Emerging and virtual biopharmaceutical company’s ask themselves whether to outsource production to a contract manufacturing organization (CMO) or purchase equipment for in-house manufacturing?
At 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 pharmaceutical 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 pharmaceutical CMO. Keep in mind, these drivers need to be in line with your business goals and ultimately get your product to market in a safe, compliant and cost effective manner.
Scale/Volume/Capacity – A pharmaceutical CMO that already has a number of clients may have a small window in which to produce your drug. Questions to ask include: Does the batch size and length of filling time required to produce your drug on their machines increase your risk? Does the speed of their machines match your batch size in volume, timing and capacity? Will your batch size and number of lots be a small fish in a large pond or possibly overwhelm their production schedule? If there’s an upset in manufacturing, will your manufacturing date get postponed? If you are manufacturing for a specific time period or seasonal distribution, and you miss the date, you could loose your market share. Technical competence, available machinery and resources must be accounted for. Consider some of the following items: Is the equipment built to reduce rejects? Does the equipment have the dose accuracy or volume control to meet your user requirements? Can the bulk of the batch be preserved if a machine failure occurs? Can the pharmaceutical CMO staff provide feedback of developmental or troubleshooting work they have successfully executed?
History of Observations by Regulatory Agencies – Because manufacturing facilities are built to protect the operator, product and the patients, quality systems and facility and equipment design are critical. When considering a CMO, do your homework. Research their history with regulatory agencies, their documentation practices, their process and testing procedures, including responsiveness to problems and correction and preventative actions (CAPAs) previously documented. Are their operators trained well? Do they understand the current good manufacturing practices (cGMP) and the nature of why your procedures are written the way they are? Search the FDA’s website for a CMO’s previous inspection observation summaries (http://www.fda.gov/ICECI/Inspections/ucm250720.htm). Some questions to ask include: When was the last inspection? What were the findings? What were the responses to remediate these observations? Were the responses accepted and 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 CMO executives, management and current staff on-site before signing 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: How old is the equipment? What products were produced on the equipment? What is their reject rate for a given batch size? Will any new equipment need to be purchased for your runs? Will that be included in the quoted price? What is the delivery lead time of that equipment? When will it be qualified? During their last process simulation, what were their findings? Did they have any issues? Have they had any recalls? Why? What was the root cause and was it corrected?
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 if the CMO has the correct fit of technology and expertise. Questions to ask include: Does your product have special handling or temperature requirements? Is the product susceptible to foaming or clumping? Is the product shear sensitive? Is the product uniform or homogenous, or does it require some type of mixing or blending? What is the sensitivity to bio-decontamination or cleaning chemicals? Is the product highly viscous, temperature-, light-, or oxygen-sensitive? Is the product a controlled substance? Is the CMO set up to handle this type of end product? If the product has to be re-circulated, does the CMO have the right in-line process equipment? What does that cost? Is it included in the proposal cost? How automated will it be? What controls are in place to prevent excursions? How much experience does the CMO have with this kind of technology or these types of products?
Operator Exposure Limit (OEL) 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 used exclusively for their runs. Drug products created for specific high-risk populations may have additional containment requirements as well. Make sure that 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 in achieving 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 is actually 20 years old? How will they replace a spare part if needed? Are the controllers on the machine even available for purchase or are they shopping online bidding sites trying to find replacement parts?
Overall, the evaluation of a potential CMO should…..
The text above is owned by the site bellow referred.
Here is only a small part of the article, for more please follow the link