienced team knows how to quickly troubleshoot problems to stay on track and prevent the need to reschedule PPQ batch manufacturing.

De-Risking Tech Transfer Starts Early

Oral solid dose tech transfer is complex, but the delays that derail it are preventable. Rigorous risk assessment, complete knowledge transfer, and disciplined PPQ planning, along with the right in-house capabilities, are keys to avoiding delays. A CDMO that invests in this groundwork from day one gives your project the best chance of staying on schedule, from the first 30 days through commercial-scale production.

De-Risk Your Tech Transfer. Contact UPM today to find out how our tech transfer process can ensure the success of your program.