Conquering Milestones Together with Your CDMO Partner
Emerging biotechnology developers increasingly rely on their CDMO partner’s efficiency, reputation and flexibility, among other skills, to get their molecules to the clinic and safely to the market. In this article, we explore the factors that contribute to a successful Developer-CDMO collaboration.
The path to clinic and commercialization of a drug is fraught with challenges. These challenges are often unique and depend on many factors – from the complexity of the molecule to how the company is incorporated, positioned and managed. Successful Developer-CDMO collaborations involve CDMO partners with a good understanding of the technical, logistical and regulatory challenges associated with a program, but can also act as a reliable collaborator, similarly invested in successfully bringing the client’s molecule to patients.
Identifying the right fit for your molecule and company
Entering a partnership with a CDMO can become challenging, if the partnership doesn’t progress or succeed as expected, with consequences for both the client and the CDMO. Critical considerations during the CDMO selection process include, experience in the particular modality, available GMP manufacturing capacity, manufacturing site location, reputation, cultural fit and corporate stability.
Ultimately, the CDMO should operate as an extension of your internal team, filling knowledge gaps and working as hard as you are to get your candidate into the clinic…quickly and efficiently.
A partner with the expertise to rapidly overcome challenges
The progression of a drug from pre-clinical development into clinical and eventually commercial production, requires a CDMO partner with the expertise and mindset to rapidly identify, diagnose and resolve challenges that could potentially delay, or at worst, terminate the program.
Issues which may arise during the collaborative development of a molecule may vary widely; they may be related to the complexity of the molecule, the technologies or processes involved. Critical to resolving these potential challenges is the expertise of your CDMO partner and the level of communication between the teams.
Manufacturing flexibility and capabilities
A candidate molecule’s behavior during clinical trials is challenging to predict. This makes capacity-planning going forward a challenge as well. These inevitabilities are best managed if your CDMO partner is flexible enough to accommodate variations in batch size and manufacturing frequency.
A CDMOs’ willingness to adapt to complex and evolving needs, as well as, early and open communication regarding potential risks are required to ensure your drug program is a success.
Celonic’s approach to partnership
The Celonic team views each partnership as a collaboration, scientific minds assembled to advance unique and complex drugs to patients in need. Our project teams persevere to understand the needs and motivations of our clients, so that together – from biopharmaceutical development to the manufacture of drug substance and drug product – we are successful in achieving the ultimate program goals.
As your first choice CDMO partner, Celonic employs highly robust bio-solution platforms, tailored processes and flexible manufacturing capacities to ensure your goals are met.