By Kevin Debbs and Christa Myers, CRB
The age-old debate of whether to outsource production to a contract manufacturing organization (CMO) remains for mature, emerging and virtual biopharmaceutical companies.
The core of the issue is brand protection. While outsourcing can minimize capital and labor costs, the challenge lies in the process of evaluating and selecting the right CMO as your manufacturing partner. How can you minimize potential consequences, including damage to your brand and loss of market share and revenue? How can you minimize the risks to product quality, while ensuring that equipment, processes and procedures used in manufacturing will maintain the intended strength, integrity, safety, purity and quality of the drug or product? And how can you do it all within budget?
While the answers to these questions will be specific to each company and its products and processes, below are some key drivers to help you make the right decision if you do turn to a CMO. Keep in mind, these drivers need to be in line with your business goals and ultimately take your product to market in a safe, compliant and cost-effective manner.
Scale/Volume/Capacity—A CMO that already has a number of clients may have a small window in which to produce your drug. Consider some of the following questions:
History of Observations by Regulatory Agencies—Manufacturing facilities are built to protect the operator, the product and the patients, so quality systems and facility and equipment design are critical. When considering a CMO, do your homework. Research its history with regulatory agencies, its documentation practices and its process and testing procedures, including responsiveness to problems and corrective and preventative actions previously documented. Are their operators well trained? Do they understand the Current Good Manufacturing Practices and the nature of why your procedures are written the way they are? Search the Food and Drug Administration’s website for a CMO’s previous inspection observation summaries. Some questions to ask include when was the last inspection, what were the findings, what were the responses to remediate the observations? Were the responses accepted, and were the corrective actions completed and verified?
Personal Interviews—You can’t just rely on industry reputation and past experience; you must conduct personal interviews with the CMO’s executives, management and current staff on site before you sign a contract. You will need to interview previous and existing customers and rely on vendor feedback. When touring the facility, ask about the existing equipment and its history:
Technology/Equipment Capacity and Capability—Each product will have its own unique set of critical quality attributes and process parameters that will need to be considered to determine whether the CMO has the correct fit of technology and expertise:
Operator Exposure Limit Understanding and Containment Strategy—Because CMOs may run two days of product for one client and then two days for another, cross-contamination prevention will be key. If there are any highly hazardous compounds that are produced in the facility, how is it controlled and contained? What are the cleaning procedures between products? While each facility should have its own thought-out containment strategy, companies may still want to have a dedicated set of equipment format and product contact parts exclusively used for their runs. Drug products created for specific high-risk populations may have additional containment requirements as well. Ensure the CMO can accommodate them.
Equipment Reliability and Lifecycle—Manufacturing equipment is advancing very rapidly—especially in the area of microelectronic sensors, vision systems and analytical instrumentation—so fast, in fact, that equipment more than five years old is likely to be obsolete to achieve all your requirements. Equipment even older than that may not have the sensors or instrumentation to detect many of your critical defects in line. This translates into lost product and lost revenue. When touring the facility, ask how old the existing equipment is and ask to see it run. Inquire about the equipment manufacturer and any problems with it. Maybe the equipment has been in the storage room for four years, but when examined, it is actually 20 years old. If so, how will the CMO replace a spare part if needed? Are the controllers on the machine even available for purchase, or is the CMO shopping online bidding sites to find replacement parts?
Overall, the evaluation of a potential CMO should be driven by the specific parameters of your unique process and business goals. Partnering with a third-party process specialist like CRB with the necessary industry knowledge and experience will be critical to identifying potential risk and cultivating a relationship with the right CMO.