AMPAC Fine Chemicals

SK pharmteco

Center of Excellence

Continuous Processing

COVID-19

High Potency

Integration

Q2 2020

Quality

SK Pharmteco

<h3><span style="color: #ee7624;">The COVID-19 pandemic has highlighted the need for modifications to the pharmaceutical supply chain. SK pharmteco is a global CDMO with integrated service offerings across the development spectrum in Asia, Europe, and the United States. An underpinning commitment to safety and quality, combined with core competencies in several specialized technologies that support the process development and manufacture of structurally complex molecules, highly potent compounds, and controlled substances, further solidifies the company’s position in the pharma supply chain.</span><span style="color: #ee7624;"></span><span style="color: #ee7624;"></span></h3>
<h4 class="p3"><span style="color: #c61c2c;">Building a Global CDMO Business </span></h4>
<p class="p3">SK pharmteco was established in 2019 by SK Holdings following the acquisition of AMPAC Fine Chemicals (AFC) and AMPAC Analytical, which were combined with SK biotek Korea and SK biotek Ireland. At present, SK pharmteco has six production plants in the United States, Ireland, and South Korea, one analytical testing facility, and a wide array of enabling technologies.</p>
<p class="p3">Headquartered in California, SK pharmteco unites the marketing and business development activities under one umbrella to leverage our global capabilities, technology toolbox, and our ONE Team mentality. Indeed, SK pharmteco supports the entire supply chain, from registered raw materials to final APIs.</p>
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<h4 class="p3"><span style="color: #c61c2c;">Foundational Commitment to Safety and Quality </span></h4>
<p class="p3">SK pharmteco is a global contract manufacturer, but our roots and culture are derived from the experience of each individual company: AMPAC Fine Chemicals, SK biotek Korea, and SK biotek Ireland. This combined perspective helps drive the priorities of our overall organization, including our overarching commitment to maintaining high levels of safety and quality. While each of the businesses within SK pharmteco brings different technological capabilities to the table, from continuous flow manufacturing to highly potent and controlled substance handling and simulated moving bed (SMB) chromatography, our commitment to quality and safety underpins everything that we do at SK pharmteco and defines our business.</p>
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<h4 class="callout-title"><span style="color: #ec9122;"><span style="color: #ee7624;">SK pharmteco is a global contract manufacturer, but our roots and culture are derived from the experience of each individual company: AMPAC Fine Chemicals, SK biotek Korea, and SK biotek Ireland.</span></span></h4>
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<h4 class="p3"><span style="color: #c61c2c;">A Centers of Excellence Approach </span></h4>
<p class="p3">The companies joined under the SK pharmteco umbrella have each been individually successful and have maintained their individual identities, cultures, processes, and organizational structures despite being part of the larger group. We are finding synergies by sharing best practices in manufacturing; lean processes; quality; environmental, health, and safety (EHS); and core competencies overlap. SK pharmteco has created several centers of excellence to facilitate collaboration among the various businesses within the group. These centers can be considered representative departments of a CDMO, such as research and development, operations, EHS, quality, and finance. The respective leaders of each department work closely together to ensure seamless interactions and support.</p>
<p class="p3">We are here to create value for our customers and, ultimately, for SK pharmteco. By looking at our combined businesses from the customer’s perspective, we are able to identify opportunities to integrate our strengths to provide value-driven solutions for our customers.</p>
<h4 class="p3"><span style="color: #c61c2c;">Several Core Competencies </span></h4>
<p class="p3">SK pharmteco has a rich history in continuous processing, both at SK biotek Korea and AMPAC Fine Chemicals, although each company has developed expertise in different aspects of this technology. One of AFC’s particular areas of expertise is SMB chromatography. AFC offers this capability from grams to hundreds of metric tons. The technology is used for purification of complex molecules, including the separation of chiral materials, which are increasingly common. Further, continuous chromatography is ideal for the separation of more complex compounds with tight specifications.</p>
<p class="p3">Looking forward, continuous processing will play a key role in pharmaceutical manufacturing. In addition to enabling the use of hazardous chemistry that is unsuitable under batch conditions, significant costs can be driven out of pharmaceutical production. SK pharmteco will, therefore, continue to invest in additional technology and equipment, enabling the development of new continuous processing solutions.</p>
