Life Sciences

SK pharmteco: a unified approach to supporting pharma and biotech manufacturing

By In partnership with

In an exclusive interview for Life Science Integrates, Aslam Malik, CEO, explains how SK pharmteco has become established as a single customer-facing team offering a synergistic combination of complementary manufacturing services to support pharmaceutical and biotech product manufacture.

LSI: How and why was SK pharmteco established in its present form and what specifically is its mission?

AM: SK pharmteco, a wholly owned subsidiary of South Korean conglomerate SK Inc, was established in January 2020 to become the single customer-facing team comprised of SK biotek Korea, SK biotek Ireland, AMPAC Fine Chemicals and AMPAC Analytical, while in March 2021, Yposkesi was added to the SK pharmteco family, allowing us to enter the cell and gene therapy market. This creates substantial market synergies by combining the highly complementary assets and expertise of these companies, further enabling us to provide the highest quality services to our customers.

Our mission is to partner with our customers to develop and reliably deliver pharma products through manufacturing and technical excellence with a workforce committed to safety, quality, and innovation. Our vision is to be the most trusted global partner in the manufacture and testing of medicines and we accomplish this by reliably delivering pharmaceutical products that benefit patients and communities around the world. SK pharmteco achieves manufacturing and technical excellence through its skilled workforce and commitment to safety, quality, and innovation.

LSI: Can you give more details on the technologies, facilities and market niches of these individual businesses?

AM: SK biotek Korea was established in 1996 and is a leading supplier of late-phase and commercial pharmaceutical materials using continuous processing, which is more efficient and cost-effective than batch processing and is fully supported by the FDA and other regulatory agencies. Continuous processing allows certain chemical transformations that are difficult to do in batch, such as low-temperature, hazardous reagents (azide, hydrogen peroxide, etc.), high-pressure (300 atm), high-temperature (600°C) and various catalytic reactions to be conducted in a safe and reliable manner. SK biotek Korea has two state-of-the-art plants in Sejong and Daejeon: the Sejong site is currently amid a major expansion that will double its capacity.

SK biotek Ireland was formed in January 2018 via the acquisition of a former pharma facility at the Swords Campus, Dublin. It has been manufacturing APIs and intermediates for almost 60 years: Leaders in operational excellence and continuous improvement, it is the birthplace of some of the world’s leading therapeutics. The Swords Campus has built exceptional technical capabilities with extensive experience in custom development from clinical phases to commercial scale-up and launch. For the past 30 years, the Swords Campus has maintained leadership in the development, scale-up and commercial manufacture of highly potent chemical intermediates and APIs (HPAPIs), capable of handling material with an Occupational Exposure Limit of (OEL) ≥ 10 nanograms per cubic metre, 10,000 times lower than the generally accepted limit of ≤ 100 micrograms per cubic metre for highly potent compounds.

AMPAC Fine Chemicals (AFC) became part of the SK family in September 2018, expanding SK’s manufacturing footprint to the US. AFC is a custom manufacturer of APIs and intermediates and has been solving problems for customers through technology and innovation to reliably deliver quality products for over 80 years. With integrated facilities in California, Texas, and Virginia specializing in process development, scale-up, and cGMP-compliant production from kilograms to multi-ton quantities, AFC has developed capabilities that support a wide range of processes and technologies that includes chromatography, HPAPI, continuous processing, and the safe implementation of highly energetic chemistries. AMPAC Analytical, an independent subsidiary of AMPAC Fine Chemicals, delivers all analytical requirements for APIs, intermediates, and formulated drug products, from analytical method development and implementation to analytical method validation and stability. It is equipped with cGMP-compliant instrumentation geared towards product analysis and product release. AMPAC Analytical supports spectroscopy, chromatography, particle size distribution, calorimetry, osmolality, mass spectrometry and ICH stability project requirements.

Yposkesi is a full-service CDMO, bringing 30 years of innovation and successful development as one of the largest gene therapy CDMOs in Europe through all stages of development and manufacture. With four independent viral vector production suites and two independent aseptic fill and finish lines, Yposkesi is a leader in the development and production of high-yielding processes for both AAV and LV vectors. We are also in the progress of expanding our production capacity to include an additional 45,000 sq ft cGMP commercial manufacturing space.

