The role that CDMO APIs play in new drug development

Authored by: Saurabh Gurnurkar- Executive Director, Uquifa

The role that CDMO APIs play in new drug development

As global economies grow, and healthcare provisions and insurance mechanisms expand, demand for local and imported pharmaceutical products surges, as it has been doing for the last couple of decades. In the past few years, the pharmaceutical industry has seen rapid growth driven by the growth of small molecules’ innovations, complex Active Pharmaceutical Ingredients (APIs) and the increasing need to optimize available resources. Many specialty and biotech organizations are now relying on external service providers to minimize the costs of manufacturing and in-house development required to develop molecules for new drugs and their subsequent clinical trials.


The role of a trusted CDMO, with long-standing record of regulatory compliance and efficient project management, can help tremendously in reduced time and costs, and this has become the top priority for the early phase development and commercialization of small molecule APIs. With rising demand and approvals required for new drugs, an external collaboration with CDMOs helps in driving a successful and robust clinical development plan for a new drug molecule. CDMOs closely work with companies who want to pursue upcoming innovations in medicines, help cope with shortcomings of internal lab-to-manufacturing scale-up.


What matters most

Getting a new drug to commercial manufacturing is also complex and costly due to the very stringent drug manufacturing regulatory mechanism. A strategic CDMO partner who can uphold a strong product manufacturing approach can positively influence timeline, quality, and costs of bringing the drug to market. The ability of a CDMO to lay down good quality audits, knowledge of equipment, packaging configurations, and good capability building of resources, helps in determining a competent CDMO partner.


Defining the deliverables of the project in advance helps CDMOs to work through a realistic timeline that can work mutually for both parties. It is always advisable for companies to start the clinical study responsibilities early on to combat unforeseen challenges that require more time. A thorough safety and risk analysis procedure should be administered at an appropriate time with documentation that adheres to the rules and regulations set forth by the regulatory authorities.


The long-term efficiency aspect stems out from flexible research and advancement of the project. UQUIFA, as a small molecule CDMO, focuses on understanding the client’s requirement and ensures aligning all the crucial aspects from the beginning of the partnership relentlessly providing niche expertise required to execute the project.


Flexibility in a CDMO is the key to ensure speed of tech-transfer which is a true litmus test for CDMOs which can help a company chose between competing analytical strategies, manufacturing technology and knowledge for improving productivity. A CDMO must have bolt-on capabilities with efficient chemistry which translates into adding new capabilities that the specific molecule development may require quickly.


Tech transfer

The most important thing to be considered while determining a CDMO competency is their technical knowledge along with adequate expertise to accomplish the drug development till commercial scaling. This also includes experience for drug delivery systems, efficient teams, facilities, and production capabilities. The relationship between a CDMO and the company also depends on influencing aspects such as transparent communication, involvement at every step, and support while dealing with challenges. With over 80 years of experience developing and manufacturing small molecules, UQUIFA has not only the knowledge and tools to successfully execute transfer activities but also the track record of success with several crucial drug commercialization.


Partnering with a CDMO that has the skills and capabilities to execute a successful tech transfer is critical, as this complex, multi-step process helps lay the foundation for the new drug’s journey through to commercialization. Therefore, a company should select one who meets your checklist of must-haves as well as provides the open communication and transparency needed to establish the most important component of your relationship — trust.