SK pharmteco
Maximizing Pace and Innovation in Drug Development

Operational excellence is a top criterion for pharmaceutical companies looking to develop life-saving therapeutics. This is precisely why they need the right contract development and manufacturing organization (CDMO) that can help them fast-track the development process and bring critical drugs to market in a reliable and affordable manner.

For eight decades, SK pharmteco (SKPT) has been helping pharma and biotech organizations deliver breakthrough medicines to patients through technical excellence, a global presence, and an unwavering focus on innovation, quality, and safety.

Specializing in commercial and clinical production of small molecule intermediates and APIs, as well as viral vectors for cell and gene therapies, SKPT offers a wide range of services to help clients accelerate their clinical development process.

“We have a long track record of helping pharma and biotech companies effectively bring their drugs to market by increasing efficiency in their product development lifecycle,” says Joerg Ahlgrimm, CEO of SK pharmteco.

An All-Encompassing Skillset

The company supports clients at every stage of their development lifecycle by harnessing its expertise in energetic chemistry, continuous flow processing, chromatography, particle engineering, viral vectors, ADC payloads, linkers, and oligonucleotides. With expertise in these sophisticated methodologies, it assists clients in R&D, analytical method development and stability, process scale-up and optimization, validation, and commercial production.

SKPT offers adeno-associated viral (AAV) and lentiviral vector (LV) development and CGMP production for the expansion into novel therapies and treatment options.

In the preclinical phase, SK pharmteco helps clients develop a well-organized R&D pipeline before initiating Phase One manufacturing. This is followed by support for late phase clinical trials and validation, fulfilling additional material requirements for the project and enhancing operational excellence to scale their entire operations.

In these days when pharma and biotech companies often struggle with shortening product development timelines and faster time to market, SK pharmteco’s robust processes, backed by a deep understanding of best practices, help clients quickly create high-quality validation campaigns for accelerating product approvals.

In a recent collaboration with a client, SK pharmteco implemented a 9-step chemical process for an oncology drug, moving the product from the development stage to manufacturing in 99 days, with validation completed in 106 days.

On another occasion, SK pharmteco partnered with a company to fast-track approval of an antiviral medicine. It followed a 5-step process to manufacture the product within 29 days and validate it in 129 days.

SK pharmteco also assists clients in mitigating risk within their product development pipeline by complying with different regulatory requirements. SKPT maintains high standards of environmental, health, and safety performance, and all its plants have been successfully audited by global regulatory agencies, including the FDA (U.S.), EMA (Europe), PMDA (Japan), and MFDS (Korea). SKPT has gained such a level of recognition in the regulatory space that it trains FDA personnel at its U.S. subsidiary.

The Global Reach

Apart from its unrivalled technical capabilities and scientific prowess, SK pharmteco’s global footprint brings significant advantages to its clients.

It operates six CGMP manufacturing and development facilities across the U.S., Korea, Ireland, and France, four R&D centers, and four analytical services facilities. Through its global operations and an international network of partners, SK pharmteco provides clients end-to-end supply chain integration and efficiency.

SK pharmteco’s vast network of partners allows it to effectively source key raw materials and intermediates from regions where they are produced. It then processes these materials in its manufacturing facilities to provide products to customers under the highest quality standards.

We have a long track record of helping pharma and biotech companies effectively bring their drugs to market by increasing efficiency in their product development lifecycle

Bringing Collaboration to the Forefront

The best description of SK pharmteco’s organizational culture is ‘customer-centricity.’

“Our company culture enables all employees to work in sync with their clients’ requirements and ensure the best possible outcome for them and, subsequently, patients,” states Ahlgrimm.

Within the organization, SK pharmteco follows a ‘one team’ mindset where all team members, regardless of geographical location or department, work together as a cohesive unit to foster teamwork, open communication, and inter-disciplinary collaboration.

Relentlessly striving for excellence, SK pharmteco strongly values customer feedback. This allows it to constantly improve and optimize the quality of its offerings.

It also promotes an open-door policy when partnering with clients. Whenever a problem is encountered, SKPT teams ensure that the customer is immediately brought to the table.

When a client needs support, SKPT assembles a team to gain a clear understanding of the issue and resolve it as quickly as possible, while offering transparency and open communication with the client.

A Zeal for Innovation

SK pharmteco focuses on continuous innovation to further strengthen its expertise across multiple modalities. It remains aware that every ground-breaking medical discovery unfolds a world of revolutionary therapies that can elevate the standards of patient care. SK pharmteco stays abreast of the most recent industry developments and is on the lookout to support and incorporate the latest technological innovations into its workflow and make them accessible to clients.

SK pharmteco has been investing in new capabilities to support complex small molecule chemistry. It has opened an engineering center in California for research and development activities around complex drugs with an emphasis on continuous processing.

Together with this venture, it is implementing a project to develop antibody-drug conjugates at an advanced high containment facility in Ireland. Simultaneously, it is building a special capability in oligonucleotide development to broaden its expertise.

SK pharmteco’s appetite for innovation is highlighted by its recent investment in building a 700,000-square-foot facility in Pennsylvania and a 100,000-square-foot facility in Europe. These CGMP facilities are focused on the development and manufacture of viral vectors with CGMP development and commercial Cell Therapy capabilities in the US.

Committed to expediting the drug development lifecycle for various pharma organizations, SK pharmteco offers an integrated chain bundled with all analytical tools needed to implement a particular process. Where pharma companies currently spend 18 months with three to four CDMOs and six to seven testing organizations to produce APIs, SK pharmteco can deliver all the capabilities through a single source within five to six months.

Building on its decades of experience in providing CDMO services for developing APIs, SK pharmteco helps its clients obtain a significant advantage in manufacturing life-saving medicines. Through efficient clinical development and continuous innovation, it keeps delivering innovative solutions that empower millions to live healthier lives.