As the number of therapeutic molecules in development has increased during the last years, the number of contract development and manufacturing organizations (CDMOs) has also significantly increased. With more CDMOs to choose from, pharmaceutical companies must prioritize CDMO selection criteria to find the right partner for their new drug development project.
Developing a new drug takes time—an average of 10 to 12 years—and can cost upward of $5.5 billion dollars and considering that many molecules and new drugs fail, the selection of the right CDMO partner is critical.
Finding the Right Biologics CDMO Partner
Before you start searching for a Biologics CDMO partner, you have to answer the following questions:
- Will you be working with a CDMO for discovery and drug development all the way through approvals and commercialization?
- Will your work with a CDMO for commercial manufacturing begin with preclinical development or with clinical research?
To help you, below we show you the 4 criteria you have to consider when you want to select a CDMO:
Your Drug’s Development Stage
Selecting the right CDMO partner depends heavily on the stage of drug development you are in. It is not the same if your drug is in discovery phase or to regulatory review and approval.
It is a key deciding factor for whether or not you will move forward with a CDMO or than keep it in house.
The stage of your drug development will impact the amount of material needed, which may impact the choice of CDMO based on their capacity and facility space to produce the desired amount. In addition, an experienced DCMO can help you gain a better understanding of an achievable timeline based on factors for cGMP manufacturing and beginning clinical trials.
53Biologics can help you in the production capacity for your preclinical batches or for the recurrent production of your recombinant protein
Range of Services
Once you decide to partner with a Biologics CDMO, it is important that you define whether or not every phase of drug development, testing, approval, and manufacture you want to do it with single CDMO or not.
Using an all-in-one CDMO has its advantages, such as improved communication and better timeline management with less risk for overlap when moving from one CDMO to another. But sometimes using a single CDMO for your new drug development and manufacturing isn’t possible due to a variety of constraints, such as capacity and availability during certain stages of development, and the flexibility needed to adapt quickly to meet Phase I timelines.
Also, you have to keep in mind that if you use more than one CDMO, you may be required to pay royalties to transfer from one CDMO to another, so be sure to include those costs into your total new drug development costs.
Review the stages of development and identify which stages will stay in house and which ones will be outsourced and to whom.
Don’t forget to evaluate the technology and science needed for your new drug development and determine whether or not your potential CDMO partner has experience in the formulation technologies you need.
Transparency regarding costs
Your selection of a Biologics CDMO based on its range of services and how much of your new drug development you have with one vendor may help keep your costs lower, but may not be possible due to time constraints. When you receive final cost calculations from potential CDMOs, be sure to ask if their final figures include estimated out-of-pocket expenses and capitalized costs.
Drug development processes may vary significantly due to findings in early-stage drug development and results from clinical trials. This makes drug development costs highly unpredictable. In this sense, the use of an experienced CDMO even is more crucial to keeping costs in check.
53Biologics has demonstrated to be cost competitive due to the lean and flexible operations structure.
Work a checklist of questions to ask to the potential Biologics CDMO partner, including whether or not you need to pay royalties when the project transitions from one CDMO partner to another, re-work due to molecule failures in early-stage testing, etc.
Speed and Quality of Development and Production
When you are launching a new drug with the goal of speed-to-market or being first-to-market, working with an experienced CDMO can be the difference between making it to market on time or not making it at all.
Be sure to ask about the potential CDMO partner’s availability and capacity, as well as their current experience and capabilities. Identify any changeovers or transfer of information, data, processes and new setup time if you are using more than one CDMO.
A CDMO who has experience working with a wide array of molecules and for various pharmaceutical companies can help identify potential issues as you develop processes or scale up, and can use design of experiments (DoE) techniques during process design to reduce risks as your new drug development progresses.
Experienced CDMOs also tend to have stronger scientific and technical teams who use their expertise to advance your drug to the next stage, as well as the technologies and facilities equipped to handle your specific drug development processes.
Choosing the Right CDMO is Vital to the Success of Your Project
53Biologics is a Biologics CDMO with extensive experience in decoding biologics overexpression providing services of cell line transformation, banking and characterization, analytical development, process development (USP & DSP) and batches production.
We work collaboratively with drug sponsors to provide innovative solutions to challenging drug delivery problems and to create advanced medicines.
53Biologics works in a quick, proactive and efficient way, always ensuring very high-quality standards. We have a strong R&D team for both strain engineering and bioprocess development and scale-up with a proven track record to support new product development.
53Biologics provides its partners with complete CDMO services. Contact us today to learn more.