With everything involved in bringing a drug to market, enlisting the services of an experienced CMO can prove to be a very worthy investment. Ideally, the relationship between a pharma company and its CMO only becomes smoother, more efficient, and more rewarding over time – as your CMO becomes increasingly familiar with your products and unique needs.
In the pharmaceutical industry, raw materials and intermediates are produced and then converted to the respective molecules according to precise processes. The most common challenges are the drug manufacturer may not have suitable facilities available or technology sufficiently advanced to produce the product at the most competitive price.
For pharma companies, centralizing all the processes and documentation, as well as preventing and resolving Environment, Health, and Safety (EHS) issues, can become cumbersome and introduce more risk. (See our earlier post on EHS issues here).
What it Means to be a CMO
Because of these issues, over the past four to five decades, the concept of Contract Manufacturers has steadily taken hold in the pharmaceutical world. Contract manufacturers possessing adequate capacity, appropriately skilled manpower, and expertise in process chemistry have led to the evolution of contract manufacturing organizations, or CMOs.
Contract manufacturing firms have added to overall facility capacity, answered technology needs and provided staff expertise. They have also become skilled at centralizing documentation and preventing EHS issues – thereby reducing the risks involved in drug production. While the growth of this industry was initially slow, the late 90s saw it accelerate and expand broadly. First popularized in Europe, CMOs are now found in India, China, and Southeast Asia as well as the U.S.
How a CMO Supports its Customers
The success of a CMO rests on building a reliable, trusting partnership between the contract firm and the pharma or biopharma customer. Both parties in this relationship take a long-term view. Success means maintaining a healthy, transparent, mutually beneficial relationship over the years while working together to carry out operations. The keys to this relationship are proper communication, transparent financial dealings, sound business ethics, as well as mutual recognition and support when needed.
First Things First: Understanding a Customer’s Requirements
The pharma company needs its product to be delivered on time, on budget, and with expected quality levels. Both cGMP and EHS guidelines must be strictly followed to ensure quality and safeguard the customer’s reputation in the eyes of the consumer. The CMO’s financial strength and ability to deliver in an ever-evolving market will help secure its status as the customer’s preferred provider.
As in all relationships, communication (including technical writing skills) is vital to strengthening the ties between a customer and CMO. Transparency allows the customer to have full knowledge of everything concerning their product and its manufacture.
For every stage of the process, we believe a feedback mechanism should be used to encourage an open dialogue between the customer and the CMO, making sure no stone is left unturned. Accuracy keeps processes running smoothly, and prompt responses to customer queries reaffirm the customer’s place at the center of the operations, keeping them well-informed and allowing the CMO to respond to any needs that arise as quickly and efficiently as possible.
Building Trust by Not Competing
A CMO that puts its customers first also refrains from competing with their clients by not producing generic versions of customer drugs. Neuland is among these CMOs, operating as purely an API supplier. We’ve found that working exclusively to help our pharma clients develop and bring their drugs to market – while not competing generically on the side or in the future – invests us in our clients’ success.
Meeting Timelines & Quality Expectations
Another aspect of CMOs that reinforces the customer relationship is the ability to stay on track and meet timelines. Customers expect their CMO to regularly update them on the activities being conducted, in a transparent manner. In addition, the progress needs to be documented, recorded, and shared efficiently.
The goal is to ensure that the timeline, project cost, manpower and capacity used, quality assessment, environmental impact and personal safety are always considered while executing the project on time and producing the quality desired. In addition to everything that goes into manufacturing the product, managing timelines, costs and resource allocation are also crucial at every stage of execution.
Collecting Customer Feedback
After all the work has been performed, the deadlines met and the product delivered, the CMO’s most critical task remains: collecting feedback about their service. A CMO’s success relies on customer satisfaction, and as such, it should be measured regularly.
For best results, we know the right tools must be used—including regular business review meetings and online platforms to share issues, challenges and problem resolutions, and interaction with cross-functional teams (ours is called GuarD). Only after analyzing all the feedback can a CMO take corrective actions and address any issues raised. Taking the time to carry out this step demonstrates a CMO’s commitment to their customer, and that they value their business in both the short-and long-term.
What has your experience been with CMOs? What is the biggest challenge you’ve had?