A contract development and manufacturing organization (CDMO) refers to a company that can provide solutions to pharmaceutical projects from drug development through to drug manufacturing. A CDMO can perform the various steps crucial to the development and manufacturing of the pharmaceutical product. This allows the client to focus their efforts on other aspects such drug discovery and marketing.
By utilizing a contract manufacturer to develop, formulate and manufacture their pharmaceutical product, the client company can focus on drug discovery and marketing without increasing its overhead costs. The purchasing and maintenance of infrastructures and equipments, along with the hiring and training technical staff, can be costly. By contracting an CDMO, all these resources can be allocated to other important aspects of the project or to another project in the pipeline. Partnering with a CDMO is especially logical for smaller pharmaceutical companies with limited budget and capital for drug development.
Selecting The Right CDMO
To select the right and competent CDMO, the areas that needs to be assessed and evaluated are capabilities, experience, processes, personnel, equipment, regulation insight, capacity, location and financial stability. Being satisfactory in each of these areas all contribute to the success of the project. Falling short in any of these areas will lead to hindrance and delays, and ultimately failure.
Selecting the right CDMO is difficult and involves careful evaluation of the client’s needs and the CDMO’s capabilities. The potential partnership is complex and can determine the success or failure of the company, especially for small or startup companies with limited resources and budget. However, partnering with a CDMO is a great option for companies that lack the knowledge, expertise and resources to bring the compound or molecule from discovery to market. Even for more established companies, partnering with a CDMO allows the company to focus their energy and effort on other projects.
A properly selected and competent CDMO can be vital. A CDMO with development expertise can help the client company initiate and manage the processes, in addition to facilitating the decisions during the early stages of drug development. Additionally, a CDMO with experience in manufacturing can help reduce costs significantly. With all the benefits in partnering with a CDMO, how does a company select the right CDMO for their project? The search for the right CDMO will be challenging and time intensive. Here are some key areas to evaluate when finding a CDMO.
One of the first thing to consider if whether to partner with one company or several companies. Some CMO or CDMO specialize in specific area of drug development. This includes formulation development, stability studies, process development, early to late clinical material, scale-up, product registration and commercial production. Partnering with companies that specialize in these areas may have have it benefits; however, partnering with one full service CDMO help save money and allow resources to be budgeted to research and development or marketing.
How to select the right CDMO? The basic questions to ask are:
How long as the CDMO been in business and what kind of projects have it completed in the past? Does it have experience with complex or cytotoxic compounds?
Does it have the capabilities, personnel and equipment to work on your compound?
Does its history align with your current project or future project?
Does it have experience with working alongside its regulatory authority or the regulatory authority of your intended market? Although it might be familiar with its domestic regulations, how extensive is its knowledge with international regulations?
Assess The Vitals
Another important area to assess is their experience. The pharmaceutical industry is diverse and there are many different types of projects. Depending on your project, ask the CDMO if they have the relevant experience. For example, if the project includes lyophilization, ask the CDMO if they have successfully completed a lyophilization project in the past and how deep is their experience. If relevant, assess their familiarity with controlled substances, hormones, cytotoxics, nanotechnologies, microspheres, biologics, injectables and filling.
One of the most important question to ask is what the contract manufacturer is capable of accomplishing and if they can deliver the services required for your project. Assess the CMDO’s experience with technology transfer, drug development, drug formulation and drug manufacturing. Also consider what the CDMO will do themselves and what will be outsourced by them.
Each company will have their own method in assessing and proceeding with the project. Take into consideration the CDMO’s process before selecting. Does it match your company’s business operation and do the timelines synchronize with each other? Does the CDMO’s processes allow for periodic reviews to assess performance and quality. Are there opportunities to make changes to the project in terms of schedule, budget and direction? These are important consider since projects are complex and difficult to manage. Changes and periodic reviews are necessary to ensure the project is heading toward success.
The employees at the company are huge contributors to the success of the project. The competency of the people representing the CDMO, such as the project manager, drug development lead, and drug manufacturer lead, are obviously important. However, do not forget about the employees handling the equipment and manufacturing the product. Focus on their level of training with the equipments and familiarity with procedures.
The equipment is just as important as the personnel operating them. Besides making sure the technologies are up to date and current, it is equally essential to make sure that periodic maintenance and calibration are performed so the equipment functions properly. With certain projects, new equipment may need to be purchased so be clear as to which party will be paying and how long the installation and operator training will take.
Every project will involve some kind of regulatory compliance, whether it be related drug development, drug manufacturing or drug distribution. Inquire about CDMO’s regulatory compliance and if they meet certain regulations relevant to your project. Regulatory requirements for health, safety, environment and consumer for will differ between countries. Make sure it is compatible with your country and aligns with your company’s project. If the product need to be registered, make clear who is responsible for accomplishing that with the regulatory authority.
Another important aspect to consider is if the CDMO has the capacity and ability to handle your project. Will your project be the largest or the smallest project the CDMO has ever handled? If the CDMO fall in either extreme of the spectrum, it is concern. If it is the largest project they ever handle, do they have the capacity to handle it? If it’s their smallest project, will they prioritize the project? Does the CDMO have enough space to house the equipment, assembly line and storage of raw and finished material? How large is company? Will the employees be spread thin across multiple projects with your project being one of them?
Where is the work completed? Some CDMO will have the project completed at multiple sites for different components of the project. Make sure to determine where the development, manufacturing and testing are taking place. The domestic and international policies may impact the shipping and other logistic costs of your project. Make sure to factor in the difference in languages and laws between countries.
One of the most important consideration is the CDMO’s financial stability and their ability to handle problems. Does the CDMO have a plan in case of raw material shortage, natural disaster or equipment failures? Do they have a effective plan to manage inventory and will they meet your expectations? Would the selected CDMO close their business after starting your project? Determining the financial stability of the CDMO and its supplier is one of the most important assessment to conduct when selecting an CDMO for your project.
As a competent CDMO, Burrard Pharmaceuticals is capable of assisting with formulation development, process optimization, stability studies, scale-up, product registration, regulatory support, production, fill-finish services and packaging. By providing all these services, we strive to assist our clients in streamlining their project and reducing costs.