By Barbara Berglund, COO, CMC Turnkey Solutions
You just received an official notification from your CMO: It is going to remediate the facility in which you have been making a commercial product for six years. All production in the facility will cease in 20 months; an all-new facility has been built nearby and is ready for product transfer starting in three months. The CMO will provide the project management for the technical transfer.
Now, you look at your options. You can stay with your current CMO, or you can take this opportunity — forced though it may be — to determine if it is time for a change. Perhaps you have products at another CMO, or perhaps you have previously done business with another CMO. Perhaps you have been discussing changing for several years and have been looking for a different kind of strategic partnership than what is currently being offered to you. You would seek recommendations from colleagues and look for high-level track records and technical capabilities as you begin thinking about options. Changing how you look at the current CMO relationship may weigh heavily in your decision.
It is always easier to stay with the current CMO, even if there is a site transfer in the immediate future. So, first, examine your satisfaction level with the current CMO. There is much to consider in the relationship: There is the business relationship, the technical troubleshooting relationship, the project/program management relationship, and the relationship with the quality and regulatory philosophy. Look at the number of released (and rejected) batches and the yield. Essentially, are you getting what you are paying for? Examine the investigations over the last six years. Are they thorough, are there repeat issues, does it appear there are control issues? Look for issues in the field with your own product and the regulatory track record for other products manufactured at the CMO. Is there conflict when your team and the CMO team discuss quality and regulatory strategies? Is it difficult to gather knowledge and information? Is the project team functional? Is the CMO responsive to your needs and requests?
Next, consider the complexity of your own process. How difficult was the development and transition to the current CMO? There may be a considerable expense if you change. Does your process require technology that is not common, and do you own all the equipment such that you can ship it to a new CMO? If a deal has been struck with the current CMO, it’s possible that you purchased specialized equipment that is now jointly owned or even wholly owned by the CMO. Whether there is unique processing or not, examine whether another CMO has the capabilities you need. There are also opportunities here; if new technology has been developed, or if the equipment you own has been improved over the years, this may be an opportunity for wholesale change, whether you make a move or not.
As you consider the possibility of change, consider the potential for expanded or new partnerships. Perhaps your current CMO offers all the partnership you are looking for, but perhaps you have other products or a pipeline of clinical trial products. Perhaps you are looking for a CMO that also has API manufacturing capabilities, the ability to make both oral and parenteral products, or one that manufactures medical devices. Maybe you are looking for a facility with a strong R&D team to develop processing for new products. Possibly you would like to offer your own R&D to a partner that wants a generic pipeline but does not have the staff to develop test procedures and formulation development. Perhaps a CMO with both commercial and clinical packaging or a strong marketing team is appealing. Having the capabilities for ICH stability studies may be a benefit as well.
To make a sound decision, make use of a checklist/risk assessment. For example, list the items that are the most important to you in making the best choice. It may be that, with multiple products, multiple checklists will be needed. This might mean listing, in rank order weighted by importance to you, parameters such as personal experience with the CMO, technical capabilities, regulatory history, project management philosophy, quality systems, flexibility, capacity, timelines, regulatory commitments, laboratory capabilities, and other considerations. Then, beginning with your current CMO and then adding others, score each CMO on how well they comply with each category. Multiply the weight by the score, and see how your current CMO stacks up to other CMOs. For example, for a product that is not technically complex and is relatively inexpensive to manufacture, the most important thing might be capacity. In this case, you may weight this as a 10, and then look for a CMO with the highest rating in capacity to inform your decision.
For final decision making, there will be on-site visits, technical telecons, and due diligence audits. Several CMOs may pass an audit, and if you add in the risk assessment, this helps to quantitate a good decision. There is still opinion involved in the weighting and the rating, but to be able to put a number on each CMO allows for clear communication to management about why sticking with the present relationship or moving to a new CMO is the best decision for the good of the product or for the organization.
In the end, the question to be answered is: Is my CMO taking care of my needs, or is it time for a change?
About The Author:
Barbara Berglund is COO of CMC Turnkey Solutions, where she applies over 20 years of experience in finished pharmaceutical, API, and medical device manufacturing. In particular, she has direct experience with quality assurance and manufacturing of commercial and clinical trial sterile liquid and lyophilized parenterals, microencapsulated products, intravitreal products, suspensions, and solid dosage forms. She has held strategic leadership positions in quality assurance, quality control, sterile manufacturing, and project management, and has a particular interest in technical transfers both of processes and analytical procedures.
Barb has supported development of scientifically sound regulatory strategies to assure compliance and to manage knowledge obtained from pharmaceutical development through clinical trials and into trouble shooting commercial manufacturing. She has led QA teams responsible for oversight of development and transfer of processes and test procedures for both novel and generic drug products. She has created and implemented programs for test procedure technical transfer based on ICH guidelines and has led teams to implement ISO 17025 in multiple laboratories. She has managed programs for ISO 9001 and 13485 certification and for gap analysis and compliance with updated regulations.
Barb has an undergraduate degree in chemistry and postgraduate degrees in chemistry and pharmacological and physiological science. She received her PMI PMP (Project Management Institute Project Management Professional) certification in 2007, and her ASQ CQA (American Society for Quality Certified Quality Auditor) and ASQ CMQ/OE (Certified Manager of Quality and Operational Excellence) certifications in 2015; she has maintained all certifications.