<p class="p3">SK biotech Ireland and AFC both have decades of experience in the process development and manufacture of highly potent compounds, which are becoming increasingly prevalent in the pharmaceutical pipeline. Many targeted therapies in oncology and a widening array of other indications have much greater complexity and higher potency, allowing for lower dosages.</p>
<p class="p3">SK pharmteco is well positioned to apply the specialized equipment needed to ensure effective containment during the production and handling of highly potent compounds. In addition to a rich history in cytotoxic chemical production, we have added to our capacity and the engineering controls in all of our facilities. As the pharma industry continues to move toward smaller-volume, higher-potency treatments, we will continue to invest in additional capacity and containment solutions.</p>
<p class="p3">With its foundations in the aerospace industry, AFC has a stellar reputation in the manufacture of substances using various types of energetic chemistry. We have also established expertise in material science and can offer comprehensive support with respect to polymorph and particle size control.</p>
<p class="p3">We also have a successful history of producing controlled substances for the U.S. market. AFC has the capacity to produce these materials from small to large scale. With our licensed facilities and experience complying with controlled substance regulations, we can help customers negotiate the complexities involved with development, approval, and commercial manufacture of their therapeutic compounds.</p>
<p class="p3">AFC also has established best-in-class dedicated analytical services facilities in California. We have invested in specialized equipment, such as inductively coupled plasma mass spectrometry (ICP-MS), inductively coupled plasma optical emission spectrometry (ICP-OES), and X-ray powder diffraction (XRPD).</p>
<p class="p3">As the overall demand for testing increases, we will continue to expand our capabilities to support changes in the industry. For instance, we are well-suited to perform specialized impurity testing for N-nitroso dimethylamine (NDMA) and related contaminants in both drug substances and drug products.</p>
<h4 class="p3"><span style="color: #c61c2c;">High-Quality Supplier </span></h4>
<p class="p3">Having expertise in various technologies is not sufficient to be a competitive CDMO. The combination of our complex chemistry, engineering, and material science knowledge with our commitment to quality and safety set us apart from other service providers. We have developed a high level of competency in process development and scale-up, technology transfer, and clinical and commercial manufacturing and serve as a true partner for our customers in the regulatory approval and inspection process.</p>
<p class="p3">We understand the validation process, and many customers come to AFC specifically for development of the CMC sections of their regulatory filings. Many emerging and smaller biopharma companies — firms that are driving much of the innovation in the industry today — need a manufacturing partner that will not only meet the expectations of regulatory authorities but can offer current guidance on the development of the CMC section. SK pharmteco has the full range of capabilities needed to provide these innovative organizations with the comprehensive support they require.</p>
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<h4 class="callout-title"><span style="color: #ec9122;"><span style="color: #ee7624;">The companies joined under the SK pharmteco umbrella have each been individually successful and have maintained their individual identities, cultures, processes, and organizational structures.</span></span></h4>
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<h4 class="p3"><span style="color: #c61c2c;">Responding Quickly to the COVID-19 Crisis </span></h4>
<p class="p3">The COVID-19 pandemic has created a tragic and devastating situation for the entire world. During this crisis, the safety of our people has been and continues to be our first priority. Each business entity is operating within the guidelines mandated in their particular areas. From a manufacturing perspective, we are experienced in operating in high-containment areas. Because we work with hazardous materials and produce energetic and potent compounds, our workforce is adept at applying personal protective equipment and other measures necessary to ensure safe operations. As needed, we have made additional adjustments, such as shift changes and personnel flows, to ensure that proper social distancing is maintained.</p>
<p class="p3">Our office staff has transitioned seamlessly to digital platforms and working remotely. Before the pandemic, we routinely conducted online, virtual meetings with customers. Today, we are simply applying these solutions more broadly. Our other priority is ensuring that the ongoing supply of essential drugs is maintained for patients around the world. To that end, we continue to monitor supply lines and supply chains. Thus far, the fine chemical manufacturing sector is performing well, but we have taken measures to ensure uninterrupted supply to customers as we go forward. The rapid response of our executive teams has enabled SK pharmteco to achieve uninterrupted operations throughout the COVID-19 crisis.</p>
