Small-Molecule Matters: Integration in Drug Development

Sponsored by Cambrex

September 8, 2020

How a collaborative approach between small and large drug developers with the right CDMO can overcome critical challenges to achieve greater efficiencies in quality, time, and cost – at every stage of the small molecule drug lifecycle.

Sarah Bethune, PhD
Sr. Director of Pharmaceutics and Formulation Development
Cambrex


Advances in drug development and manufacturing, combined with stricter regulatory requirements, has enabled safer drug products to enter the market with higher quality and smaller, yet more efficacious, doses. However, demand to continually reduce costs and processing times has added new layers of complexities to the drug development process. As a result, many of today’s drug developers are turning to outsourcing for the full lifecycle of small-molecule drug products to achieve greater efficiencies in quality, time, and cost.

Contract development and manufacturing organizations (CDMOs) can sustainably support complex drug development processes for the life of the process, allowing small and large drug developers to leverage their strengths and focus on continued innovation. But to successfully align with a CDMO, a collaborative approach is necessary. A focus on communication and integration is paramount to ensuring that drug processes will scale and transfer smoothly and operate accurately for the life of the process.

When working with a CDMO on a small-molecule drug development project, it is critical that each phase of the project is clearly defined and documented. All parties must share data and have the same expectations to ensure that projects only advance when the appropriate criteria have been met.

Phasing Projects for Success

Cambrex is a dedicated small-molecule CDMO with a unique approach to aligning with clients using a well-defined set of phases to keep projects transparent and timely. A breakdown of the phases follows:

  1. During the Evolution and Decision Phase, a request for proposal is received and used to guide an open discussion about the project objectives. Cambrex applies the customer information to carry out feasibility checks and site selection activities to create a comprehensive work proposal.

  1. When a proposal is approved, the project moves to the Planning Phase, where project terms are established, and a scope of work is laid out that accounts for all the factors of the project. 

  1. During the Preparation Phase, plans are reviewed to ensure appropriate levels of compliance are met throughout the process. Governance materials and processes, including reporting protocols, change management procedures, raw materials procurement plans, analytical methods, and transfer protocols are defined. A quality risk matrix will also be developed to establish a risk-mitigation strategy. 

  1. In the Execution Phase, it is time to kick off the process development and manufacturing work with all information recorded appropriately by development phase. Batch data is recorded, tracked, and analyzed as the process scales.

  1. Often the most time-intensive phase is the Assessment Phase. All generated batch data will be used to guide the next steps, and appropriate documentation, including validation reports, regulatory documentation, and tech transfer reporting will be completed. The risk-mitigation strategy is re-evaluated in this phase to identify any realized risks and determine if there are any persistent or unexpected quality or technical concerns to address.

Full Cycle Risk-Management to Ensure Quality

Once the Post-Execution Phase is completed, a project is considered ready for the supply of clinical materials or transfer to another production site within Cambrex for commercial production. Even as a process enters these later stages of drug development, Cambrex continues to review and augment the risk management strategy if necessary, so that nothing is missed.

The risk matrix covers both technical and administrative risks, including hard-to-find raw materials, or other potential supply chain, logistics or support-team-related issues. Each risk is identified as low, medium, or high and is mitigated, as appropriate.

The value of this phase- and risk-based approach to small-molecule drug development can be seen across the life of the project. Because it is cyclical, the process can be evaluated at any point in time to ensure that objectives and deliverables are being met. If there is ever a need to pivot, whether for the purpose of improving efficiency/productivity or due to the need to meet new regulatory requirements, the team is ready to make changes swiftly.

The Changing Landscape

Now more than ever, as COVID-19 challenges the pharmaceutical industry, business continuity is critical. Due to extensive planning and cutting-edge systems, Cambrex has been able to rapidly pivot and address the changing business landscape. Extensive use of virtual communication systems has enabled consistent meetings and viewings of in-plant operations. And just as in times of “normal” business, lines of communication are kept open and clear.

Direct and transparent lines of communication enable a truly collaborative approach to each customer project, regardless of the business landscape. This high level of transparency and communication are critical to the phase-based approach to small-molecule drug development that sets Cambrex apart from other CDMOs.

Working to be THE Small-Molecule CDMO of Choice

The team at Cambrex has decades of process experience and continually invests in technology and capacity to give customers exceptional support. Combined with a global network of research and development (R&D) and production facilities, Cambrex is ideally positioned to support clients with even the most complex small-molecule projects. And with expertise at every stage of the drug development process, the team can efficiently overcome challenges and recognize opportunities throughout the life of the drug development process that benefit customers.  

Cambrex project managers are invested in each project and can deliver clear, actionable updates to customers at any given point in their process, providing peace of mind. The whole team has knowledge of the latest regulatory guidance and hands-on experience working closely with regulatory agencies from pre-clinical development through to product approval and commercialization. By applying a well-defined and cyclical phase-based approach, complemented with cutting edge technologies, ample capacity and a continuous improvement mindset, every small-molecule drug development project becomes more streamlined and secure.

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