Viral Vector Manufacturing Services

SK pharmteco manufactures AAV, lentivirus, and adenovirus vectors, with capabilities spanning drug substance production, aseptic fill-finish, and analytical testing across facilities in King of Prussia, PA and south of Paris, France.

Upstream processing includes suspension and adherent cell culture systems, STR bioreactors (50–1,000 L), and iCELLis® 500 fixed-bed bioreactors. Downstream processing covers continuous clarification, TFF, chromatography, and ultracentrifugation, operated across segregated seed, upstream, and downstream processing suites.

The clonal HEK293 cell line — lead clone 4G9 — is engineered for high-yield production of AAV, lentiviral, and adenoviral vectors. It supports consistent production across multiple AAV serotypes (AAV1, 2, 5, 6, 8, 9) using established transfection methods, with master cell bank development underway to enable large-scale manufacturing and improved cost efficiency.

Both semi- and fully automated aseptic filling systems are available. The Bausch + Ströbel system supports qualified batch sizes up to 900 vials with zero-loss priming and 100% in-process weight checks. The VanRx Microcell isolator-based system supports the same qualified range, with potential for higher throughput as the qualified range expands. Supported container configurations include Schott glass nests (2R, 6R, 10R) and CZ nests (2 mL, 10 mL, pending qualification).

In-process, release, and characterization testing is available, covering DNA concentration and residual DNA, residual HCP and host cell RNA, endotoxin and compendial testing, capsid analysis (empty/full ratio), viral vector purity, vector-specific assays, and total plasmid quantification. Advanced sequencing capabilities include NGS and Sanger methods for plasmid sequencing.

Manufacturing infrastructure is structured to support technology transfer, process control, and scale-up at each stage. A dedicated MSAT team oversees these transitions, with bioreactor capacity scalable from bench scale to 1,000 L in the U.S. and up to 2,000 L in France, supporting batch volumes required for late-stage and commercial supply.

The King of Prussia site combines process development, CGMP manufacturing, analytical testing, and plasmid engineering within a single location, with three independent production suites and two aseptic fill-finish lines supporting bioreactor capacity up to 500 L, scalable to 1,000 L through multiplexing. The France facility is structured for higher-volume production, with six production suites, bioreactor capacity up to 2,000 L, and capacity for up to 72 batches annually, designed for late-stage and commercial supply.

The King of Prussia facility operates under FDA regulatory expectations and the France facility under EMA standards. Both sites run under CGMP with quality systems covering process control, technology transfer, and scale-up, supporting regulatory submissions across global markets.

Viral vector CDMO services typically cover process development, upstream and downstream production, purification, fill-finish, and release testing. SK pharmteco provides these across AAV, lentiviral, and adenoviral programs, with flexible engagement models depending on program stage and scope.

Viral vector process development focuses on optimizing yield, quality, and purity while building a process that meets regulatory expectations at scale. SK pharmteco supports this through platform-based approaches and custom development, with decisions on method selection driven by the vector modality, target indication, and clinical timeline.