Monday, February 28, 2022

What is a CDMO Pharmaceutical Company?

 

solid-dose-cdmo

Drug development is complicated, and when pharmaceutical businesses discover the correct CDMO, they not only fulfill deadlines or scale up fast to meet production demand but also save money and time.

When working with a full-service CDMO pharmaceutical company, a business can start with an idea and be guided through pre-formulation and formulation development, clinical trials, and commercial production.

What a Successful CDMO Partnership Looks Like

A partner is an organization aligned with your organization and wishes to assist you in reaching your objectives. When choosing a CDMO pharmaceutical company as a partner, search for one who has your best interests in mind, which is determined by the type of relationship you have with your CDMO partner. Is it strict with highly structured agreements, or is it adaptable to the drug development project at hand? Are they able to address your current demands while also assisting you in looking (and planning for) future needs?

Here are some things to think about and questions to ask yourself when looking for a CDMO partner for your pharmaceutical company:

1. Knowledge of, and expertise with, the technology and science required for your medication compounds

Are you in the early stages of developing a drug? Finding a CDMO with experience in several formulation methods can help enhance your drug development while the formulation for your compounds is being produced. Some complex formulation difficulties necessitate the use of nanotechnology.

2. Appropriately sized and equipped facilities

Are you looking for a solid dose CDMO company to help you develop complex injectables? To produce a successful, cost-effective conclusion, it is critical to match the equipment scale and material handling competence with the product batch size. Examine the facility to ensure it has the necessary equipment and monitoring for your drug development, such as laminar flow hoods, biosafety cabinets, isolators, and limited access barrier systems (RABs). Furthermore, the CDMO must adhere to the current reasonable manufacturing procedures (cGMP) required for regulatory compliance.

3. The ability to manage expenses and timeframes

Controlling costs during early-stage drug development and adhering to a realistic, if likely very aggressive, a timeline is dependent on the expertise of an experienced team that has worked with superior technologies and up-to-date facilities for other pharmaceutical companies. Make sure to request a complete costing view from your CDMO partner, including the cost differences between batch sizes and larger runs.

4. Field experience

Look for a CDMO with an experienced staff who can formulate the exact molecule. They will be able to examine the physical and chemical features of the substance, evaluate the drug and its intended target location, and recognize drug uptake. In addition, the CDMO team will need to understand particle size reduction, solid dispersion, and lipid-based techniques. These are all vital decisions to make when working with tiny molecules.

5. A Fit With Your Company

Finally, but most critically, consider whether the CDMO partner you consider hiring is a good fit for your company. Do they provide the necessary flexibility, collaboration, and innovation? Is it a good fit for their culture, leadership, and communication style? Do you feel safe entrusting your baby (drug development project) to them? Do they have the necessary experience for your project?

A good partner's onboarding and collaboration processes are other crucial factors. Transitioning your drug development to a CDMO that views you as another client can be difficult and time-consuming. Find one that offers first-rate communication, collaboration chances, frequent modifications, and access to critical project partners to help with knowledge transfer.

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