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Drug Substance , Translational Pharmaceutics

Small Molecule Drug Substance Development – Part 3: Once your drug substance has been manufactured, how do you successfully bridge into drug product development?

People walking through a hallway and working in a pharmaceutical manufacturing setting

In the previous blog post in this three-part series, we discussed how to streamline the manufacturing of your drug substance. Read part 2 in the series: How do you streamline manufacturing of your drug substance? 

After streamlining drug substance manufacturing, the next challenge is formulating your drug substance (active pharmaceutical ingredient [API]) with other inactive ingredients (excipients) into a finished dosage form (drug product) for clinical trials.

The interface between drug substance and drug product is a key part of the drug development pathway. Drug substance and drug product development are often carried out by different organizations, which can be inefficient and costly, leading to poor knowledge and material transfer, and delivery delays. The complexity of today’s drug molecules and target product profiles (TPPs), and the timeline pressures that drug developers are faced with, exacerbate these challenges.

At Quotient Sciences, we address these challenges by providing fully integrated drug substance, drug product, and clinical testing services, all within one organization.

This means that we can manage drug substance and drug product development in parallel and develop manufacturing processes that are controllable, robust, and scalable with minimal risk. This ensures that when we develop a drug product and supply it to our customers, there is no need to re-run studies as they move downstream through successive clinical stages. This saves drug developers time and money and ensures significant value to the end product.

For integrated drug substance and drug product projects, our cross-functional project team members bridge the gap between drug substance and drug product, shortening program timelines by sharing knowledge and materials from project initiation and continuing to work side by side for the duration of the project, ensuring that nothing gets missed along the way.

Our highly skilled scientists have decades of experience working in manufacturing at larger scales and know what a process should look like for downstream success. With closely aligned workstreams, our process chemists work alongside analytical and solid-state chemists to ensure rapid development and optimization of the drug substance. Our formulation scientists and solid-state chemists together provide clear and unambiguous data for optimizing the drug substance form, leading to rapid dosage form design and drug product manufacturing.

Each cross-functional project team is overseen by a single project manager, who seamlessly manages the end-to-end process, provides regular status updates, and ensures timely project delivery for our customers. 

We work with clients of all sizes, from small biotech companies to large pharmaceutical companies, tailoring our services to meet their specific project goals.

For small biotech companies, we provide high-quality data packages that have been designed by people who know exactly what large pharmaceutical companies value and expect, leading to a smoother transition and a higher value for the transaction. For large pharmaceutical companies, the ease of material transfer reduces overall risk and shortens the time for the clinic to know whether their formulation is successful to move forward with.

The integration of drug substance and drug product services within one organization has multiple benefits, including ease of material transfer, seamless coordination, and knowledge sharing between drug substance and drug product groups, which enhance the likelihood of clinical success and reduce the overall risk. However, the ultimate benefit is a significant reduction of drug development timelines from candidate selection to clinical development. 

On average, drug development timelines are reduced by 3–6 months by utilizing an integrated approach, which translates into significant R&D cost savings and gets new medicines to patients faster.

This is part three of our three-part series focused on scaling drug substance.

Continue reading part 1: How do you design a safe and scalable synthetic route for your drug substance?

Continue reading part 2: How do you streamline manufacturing of your drug substance?

Learn more about our drug substance capabilities


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