<h4 class="p3"><span style="color: #c61c2c;">Supporting COVID-19 Development Efforts </span></h4>
<p class="p3">We are also looking forward to several projects designed to support the pharma industry and the development of potential COVID-19 therapeutics. AMPAC Fine Chemicals has joined a strategic relationship with Phlow, a U.S.-based, public benefit drug manufacturing corporation, Civica Rx, and Virginia Commonwealth University’s Medicines for All Institute to address potential shortages of essential medicines in the United States, including medicines for the COVID-19 pandemic response.</p>
<p class="p3">The project is funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (DHHS). It aims to provide domestic manufacturing of chemical precursor ingredients, active pharmaceutical ingredients (APIs), and finished dosage forms for over a dozen essential medicines to treat hospitalized patients with COVID-19–related illnesses, many of which are in short supply and have previously been imported from foreign nations. Phlow is working with AMPAC Fine Chemicals to produce ingredients used for the production of these essential medicines.</p>
<p class="p3">SK pharmteco is also supporting a number of clinical trials with existing drugs that may be potential COVID-19 therapies. Volumes have increased and/or timelines have shortened for the production of clinical materials needed for these trials. We are working closely with customers to get the materials to them as soon as possible and enable clinical trials.</p>
<h4 class="p3"><span style="color: #c61c2c;">Preparing for a New Normal </span></h4>
<p class="p3">Once we are successful in developing effective therapies, how we move forward will become crucial. We will need to find solutions that ensure continued protection of our workforce and ensure that our businesses adjust to the “new normal.”</p>
<p class="p3">SK pharmteco is a service provider. We want to remain open to visits from our customers so they can witness the ability of each of our sites to deliver. At the same time, we must make sure that both our employees and our customers are safe in the new environment. As guidelines are rolled back, we will continue to modify our operations with an eye to the future while ensuring everyone’s safety.</p>
<p class="p3">Going forward, we will need to find a balance between face-to-face and virtual meetings. Our customers will have their own policies with regard to travel and in-person interactions. We expect to conduct the majority of meetings virtually, but will also establish policies and procedures to enable onsite visits.</p>
<h4 class="p3"><span style="color: #c61c2c;">COVID-19 Impact on Manufacturing </span></h4>
<p class="p3">Beyond the need to revise day-to-day operations to protect employees and customers from exposure to the novel coronavirus, the COVID-19 pandemic will have broader implications for the pharmaceutical supply chain. It has shed light on how the industry is organized from a manufacturing perspective. There have been discussions about this issue for several years, but now the potential consequences are much more tangible.</p>
<p class="p3">Many key pharma raw materials and intermediates are produced by suppliers in India and China, with final drug substances and drug products manufactured in Europe or the United States. This single supply chain provides the bulk of medicines consumed around the world; any major interruption can rapidly lead to shortages of critical drugs. Efforts have already begun — such as the strategic initiative that AFC is involved in as described previously — to establish an overall integrated, well-understood supply chain solution that can ensure the ongoing supply of medications in the event of future pandemics or other global crises, but without complicating the issue with politics.</p>
<p class="p3">SK pharmteco is well positioned to participate in such an integrated supply chain. With manufacturing locations in South Korea, Ireland, and the United States, our geographic locations provide an integrated solution that many other CDMOs cannot offer.</p>
<h4 class="p3"><span style="color: #c61c2c;">Renewed Focus on Social Responsibility </span></h4>
<p class="p3">In addition to safety and quality, the happiness of our employees, neighbors, customers, shareholders, and regulators is an important priority for SK pharmteco. Our focus on happiness has measurable results: the business runs more smoothly, grows more rapidly, and helps get needed medicines to patients more quickly.</p>
<p class="p3">During the COVID-19 pandemic, our focus on social responsibility has had additional benefits for our employees and communities. The experiences we have all shared at SK pharmteco, particularly at the site-level, have made us stronger.</p>
<p class="p3">The response from our employees has been quite impressive. They have sought opportunities to partner with their communities and find ways to provide assistance. Many have worked to aid frontline workers. Going forward, we will seek to do more. We are excited to partner with local community leaders to identify additional opportunities where we can contribute. Indeed, doing so will lead to greater happiness all around.</p>

Creating Value through Best Practices Across a Global, Integrated Service Provider