With increasingly specialized science and technology, keeping biologics and drug development and manufacturing in-house is not feasible. Selecting a Contract Development and Manufacturing Organization (CDMO) partner is more necessary than ever.
But not every CDMO is the best choice for your company. Selecting a Contract Development and Manufacturing Organization partner impacts not only your current drug development but also other drugs you have in the pipeline. Therefore, it is of utmost importance to select the most suitable CDMO.
If you are evaluating the possibility of partnering with a CDMO, you should be aware of these common pitfalls that contract development and manufacturing organizations could make during the partnership:
- The CDMO need to bring in a large number of partners. The more players involved in the pharmaceutical development field, the greater the risk of inefficiencies, communication issues, and decision-making lags. This can lead to timeline delays, additional costs, and additional work. Using an end-to-end CDMO services can mean the difference between getting to market quickly and efficiently or not at all.
- The CDMO doesn’t collect enough information and does not know how much information is needed for a successful Biologics License Application (BLA) or New Drug Application (NDA).
- The CDMO does inaccurate supply forecasts leading to wasted resources and a months-long empty pipeline while you wait for more materials.
- The CDMO has a lack of urgency to adhere to timelines. Each stage of the development and commercialization process is critical. In addition, having a flexible CDMO that can adjust their schedule to meet customer needs is important to reduce risks in processing and bioprocessing.
- The CDMO is not willing to use anything but their own proprietary technologies. A customized approach that is based on each customer and project rather than a proprietary process or technology means a more efficient, and potentially faster path to market.
- Lack of responsiveness and transparency. CDMO companies that provide frequent check-ins, and those that receive drug sponsors on-site, provide the communication and transparency needed to keep the project moving forward, as well as to quickly address any issues that may arise and threaten timelines.
Choosing a specialized CDMO with a proven track record, customer-based services and clients who will back them up, will lead to your drug product’s success and will avoid production delays, lost funding, and even miss milestones.
Key considerations for forging a successful relationship with a Contract Development and Manufacturing Organization (CDMO)
The CDMO should focus on understanding the drug product and meeting customer requirements in early drug development stages. This leads to a higher-end product, as well as a look ahead at production problems and timeline delays.
That is why, to forge a successful relationship you have to consider:
- Your potential CDMO partner presents a timeline that meets your needs and is achievable. While shorter-than-expected timelines sound nice in theory, in reality, they can be nearly impossible to meet, especially if your CDMO hasn’t planned adequate time for potential issues, as well as testing.
- An experienced team of experts with strong early-phase development experience.The expertise of their scientists and engineers will translate into well-established processes, the ability to solve potential problems and the capacity of helping you with the complexity of regulatory reviews and clinical trials.
- Their approach to technology is forward-thinking and flexible. It’s important to find a CDMO that balances expertise in their own proprietary technologies (which could be limiting and add more time to your drug development) and cutting-edge technology innovation that could streamline development and enhance manufacturing.
- They have solid supply chain as well as the capacity to scale up. It is important that the CDMO has access to a large amount of commonly used raw materials, making them readily available when needed. In addition, if they have multiple manufacturing facilities, they are more likely to have the capacity to scale up production.
- A CDMO that is serious about operational excellence makes adjustments as soon as they are needed, managing its continuous improvement Quality Assurance program.
- Their track record speaks for itself. What type of projects and clients have they worked with in the past? A solid track record demosntrates their abilities and success in drug development.
How a Specialized CDMO Company Can Be Your Best Partner
A specialized one-stop shop CDMO that offers tailored solutions will ensure a rapid, successful transition of compounds from preclinical to market. With the unpredictability that comes with developing biologics, selecting a CDMO with the ability to provide a multi-faceted approach is critical.
Make sure your CDMO Company has a state-of-the-art facilities with the equipment necessary to offer drug development options. Also, the CDMO must operate under current Good Manufacturing Practices (cGMP), which is necessary for compliance with regulatory guidelines. CDMO companies need rigorous procedures in place and must ensure these principles are always followed to meet this standard.
The leadership team of CDMO companies is also a key component of your selection process. A CDMO with a track record in your specialty will help prevent costly mistakes, missed deadlines, and other issues.
53Biologics gathers years of experience in product development, scale-up, validation and transfer of bioprocesses. We have extensive experience in decoding biologics overexpression providing services of cell line transformation, banking and characterization (cGMP if required), analytical development, process development (USP & DSP) and batches production.
We have a proven track record in providing customer-focused and cost-effective solutions to pharmaceutical and biopharmaceutical companies. We’re ready to hit the ground running!