December 6, 2019 PAP-Q1-2019-CL-019
Whether a project is being rushed internally or has been given accelerated approval by the U.S. Food and Drug Administration (FDA), taking a drug to market quickly is one of the most challenging tasks that any contract drug manufacturing organization (CDMO) can face. Starting with research and continuing all the way through approval, drug development is both time and cost intensive. On average, it costs $2.6 billion to develop a successful drug.1 Only a select few drugs in development end up being approved; the clinical success rate of a drug is estimated to be approximately 12%.1 Beyond being extremely costly, bringing a drug to market is a notoriously slow process. It takes 10 years on average to complete the development of a new medicine.1
To help get drugs onto the market faster, the FDA has determined three types of drug designations — Fast Track, Breakthrough Therapy and Priority Review — based on the unmet need for treatments for the underlying conditions. Drugs receiving one or more of these designations means that the review process is streamlined and abbreviated, providing a significant benefit to the pharma company and the targeted patient population but also a potential manufacturing challenge, particularly for CDMOs competing for that business.
Fast-tracked projects can increase the pressure on what can already be intense purchasing situations, where even small differences in turnaround can have significant consequences in achieving delivery milestones. Secondary equipment suppliers like Federal Equipment Company can often help reduce this pressure better than original equipment manufacturers (OEMs) by having inventory in stock, ready for inspection and immediate shipping and installation.
The average lead time for new equipment — including selection, customization, factory-acceptance testing (FAT) and site-acceptance testing (SAT) — can range from six weeks to 24 months. This can prove exceptionally costly — and potentially unfeasible — when trying to re-outfit a facility and deliver final goods under a fast-tracked timeline, reducing the competitiveness of a CDMO in bidding for such accelerated projects. When dealing with OEMs outside of the United States — for which issues with customs and international tariffs are routine — this timeline can become even more extended.
In addition to increased timelines set by the FDA, a drug maker can push for production speed internally, and is especially likely to do so if the drug has already been granted commercial status. Changing market conditions can create a sudden need for rapid increases in capacity. Contract manufacturing organizations must respond to these external pressures and update processes accordingly. As production revolves around machinery, in order to keep costs low but also meet the demands of the market by revamping operations, a CDMO is benefited by a partnership with a trusted used equipment supplier.
The secondhand equipment market can provide a wide range of readily available equipment to pharmaceutical companies and CDMOs, reducing the lead times needed for specification, delivery and installation. Working with a qualified used equipment supplier can lead to faster product launches, process upgrades, capacity expansions and critical equipment replacements, which can make or break a fast-tracked project itself or a CDMO’s ability to secure the program. Beyond decreased lead times, buying used equipment can significantly reduce capital expenditures — costs for used assets can be 40–70% less than new equipment.
With a constantly updated stock of the latest machines in major asset classes and an expert team that trains operators in how to manage their newly acquired equipment, Federal Equipment Company is a leading choice of partner when a facility needs to be upgraded. Federal Equipment Company provides machines that can be shipped within a week, which is unprecedented in an industry where much longer lead times are considered standard. We partner with top OEMs to assure that the right machine is selected and installed. To maximize both time and cost savings, the option of acquiring used, rather than new equipment, should be evaluated as early as possible during process design to maximize flexibility and avoid the time-consuming, costly design and specification stages involved in new equipment purchases.
At Federal Equipment Company, the breadth of knowledge that our experts bring to any deal and our comprehensive understanding of the equipment that we carry provide a wealth of additional value to our partners. We offer training for solid dose equipment via our partner Techceuticals in our tablet and capsule formulations lab — which is available for rent. We help customers better understand how to use equipment and get it into operation as quickly as possible and reduce issues once there.
Federal Equipment Company also offers decontamination services and validation for the used equipment we sell. Customers purchasing used equipment need complete assurance that the machinery presents no risk of cross-contamination. Conducting microbial testing and biological decontamination of equipment — before it is placed into service — offers peace of mind to customers who are worried about bringing an outside system into existing aseptic or controlled manufacturing conditions. Our three-step decontamination process assures that equipment is free from 99.9999% of harmful pathogens and contaminants, as well as beta-lactam antibiotics.
Our clients can take advantage of our turnkey solution to equipment removal. It is a hindrance to production when a company is encumbered by machines that are no longer useful. However, removing equipment takes precious time and requires expertise to assure that it is not damaged during the removal process; damaged equipment may be rendered inoperable and prevent its sale. When a fast-tracked project requires the procurement of new equipment and the divestment and removal of surplus equipment, a strategic equipment partner can eliminate the headaches associated with the many steps involved in updating a facility.
We can remove unneeded assets immediately and either purchase the equipment outright or sell it on consignment or at auction. Federal Equipment Company acts as the seller’s guide, presenting the best options for the seller and making recommendations after considering all factors, and bringing in the appropriate resources, including auctioneer selection, removal contractor, marketing plan and a well-developed list of equipment buyers.
When a CDMO is facing an abbreviated timeline — whether from the FDA or a sponsor organization — product management and optimization are key. Making sure that all equipment is accounted for and serves a purpose is crucial, especially when speed is prioritized. A trusted equipment dealer, such as Federal Equipment Company, can help smooth this transition in a timely and cost-effective manner, so that supplier organizations can effectively meet challenges associated with shortened timelines.
As the race to speed-up drug development continues, with more drugs being granted Priority Review, Breakthrough Therapy or Fast Track designations — and more expected in the near future, especially as cell and gene therapies advance from the clinic into the commercial realm and as biologic therapies continue to maintain their blockbuster status — production timelines will be expected to decrease. Owing to the high cost of research and development for new drugs, CDMOs that partner with a trusted equipment dealer and reduce production costs by relying on used machinery will not only improve their timelines but also build their reputation in the industry. By partnering with a reliable equipment supplier, companies are reducing costs, saving time and optimizing their means of production.
“Biopharmaceutical Research & Development: The Process Behind New Medicines.” PhRMA. May 2015. Web.
Justin Kadis works in marketing and business development for Federal Equipment Company, a major supplier of used manufacturing equipment for a wide variety of industries. He graduated from Boston University with a Bachelor of Science in Business Administration degree with a concentration in marketing.