Continuous Manufacturing

Equipment

High Potency

Q1 2016

Single Use

Used Equipment

<h3>In response to factors affecting drug pricing around the world — such as shifting markets, government healthcare mandates, the end of the blockbuster era, and the linkage of insurance reimbursement with medical outcomes — pharmaceutical companies are taking many different actions to reduce their costs and increase efficiency and productivity. Equipment needs across the supply chain are changing, from initial discovery efforts to the packaging of final products.</h3>
<p>The Nice Insight 2015 Pharmaceutical Equipment Annual Study found that 54% of respondents (n=560) spent over $100 million on equipment per year <strong>(See Figure 1)</strong>. And suppliers of research and development and production equipment, analytical instrumentation, and packaging systems are responding with innovative technologies that meet these needs.</p>
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<p>Single-Use Technology Single-use, or disposable, technology (SUT) is widely used in biopharmaceutical drug development, and more recently has begun to gain acceptance in biologics production at increasingly larger scales, including commercial manufacturing. This interest is driven by the advantages that SUTs provide in terms of decreased capital expenditures and operating costs due to the reduction of cleaning and sterilization steps and the need for validation. In addition, processes based on singleuse equipment are more flexible, require shorter set-up times, and have significantly reduced cross-contamination risk, all of which translates to a faster time to market and more robust and reliable production.</p>
<h4>Continuous Biopharmaceutical Manufacturing</h4>
<p>Continuous manufacturing is appealing because it leads to more consistent products and processes, which equates to the consumption of fewer resources (raw materials, energy, water) and less waste generation, thus lowering operating costs — capital costs may be lowered as well. For upstream biopharmaceutical manufacturing, perfusion has become a wellestablished process that affords high-quality biologic drug substances with high productivity. Other types of upstream equipment under development include continuous centrifuges, acoustic resonance devices, and cell settlers. For continuous downstream bioprocessing, simulated moving bed (SMB) chromatography and tangential flow filtration (TFF) systems are also available and being adopted by the industry.</p>
<p>Continuous Processes For Small-Molecule Drugs The industry has recognized the value of flow-through chemistry for the production of active pharmaceutical ingredients (APIs) and continuous tableting for many years. In addition to enhanced process and product consistency, flow chemistry enables manufacturers to perform hazardous reactions or use challenging conditions not possible in traditional batch modes. Reduced resource consumption and waste minimization are additional benefits, as with continuous biopharmaceutical processes, above.</p>
<h4>High Potency</h4>
<p>One of the fastest-growing segments of the pharmaceutical market comprises formulated drugs based on highly potent active pharmaceutical ingredients (HPAPIs). This rapid growth is largely attributed to the growing number of antibody-drug conjugates (ADCs) that have recently been approved or are in development. These drugs are attractive because they are targeted therapies that deliver highly potent and often cytotoxic drugs (payloads) to selective sites in the body, linking them to antibodies that are taken up by only specific types of cells with the right antigens. Because the active drug is only released at the site of action, ADCs can be delivered systemically without causing harm to healthy cells.</p>
<h4>Utilizing Used Equipment</h4>
<p>At the same time that demand for innovative equipment for continuous processing, single-use technology, and systems for the manufacture of highly potent compounds is being driven by the need to reduce costs and increase efficiencies, demand for used pharmaceutical equipment is also rising as the result of increased levels of industry consolidation and outsourcing. As large companies acquire smaller firms or merge with larger entities, they often turn to resource recovery (the sale of redundant facilities and surplus equipment) to achieve initial and ongoing cost savings. In fact, high-quality used equipment is often sold at 40%-50%, and sometimes as little as 20%, of the original price. In addition, used equipment is immediately available, compared to new equipment, which, in some cases, can take weeks or even months to obtain if back-ordered. Used equipment can also serve as cost-effective back-up materials for critical processes or can help keep a process running in the event of an unexpected equipment failure.</p>
<h4>Conclusion</h4>
<p>Taken together, these equipment trends are an effective response to the changing landscape of the pharmaceutical manufacturing industry across the supply chain. In addition to being pragmatic and cost effective, these revolutionary tactics have already yielded results for the many companies that have employed them. And with pharma equipment evolving at a rapid rate, decreased costs and greater efficiency will be the rule — not the exception — for drug companies going forward. The Nice Insight 2015 Pharmaceutical Equipment Annual Study found the following purchasing criteria to rank very closely for both Pharmas and Biotechs, as well as for CDMOs and CROs: Quality/Performance, Durability/Reliability, Regulatory/Validation, Price, Customer Service, and Service Agreement <strong>(See Figure 2)</strong>.</p>
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Equipment Trends Transforming Pharmaceutical Manufacturing