Health and Fitness

CDMO: What is it & Why Do You Need One?

Due to the nature of drug substances becoming more and more complex, many pharmaceutical contract manufacturing companies are encountering challenges in designing and creating drug substances.

There’s a requirement for fast innovation and production to bring the solutions to various markets quickly and at a good cost.

This approach is always on the top of mind for most pharmaceutical contract manufacturing companies.

Partnering up with a contract development and manufacturing organization (CDMO) or contract manufacturing organization (CMO) can help pharmaceutical companies in many ways.

The most important way would be of launching new products or formulas in the market without worrying about financing additional infrastructure to support them.

Why do pharmaceutical companies require CDMOs?

Developing a drug is a complicated process. When pharmaceutical contract manufacturing companies enter into a cooperation with the right contract development and manufacturing organization (CDMO).

It allows them to meet deadlines, production demand and saves cost and time at the same time.

Pharmaceutical manufacturing companies can reduce infrastructure costs by simply avoiding the requirement of investing in additional production and manufacturing space.

They can also cut costs associated with buying specialized equipment since the contract development and manufacturing organization (CDMO) has access to equipment and facilities.

These companies can also acquire additional expertise such as research and development carried out by researchers with specialized skills.

This will allow them to meet the requirement of the drug development project and lower their payroll costs.

They can also meet production deadlines and stay updated with the demand-supply ratio.

Production volume, adding drug variation, growing production without increasing expenses of labor, facility space, and many other factors will contribute to making it happen.

Read More: 6 Reasons for Pursuing a Pharmaceutical Career?

5 Things to consider when choosing a CDMO partner

Let’s look at the five things pharmaceutical contract manufacturing companies should evaluate before choosing a contract development and manufacturing organization (CDMO).

  1. Access to experience in technology & science for drug molecules

In the early stages of drug development, the formulation is designed for your molecules.

It is crucial to discover a CDMO that has experience in a variety of formulations technologies that can help in drug development.

Few formulation challenges need nanotechnology, and Ascendia created three patented nanotechnologies to assist biopharmaceutical properties.

  1. Right-sized and properly equipped facilities

Making sure that equipment and material handling expertise are on par with the production batch size is critical to ensure a thriving, cost-effective outcome.

Assess the facility and decide whether it has the right equipment necessary for your drug development.

Also, CDMO must work under current good manufacturing practices (cGMP), which is vital for compliance with regulatory guidelines.

  1. Keeping the costs and timelines in check

Keeping the costs and timelines in check during the early stages of drug development is a requirement when selecting the right CDMO.

But this is possible only by a team that has knowledge and experience in working on various advanced technologies and facilities and has already done it for different pharmaceutical contract manufacturing companies.

Don’t forget to request your CDMO partner for an entire view of cost, including the cost differences between batch sizes and larger runs.

  1. Field Experience

Try to find a CDMO with a skilled and experienced team that can develop the specific molecule.

They will not only be able to evaluate the compound’s physical and chemical properties but also decide the drug, its uptake, and its intended target site.

The CDMO team should also know key factors of small molecules such as particle size decrease, solid diffusion, and lipid-based approaches.

  1. Perfect fit for your company

This is the last but the most important point. You need to determine whether the CDMO partner you are hiring fits with your organization or not.

A few questions that you should ask yourself before entering into a partnership with CDMO include:

  • Do they offer the flexibility, cooperation, and innovation you need?
  • Is their culture, administration, and communication style a good fit?
  • Do you feel satisfied handing your drug development project to them?
  • Do they even have the knowledge, understanding, and experience your project needs?

What is a contract research organization (CRO)?

CRO is hired by pharmaceutical, biotechnology, and medical device manufacturers to conduct clinical trials after the drug is developed by the CDMO.

CROs have to plan, coordinate, execute, and supervise all of the processes involved in the development of clinical trials.

These processes include choosing a site, recruiting participants, managing the trials, data, and more.

CRO also handles feedback and requirement from multiple process members such as manufacturers, trial sponsors, ethical councils, foundations, researchers, legal branches, trial participants, and regulatory agencies.

Some CDMOs also offer research services themselves or can refer their pharmaceutical company partners to a trusted CRO as needed.

What is the difference between CMO and CDMO?

A contract manufacturing organization (CMO) is contracted by pharmaceutical contract manufacturing companies to develop drug substances.

The development process consists of solution, emulsion, nano-suspension, liquid-filled capsules, aseptic filling, terminal sterilization, pre-filled syringe and vials, and tablet and capsules.

Many pharmaceutical companies outsource their drug manufacturing rather than producing them in-house because it is cost-effective.

Contract development and manufacturing organization (CDMO) takes care of the manufacturing of the drug substances.

It is also responsible and involved in all of the invention and development work that occurs before manufacturing one.

The whole process consists of various stages such as development, production, and analysis.

Also, even the French pharmaceutical companies no longer need to build and staff dedicated innovation and manufacturing facilities.

Formulation, analytical services, blending, coating, converting, packaging, serialization, and shipment are offered by contract development and manufacturing organization (CDMO).

These CDMOs can begin with a concept or a ready-to-go formula, with pre-formulation and formulation development services available, as well as clinical trials and commercial production.

With the discovery of the right contract development and manufacturing organization (CDMO), pharmaceutical companies can gain flexibility, cooperation, and innovation services to assist in speeding up to market and reduce the costs.

Drug substances are becoming more and more complex and prompt innovation and production are needed.

CDMOs can speed up the drug development process and improve pharmaceutical contract manufacturing companies’ bottom lines.

What does an effective CDMO partnership look like?

A partner is someone who will be aligned with your company/organization and assist you in achieving your goals.

When deciding on a CDMO partner, you should prioritize those that have your best interest in their mind.

Another thing that is also important is the nature of the relationship. You should ask yourself the following questions before entering into a partnership with any CDMO:

  • Do you have an inflexible relationship consisting of structured agreements, or it is flexible to fit the ongoing drug development project?
  • Are they able to satisfy your current requirement and help you at the same time for planning for the future?

Onboarding and collaboration practices are also a parameter to differentiate between a good or bad partner for your company.

It is often difficult to transfer your drug development knowledge to a CDMO who considers you just another client.

It is advised to discover a contract development and manufacturing organization (CDMO) that comes with top-class communication, opportunities for collaboration and periodic adjustments, and entry to key project partners to help make the knowledge transfer smoother.

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