Manufacturing

The Brooklyn Park site houses over 119,000 SF of biologics manufacturing area containing 22,000 L of mammalian cell culture bioreactor capacity. There are two segregated suites, one with two 1,000 L production bioreactors, and another with two 10,000 L production bioreactors. These two trains can support simultaneous multi-product manufacturing. The 1,000 Land 10,000 L bioreactors are also flexible and can be operated at 400 L and 5,000 L, respectively.

Highlights of the Upstream Processing Area:

  • Experienced manufacturing capabilities with high producing NS0 and CHO cell lines
  • Fed batch cell culture process
  • Potentially 40 runs of both 1,000 L and 10,000 L scale per year
  • Cell banking (master cell bank & working cell bank)

Highlights of the Downstream Processing Area:

  • Capacity for purification of mAbs with titers up to 4.0 g/L
  • Anion/Cation exchange chromatography
  • Ultrafiltration / Diafiltration
  • High purification yields (60-75%)

Highlights of the Media and Buffer Preparation Areas:

  • Cell culture basal media is prepared in Media Preparation and transferred to bioreactors prior to inoculation.
  • Cell culture feed medias (up to four simultaneous) are prepared in Media Preparation and transferred to Media Hold or disposable bag systems for storage until required by the bioreactors.
  • Buffers are prepared in the Buffer Prep area and transferred to Buffer Hold or disposable bags systems for storage until requires by the downstream systems.

Equipment technologies for the main manufacturing area include:

Equipment ClassDescriptionRemarks
Inoculum PreparationShake Flasks and Wave Bags up to 20-L scale
Seed BioreactorsSmall Scale (SS) Train - 100 L; Large Scale (LS) Train - 100 L to 300 L to 1,000 L
Production BioreactorsSS Train - two (2) x 1,000 L; LS Train - two (2) x 10,000 L
SS and LS harvest volumes down to 400 L and 5,000 L, respectively.
Media PreparationTwo (2) Preparation Vessels / 1000 - 6000 LPreparation volumes down to 250 L in the fixed vessels.
Media StorageTwelve (12) Hold Vessels (four not commissioned) plus bag capability/300 -5,000 L
Up to four (4) simultaneous media feeds per production bioreactor.
CentrifugationOne (1) / SS Disk Stack / 1,200 LPH;
One (1) / LS Disk Stack / 5,000 LPH
Depth FiltrationTwo (2) / SS Millipore Millistak+ Stacked Disk / 2 high x 16 inch;
Two (2) / SS Code 7 / 1 x 30 inch (0.22 mm);
Two (2) / LS Millipore Millistak+ Pod Filter / 4 x 11 m2 racks;
Two (2) / LS Code 7 / 6 x 30 inch (0.22 mm)
ChromatographyOne (1) / SS Affinity / 30 cm ID x 5 - 30 cm Column;
One (1) / SS Anion Exchange / 30 cm ID x 10 - 40 cm Column;
One (1) / SS Cation Exchange / 30 cm ID x 20 - 40 cm Column;
One (1) / LS Affinity / 1 m ID x 5 - 30 cm Column;
One (1) / LS Anion Exchange / 1 m ID x 10 - 40 cm Column;
One (1) / LS Cation Exchange / 1 m x 20 - 40 cm Column
Systems designed for cycling.
Viral Inactivation and FiltrationOne (1) / SS Code 7/ 3 x 10 inch (NFP or 0.22mm) and/or
One (1) / SS Disposable Station (Asahi Kasei Planova);
One (1) / LS Code 7/ 6 x 30 inch (NFP) or Four (4) Nominal Disposable Stations (Asahi Kasei Planova);
One (1) / LS Code 7 / 3 x 30 inch (0.22 mm)
Ultrafiltration/
Diafiltration
One (1) / SS Plate and Frame / 1 - 5 m2;
One (1) / SS Plate and Frame / 5 - 15 m2;
One (1) / LS Plate and Frame / 10 - 40 m2;
One (1) / LS Plate and Frame / 40 - 120 m2
Buffer PreparationFive (5) preparation vessels / 200 - 10,000 L
Buffer StorageTwenty (20) Hold Vessels plus bag capability / 20 - 10,000 L