Across the clinical manufacturing landscape, one priority is efficient time to market. Therefore, it is essential that drug developers and CDMO partners develop processes to allow drug products to reach the market in a pre-defined timeframe.

To accomplish this, several steps must be taken to prevent potential obstacles from arising later. By implementing comprehensive planning, we are able to provide our customers with an efficient and successful transition from pre-clinical to clinical manufacturing and beyond.

While a drug product undergoes several sensitive and crucial transitions throughout its development lifecycle, few are as critical as the shift from preclinical to clinical development. This is due to the significant uptick in production, as well as the strategic decision making related to regulatory approval, commercial production and more.

Our six-step process to filling clinical trial material has supported over 200 drug candidates in bringing them to the next development phase. This reliability is what sets us apart as a leader in fill-to-finish capabilities. The below steps support a successful transition to clinical manufacturing by anticipating hurdles long before they become a reality, allowing the drug developer to more accurately time its pathway to market.

Step 1 – Create a detailed plan

To lay the groundwork for a successful filling, we begin by establishing a realistic and well-thought-out plan addressing potential obstacles, product complexity, process design, supply chain bottlenecks, regulatory requirements and customer expectations.

Equally important is to have an experienced team in place. The knowledge, resources, and support that the clinical manufacturing team has will reflect in compliance with good manufacturing practices and small-scale study results. Along with extensive experience, the team should have a strong understanding of the API and its formulation.

Finally, within step one, the CDMO team together with the customer should determine the resources needed and additional external partners that will be required to play a role in obtaining them. If any necessary resources are challenging to obtain, it should be considered now.

Step 2 – Select and source packaging and materials

Despite packaging not coming into play until later in the filling process, understanding primary packaging options at the start is a key strategic decision. As a manufacturer of injectable drug products, we can anticipate whether the product will launch in a vial, syringe or cartridge when we consider the variables ahead of time. We can also factor in whether the product will transition to a pen or autoinjector, and if so, when planning must start for an advanced delivery system. For sponsors, it is important to confirm materials sourcing with the CDMO partner.

During this step, drug developers should acknowledge that some materials may be more difficult to source than others. We assess the timelines of all suppliers to address possible delays in delivery and potential impacts on manufacturing.

Step 3 – Finalize all contracts

Not only do the customer and its development and manufacturing partner need to be aligned on all expectations, but also the suppliers and external resources that will be involved in the clinical development process. This transparency means that all parties will share a common goal of getting the product to clinic-to-market in an agreed upon timeframe. It is important to build in enough time for the necessary collaboration amongst multiple internal and external teams. With all partners, a thorough discussion and documentation of what each stakeholder will contribute prevents later misunderstandings and delays.

Step 4 – Implement development best practices

To confirm that our filling strategy includes a comprehensive development approach, we align production processes with relevant guidelines at the start of the fill-and-finish project. Consistency in the process will streamline both clinical and commercial filling. This is also an ideal time to focus on quality by defining Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), making adherence easier for the duration of the process.

Additionally, drug developers and their partners should identify areas where more evaluation is needed and provide open lines of communication for total awareness of what will be needed to start a clinical run.

Step 5 – Align processes across teams

Evaluating API early in the manufacturing process equips us to account for line losses, filling overages, and other expected factors. It is now the time when we will confirm all filling processes have been adequately tested and evaluated. We communicate clearly with customers about cycle times – the moment when product stability at various temperatures must be considered. With this in mind, we collaborate with customers to decide how long it will take to release a clinical batch to trial sites and what resources are involved in releasing the batch. Any delay in delivery post-fill will result in high expenses for the customer.

Step 6 – Select the right CDMO partner

To find the right CDMO, ask questions like these and consider know-how, technical capabilities, and resources.

Do they have the experience of handling and processing your product?

Do they have a Quality Management System aligned with your Quality Assurance team’s expectations?

Can they source your desired packaging?

The transition to clinical development is complex and drug developers are better suited to achieve success with a strong development and manufacturing partner. By planning early, incorporating a clear chain of communication, establishing rigorous production processes, and partnering with a strong CDMO, a drug product can experience a relatively seamless transfer to clinical development.