Achieving Product R&D and Manufacturing Success with the Right Partner

Contract development and manufacturing organizations with advanced data-driven operating environments are more likely to accelerate drug development and deliver end-to-end success

FREMONT, CA: At each stage of biopharmaceutical development, setbacks, rising costs, and extended schedules can delay the delivery of essential medications to patients. Developers can mitigate these risks by collaborating with external partners who have experience integrating various bioprocessing procedures. For instance, developers may collaborate with contract development and manufacturing organizations (CDMOs). However, designing successful cooperation with CDMOs might be difficult.

How can developers maximize their partners from the beginning of their relationship? Here are some considerations for selecting the ideal CDMO partner to establish more strategic supplier partnerships and produce superior biologics from the outset.

A key objective is to find the most intelligent spouse. This partner is compatible with the developer, possesses expertise pertinent to the developer's molecule, and can deliver transparency and visibility into operations, markets, and supply chains. And, as this essay illustrates, such a partner can carry out many crucial functions. These responsibilities are highlighted in the subsequent sections.

Accelerating the critical path effectively

Sponsors seek contract development partners to develop their innovative therapeutic antibodies to expedite investigational new drug application (IND) approval. Development and market supremacy increasingly depend on ensuring the timing of market entry.

Strategies based on a single gene expression platform are proven effective at shortening the duration of cell line creation. Standardizing a single dedicated platform facilitates efficient Phase I formulation and process development (covering upstream, downstream, and analytical technique development).

Partnering with a CDMO that provides end-to-end services is frequently the most efficient way to expedite the development and commercialization of a molecule throughout the continuum of drug substance (DS) and drug product (DP) development, manufacture, and IND submission. Partnering is an option for all biopharma companies, but it is the only choice for the small startup and virtual biopharma companies developing today's discoveries.

It is imperative to streamline the transfer from laboratories to production facilities to reduce development and accelerate clinical trials. In addition, doing so facilitates technology transfer in later phases of the program.

Increasing productivity via optimizing processes, technological transfers, and yields

Optimizing upstream and downstream bioprocesses in early development might be challenging to reduce processing times, resource amounts, and processing steps while striving to boost yields. Managing disparities in size and scale is one of the most challenging issues. During clinical development, for instance, batch sizes are often less than those of the commercial bioreactors utilized by leading biopharma CDMOs.

An important element of a successful long-term commercial partnership strategy is conducting a facility fit assessment early in the CDMO recruitment procedure. Developers and their potential commercial partners must understand as soon as feasible any equipment gaps or process modifications that may be necessary, as well as measures to expedite technology transfer. Here, it is important to examine R&D, company continuity, investment in the continual improvement of operations, financial stability, and expansion.

Companies offering a digitally advanced current good practice (cGxP) operating and manufacturing ecosystem are likely to offer superior systems and data exchange capabilities. Supported by data-sharing protocols and standard operating procedures, this essential element of collaboration between the medication sponsor and CDMO ultimately results in improved program outcomes.