Managing a method transfer: How to achieve a smooth transition to...

Managing a method transfer: How to achieve a smooth transition to manufacturing

By Cory Nelson, Assoc Director of Contract Manufacturing and Continuous Improvement, WuXiAppTec

Method transfers are integral to getting a product to the manufacturing floor. The transition of information and processes from an original equipment manufacturer (OEM) to a contract manufacturing organization (CMO) may seem mundane, but a smooth method transfer requires a significant amount of detailed work and collaboration.

Success in taking a product from prototype to manufacturing and ultimately to market will depend on thoughtful planning, partnership, and attention to detail. Knowing what a manufacturing partner will need from you, what pitfalls to watch for and how to vet CMOs will help you with the transfer.

What a CMO will need from you

CMOs gauge your readiness for a product launch based on how well your product and process are defined and how knowledgeable you are about launching a product to the market. Your depth of knowledge and preparedness for this information exchange can save you significant time and money. Here are a few categories of questions to consider:

Regulatory approval

Gauging regulatory pathways and the approval process helps understand your testing and validation needs, the product and process manufacturing requirements, and which markets and regulatory bodies are in play.

Product information

CMOs will ask for every detail available about your product including predicate products, performance requirements, packaging, labeling, release testing, shipping, and any unique raw materials, such as biologics and tissues.

Process progress

Similar to product information, CMOs will need any details about your production process. They will ask for an overview of any special equipment needs, target lot size, sterilization, material procurement and management, intermediate products, finished product shelf life considerations, and special storage conditions.

"A highly knowledgeable CMO understands the regulatory landscape and validation process to help educate and support you through manufacturing and approvals"

When responding to information requests from CMOs, you may not have all of the answers. While you should aim to provide as much insight as you can, most CMOs have access to a variety of experts who will aid in determining your final product and process requirements. What a CMO’s experts cannot do is help prevent the development pitfalls that happen before you come to them.

Avoid pitfalls

Pinpointing inefficiencies during prototyping is often tricky. Be aware of the following pitfalls early to help prevent unnecessary challenges and delays:

1. Believing product design is frozen. CMOs can provide critical feedback that can drive the process or even product design changes for several reasons, including regulatory considerations, functionality, and production. It is essential to approach these conversations with an open mind.

2. Trying to please everyone. While product feedback is vital, especially during clinical trials, your initial design likely won’t fit the needs of every customer. Making changes to product or process post clinical builds will delay your launch and add cost. Choose appropriate tradeoffs.

3. Testing too soon. If you make changes or do too much validation on the front-end, it will likely lead to additional justification of those changes and retesting.

4. Setting the qualification bar too high. Trying to accomplish a level of performance beyond what is necessary can waste vital time and resources. It could even lead to a failed market launch if early tests had passed with more reasonable – and still acceptable – requirements.

How to vet a CMO

It can be challenging to know precisely what is needed from a CMO before working with them, but discussing the following topics will help determine if they will be the right partner. Some critical issues related to purchasing power, partner relations, in-house capabilities, and regulatory expertise.

A CMO with reliable purchasing power can negotiate fair prices and consistent supplies. If a CMO uses a disproportionately high amount of single or sole-source suppliers, they may not have the needed leverage to maintain a high-quality, regular supply chain at a reasonable cost.

Partnerships are a vital part of CMO’s service offerings. Inquire about previous projects to understand their responsiveness. Asking about relations with their shipping and sterilization partners can help to understand existing agreements.

Considering a full-service CMO, with testing, licenses, certificates, and risk assessment services, can minimize inconsistencies, errors, and “finger pointing.” If the in-house capabilities of a CMO are not expansive, at a minimum, ensure they have strong partnerships, so they can assist you in filling any of your program gaps. As you ask questions about their capacity, you will want to know if they outsource boosts to subcontractors or if they manage those internally.

A highly knowledgeable CMO understands the regulatory landscape and validation process to help educate and support you through manufacturing and approvals. They also should clearly define the scope of the project and delineate responsibility for critical steps.

You can avoid method transfer traps and headaches with careful planning and partnership. Being collaborative and asking the right questions will go a long way toward a successful manufacturing experience with a CMO and ultimately, a high product launch.

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