How to Select a CDMO for your company?

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Contract development and manufacturing organization are Pharmaceutical facilities that contain all the requirements for manufacturing a pharmaceutical product but are not allowed to manufacture any product under their brand name. Under their guidelines and quality checks, they use these resources to produce or manufacture for other pharma organizations.

Contract development and manufacturing organization have been joint in the pharmaceutical industry for years. They are helpful by offering manufacturing-related services to pharma organizations that cannot perform manufacture on their own, - thereby sharing the burden of Pharma product manufacturing by managing different functions at their facility. Additionally, they are responsible and accountable for abiding by all the regulatory requirements, in addition to the pharma organization's requirements for which it manufactures pharma products.

Functions of contract development organization

Let's discuss some common function of a CDMO, and see how they contribute to a pharmaceutical industry.

Formulation

The formulation is the research and development for discovering new products. It consists of a range of functions critical to the formulation process.

Some function that CDMO performs as a part of the formulation includes the following.

Stability studies: Stability studies determines the product characteristics throughout different stages of the product life cycle, such as shelf life, product's behaviour to changing working, operating and environmental condition. The main aim of feasibility studies is to test the resilience and functionality of chemical properties and determine whether the product's therapeutic effects will be practical.

Process identification refers to identifying production, storage and testing procedures relevant during drug manufacturing. Because different pharma products require different manufacturing processes that are identified, developed and tested at this stage for their validity.

Method development is an integral function of a CDMO and refers to creating experimental conditions for analytic procedures on a pharma product. Its primary purpose is to identify and quantify the chemical composition of a pharma product. The CDMO begins method development by analyzing the requirements of a client. It then develops methods that are acceptable to the client .

Clinical studies. Clinical studies are an integral part of drug discovery and development. It involves the trial of a new drug on humans with a disease to check its efficacy, bioavailability, success ratio and any side effects. Regulatory bodies do not allow organizations to develop products without demonstrating suitable clinical studies. 

The CDMO can perform clinical studies for phase 1 and the last stage of program development. In clinical studies, CDMO can help the organization in areas such as patient identification, trial sites, selecting the desired demographic, suitable dosing strategy and product identification.

Registration. CDMO can help register new drug products for a Pharma organization. It can also help pharma manufacturers in the drug renewal process. 

The registration process is the final stage before commercial manufacturing and is essential in drug development. If not performed timely and carefully, it can halt the entire development of a drug.

CDMO helps a pharma organization register by providing all the documented proofs related to production processes. It can document that a pharma product is manufactured in accordance with all the facilities, requirements, development, and personal expertise as set by the regulatory body. It also demonstrates that the product is safe for human consumption and can provide the desired therapeutic effects. 

Commercial manufacturing. CDMO also performs commercial manufacturing of the Pharma product. For this purpose, CDMO contains all the requirements for commercial manufacturing, such as facility, production equipment, quality control and assurance.

Advantages of CDMO

Let's discuss some advantages of CDMO, and see how pharma product manufacturers leverage the expertise of a CDMO for their Pharma products.

Personal and resource expertise

Contract development and manufacturing organizations are manufacturing industries that routinely develop products in the pharma domain. They are involved in drug development and manufacturing for every type of pharma organization - from small-scale to large-scale and from pilot to commercial manufacturing.

For this purpose, they continuously invest in themselves in different areas to remain ahead by adopting the latest technology, implementing advanced manufacturing practices, and adopting updated quality policies and regulatory requirements. They also concentrate on improving their workforce's knowledge, skill and expertise to deliver the right products for their clients.

All the factors mentioned above give fare advantage to CDMO over other pharma manufacturing organizations because they have less product diversification and a relatively static market footprint.

Scalability

For a CDMO, it is easy to scale up a pharma product from any batch number, or from pilot scale to commercial scale.

Scalability is often accompanied by risk in terms of time, money and resources.  A CDMO can easily work by tackling the risks associated with scalability.

The main reason being the experience in handling these types of risk. They also contain necessary skills and tools, to overcome them. CDMO also possesses all expertise such as equipment, laboratory testing and facilities to successfully involve the Pharma products scalability. 

CDMO can be particular helpful in cases when a risk of product variation is present, commonly, when shifting a small batch to large scale. This is often due to poor formulation, inefficient testing and failure to apply quality principles.

Cost effective

Contact development and manufacturing organizations have the advantage of providing drug development and manufacturing services at reduced cost. This becomes effective for Research and development, which is the most time and cost consuming part. 

Costs associated with other processes such as manufacturing, testing and registration are also reduced as compared to when a pharma client performs these activities at their own site.

Reliable logistic provider

CDMO can also provide logistic functions and support to their Pharma clients. CDMO that provides logistics support, keep dedicated resources and facilities to supply the products of their pharma clients. It enable CDMO's to provide logistics support in difficult geographical locations, where their pharma clients cannot provide it or becomes costly for then to operate.

CDMO can also provide specialized logistic features such as temperature controlled containers, fleet tracking and secure delivery of Pharma products, in case of critical drug products such as vaccines, antibiotics and HI potent active Pharmaceutical ingredient (HPAPI).

Selecting a CDMO for your company

Following are some factors that can be helpful in selecting and shortlisting a CDMO for your Pharma manufacturing requirements.

Identify your needs

The first and foremost factor is to know what your needs are and what problem you want to solve.  Why you want to go for a CDMO?

 Consider answer to question such as

1. What service your organization requires? Because, CDMO can offer range of services to their pharma clients, which does not necessarily mean that you go for them. Only shortlist your requirements and then opt for CDMO service. For example, either you require drug development, method development,  commercial manufacturing, or you want all of these functions

2. Do you have enough experience, knowledge and skill to effectively deal with a CDMO for your requirements. Because, you have to justify their actions, methods, process and manufacturing approach to regulatory body during their inspections.

3. Is your company a first time startup in pharmaceutical business or an experience one. If you are a first time start-up, consider beginning with a low volume to gain experience in dealing with CDMOs.

4. Do you have enough finances to cover the cost of a CDMO?  Because, pharma industry is highly dynamic, and cost estimates can anytime go wrong. So prepare enough sources well advanced of selecting and finalizing the CDMO

All the above questions are helpful in determining a clear path for shortlisting the right CDMO which will help you in successfully achieving your goals.

What are there are quality standards

Although, pharma client is responsible for ensuring quality in their products, the CDMO is also responsible for quality in final products, by implementing it in all stages of the product life cycle.

Quality becomes critical because world’s competitive markets such as China and the US are focusing more on quality, rather than quantity.  The regulatory bodies of these markets can order a pharma manufacture to recall their products, or even shut down plant operation, if serious  loop holes are found in quality principles.

Some factor that can be considered when deciding quality attribute of a CDMO includes the following 

• What is the production capacity of a CDMO? -  A high volume CDMO has often best quality principles in place 

• What is the experience level? -  Like above CDMO having vast experience will also have good quality principles, in place

• What is the reputation of a CDMO? Any bad reputation such as regulatory strikes, plant shutdown, and non-accreditation to standard bodies is not a sign of good quality CDMO.

Does your CDMO has the capacity to fulfill your requirements

By function, a CDMO can fall in various categories such as drugs type, capacity, and function. Among these CDMOs, some can be only expert in commercial manufacturing while others can only perform packaging operations, while other CDMO’s are capable to provide all functions related to drug manufacturing. 

Shortlisting a CDMO on the basis of what services they provide is the most critical. Because every Pharma client has its own specialized needs which cannot be served by every CDMO. It also helps in reducing un- necessary cost expenditures, which automatically reflects in the final finished product.

About the Author

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.