As part of the SK pharmteco family, SK biotek Korea, SK biotek Ireland, AMPAC Fine Chemicals, AMPAC Analytical and Yposkesi provide our customers a broad portfolio of offerings. Each company maintains their individual heritages and relationships that customers have come to trust. But they also have the advantage of a global network of support that allows them to take advantage of common best practices and the strengths of a big company. With over 1000 cubic metres of small-molecule manufacturing capacity globally, across three continents, we have the capacity to manufacture APIs, intermediates and HPAPIs from grams to multi-tons across the full product lifecycle. With the 5000 sq m of viral vector capacity, in the heart of Europe, we have the capacity to handle process development to commercial launch of all gene therapy requirements. SK pharmteco is here to serve all its customers’ small molecule and viral vector needs.

LSI: Which of the company’s main business areas accounts for most of SK pharmteco’s business, which is the fastest growing, and which one offers the best prospects for commercial success for SK pharmteco in the current business climate?

AM: Currently, custom manufacturing accounts for the most of our business and continues to provide a strong foundation of our commercial success. We are uniquely positioned to take advantage of the growth being experienced in the production of HPAPIs, the provision of analytical services, the adoption of continuous processing and the ever-expanding field of bioprocessing.

LSI: How many collaborative agreements do you have at present and how many new ones are you looking to establish over the next few years?

We seek to stabilize our business through the implementation of long-term agreements with our customers, whom we view as partners and collaborators. It is well-understood within the industry that such agreements are highly confidential. Our goal is to achieve 80% of our revenues from projects with long-term agreements. We use forecasting mechanisms and minimum volume commitments in these long-term agreements to ensure our customers that we can provide what they need and when they need it so they can be best positioned to meet the challenges of demand volatility.

LSI:Are there any recent business or technical developments within SK pharmteco that you would like to highlight?

Total ongoing global capacity and capability expansion activities include an additional 395 cubic metres in small-molecule manufacturing capacity and 5,000 sq m of viral vector drug substance manufacturing capacity.We are also expanding existing manufacturing technologies including continuous processing, HPAPI, energetic chemistry and solid-state processing as well as viral vector capabilities for both AAV and LVV platforms.

Our AFC Virginia plant is the centre of excellence for controlled substances and US Government API supply. We are expanding commercial production by activating 81 cubic metres of capacity, adding a dedicated analytical services laboratory and supporting manufacture of essential medicines for US healthcare providers.

Our AFC California plant is the centre of excellence for chromatography and energetic chemistries. We are duplicating an 18,500 gallon/70 cubic metre asset to support a growing pipeline of products newly ‘graduated’ from development to commercial status and adding additional HPAPI processing to support new and expanded drug candidates. A new pilot plant (300-gal suite) has been completed to support increased development programme demands and we have also expanded our milling suites.

Our AFC Texas plant is the centre of excellence for hydrogenation, phosgenation, azide, and nitration. We are also installing a 4 cubic metre Hastelloy filter dryer to enhance parallel processing and multi-product capability.

SK biotek Ireland’s Swords Campus is the centre of excellence for HPAPI and material science. We have increased the reactor capacity by 15% at this site with appropriate solids handling. There has also been an enhancement of the HPAPI reactor charging equipment, an expanded plant Delta V control system, as well as new lab-scale spray-drying and jet-milling capabilities.

Our Korea plants are the centre of excellence for APIs and Registered Intermediates and a focus for continuous processing. We are amid an expansion to support growth of existing product volumes plus an additional expansion planned for 2023 of our existing manufacturing capabilities.

Our Paris facility is the centre of excellence for viral vector and gene therapies. We are currently doubling our viral vector manufacturing footprint at this location

LSI: What is SK pharmteco’s business strategy to continue competing and to prosper in the highly competitive custom chemical and API manufacturing business environment?

AM: A key success factor we have achieved over the recent years is diversification. Our businesses are geographically diverse spanning North America, Europe, and Korea which helps minimize shock against regional economic pressures and allows us to best capitalize on positive opportunities at a regional level. We also have diversity in terms of our offering, supporting both the small-molecule and viral vector sectors, and are therefore well positioned to react to future trends in pharmaceutical drug development. We would anticipate maintaining and indeed enhancing such diversification through future M&A activity.

