Case Study Hanmi

Success criteria:

• Eight module crossflow systems
• Stacked cassette holders for small footprint
• Capable of delivering high cleaning flowrates and low processing flowrates
• Utilizes readily available components

Project duration:

• Approximately 15 months

Provided Solutions:

• 4 x Sartoflow^® 600 crossflow systems  for 120 x 3.5 m2 Sartocube^® modules and an a 4,000 L recirculation tank
• 2 x Sartoflow^® 120 crossflow systems  for 24 x 3.5 m2 Sartocube^® modules and an a 600 L recirculation tank
• 2 x Sartoflow^® 40 crossflow systems  for 8 x 3.5 m2 Sartocube^® modules and an a 800 L recirculation tank

Biomanufacturing Capacity Expansion

Hanmi Pharm is a Korean pharmaceutical company with headquarters in Seoul. It is a pioneer in developing ‘first-in-class’ drugs in partnership with leading global pharmaceutical companies. In 2015, Hanmi Pharm and Sanofi announced a major licence agreement to develop a portfolio of long-acting diabetes treatments. The agreement covered projects that utilize Hanmi’s proprietary LAPSCOVERY Long Acting Protein / Peptide Discovery Platform. To meet market demand for the long-acting diabetes treatments, Hanmi needed to scale-up production of their Long Acting Protein (LAPS) carrier from 1 tonne/year to 20 tonnes/year. During a subsequent processing step the LAPS carrier is conjugated to the therapeutic agent. During treatments the LAPS carrier guides the therapeutic agent to target cells within the patient’s body. 
Hanmi Pharm built a new facility at their Gyeonggi-do production site and installed two 10,000 L fermenters to produce the LAPS carrier making the Pyeongtaek Complex the nation’s largest pharmaceutical production complex. The purification of the LAPS carrier requires three separate ultrafiltration steps requiring 1,680 m2, 56 m2 and 168 m2 of membrane area, respectively. The company needed a supplier that was capable of designing and delivering such large-scale systems for this uniquely ambitious project.

Selecting a Supplier with Crossflow System Expertise

Hanmi Pharm selected Sartorius Stedim Biotech (SSB) as the supplier of their large-scale crossflow systems. Sartorius’ Integrated Solutions team has a strong track-record with similar projects and has previously installed a Sartoflow^® 240 in Korea in 1999 that is still used today. Since this project, SSB had developed designs for larger systems and it was able to leverage these efforts when Hanmi Pharm requested a proposal for the skids to be installed in their new facility. During the vendor selection process, SSB demonstrated their superior expertise and experience by being able to pre-empt challenges in the design of such large-scale systems and proactively propose solutions.
Sartorius Integrated Solutions developed a clear understanding of commercially available system components that would fit with the large diameter pipework needed for such a system while meeting the quality specifications of the project. This knowledge facilitated the design of the systems while ensuring a supply chain was readily available to provide spare parts for the future.
To solve an additional challenge, SSB engineers used their experience from previous projects to develop a design that would meet the specified cleaning flowrates of 1.5 m/s while also allowing product processing at a significantly lower flowrates to prevent shear forces damaging the protein.
The project team, composed of engineers from both Hanmi Pharma and SSB, worked closely together on the project. Hanmi Pharma trusted the expertise of SSB and provided their selected supplier a clear understand of the LAPS carrier process, allowing the SSB engineers to develop a deep knowledge of their client’s requirements. The joint project team successfully adhered to ambitious project timelines ensuring the on time delivery of the crossflow systems.

Background Information

Project Manager: Andreas Weinmeister, Sartorius Stedim Biotech

Hanmi Pharm was established in 1973 with a motto ‘to develop better drugs for precious lives’ and to advance to the global market as a representative of the Korean Pharmaceutical industry by focusing on R&D. Hanmi Pharm has achieved the first and greatest new drug licensing deal since 1989, and became a pioneer of developing first-in-class drugs in collaboration with global leading pharmaceutical companies.

Hanmi makes strenuous and enthusiastic efforts to develop treatments for diabetes, obesity, cancer, autoimmune and rare disease to keep everyone’s health and improve their quality of life.

The company has received GMP certifications from food and drugs authorities of developed countries and also strives to promote public health by exporting finished products to global pharmaceutical companies based upon differentiated quality management.