It is also important to maintain some diversity in terms of the partnerships that sustain our business. There have been historical issues where service providers were heavily dependent on a single customer for revenue. A change in the fortunes of this customer or simply a change in the outsourcing approach would have damaging implications for the service provider, therefore, it is important to strive for diversification in the customer base.

In comparison to many other sectors, the pharma services sector remains relatively robust against global economic volatility. There will always be successes and failures but the outlook looks positive for companies like ours that operate to the highest of standards and consistently deliver on our commitments to our customers.

LSI: Similarly, many companies offer bioprocess development and manufacturing services, what are SK pharmteco’s strategies for achieving commercial success in this competitive sector?

AM: We will continue to build off the success and expertise that we have developed over the past decades and use our relationships and client base to continue to expand and grow in this space. We are looking to back-integrate into the supply chain as well as expand into the area of fill and finish. We also plan to build upon the expertise within the global familyby leveraging our knowledge in the areas of regulatory support as well as an expansion of our analytical services business to include viral vector testing.

LSI: What are the (bio)pharmaceutical industry’s prospects over the next decade and the implications for SK pharmteco?

AM: Our overall view in this area is that there will still be consolidation/M&A as larger well-funded pharma companies continue to acquire products, technologies, and capacities. It is unlikely that this has bottomed out at this time. Also from a global perspective, we have moved past a COVID management phase, and many sectors of the economy are starting to lift. Both factors would argue for a continuation of M&A and/or consolidation activity.

From an SK pharmteco perspective, the pharma industry will continue to outsource activities to CDMOs, where they need additional capacity, access to technologies or to prioritize their own internal capacity for specific products. The situation with cell and gene therapies is quite dynamic and will continue to be so for several years. Many companies are now entering this space, but do not have the appropriate capacity or technologies. This may lead to buy-outs or consolidation in some cases, but also stronger relationships between pharma/biotech companies and CDMO partners. SK pharmteco is a trusted and reliable CDMO partner for small molecule-based processes, and we are now further expanding into cell and gene therapies: we see many years of continued fruitful collaboration with our pharma partners.

LSI: Is there a concluding statement you would like to make?

AM: Like every family with good lineage and a long history built on strong values like ours, our entrepreneurial spirit, innovative mindset, flexibility, and focus on results leads to expansion and growth as second nature.

Key marketing buzzwords you will frequently encounter in the industry are customer service, global footprint, capacity, longevity, experience, safety and quality record, reputation, technical competency, etc. At SK pharmteco, these are not marketing buzzwords but our ways of working and have been developed over the past 80+ years. We have a global footprint across three continents: seven facilities with almost 1000 cubic metres for small-molecule manufacture and 5000 square metres in viral vector capacity. These are all state-of-the-art plants and laboratories with a strong technology toolbox that is second-to-none and run by our talented workforce of over 1500 employees.

Working with us as a small or viral vector CDMO ensures support from development to launch to commercial manufacturing. Despite our growth, our values are steadfast and are the pillars our growing business is built on.We value the relationships we have with our customers, employees, and suppliers. It is a relationship that is built on respect and relies on clear expectations, communication, and trust. Using scientific and technical understanding, practical experience, and commitment, we put ourselves in our customer’s shoes and understand the long, complex journey they are on, and apply a science-driven, risk-based approach at every step. This is where our size matters in offering an added sense of security, knowing we are certified in cGMP and are regularly audited by the FDA and leading regulatory authorities, and have not only the resources, expertise, capacity, capability but also long-term viability to form lasting relationships and bring multiple projects to market.

Our entrepreneurial spirit means we are constantly looking for new ways, services, and capabilities to enhance our offering to our customers. Our ambition is to be a leading integrated development and manufacturing partner for the global pharmaceutical market, meeting all pharma needs: whether the customer is looking for a CDMO specializing in viral vectors, high potency APIs, continuous processing, energetic chemistry, controlled substances or chromatography, or simply looking for a partner that offers a secure development pathway for an NCE or commercial product, we would be delighted to work with such a customer.