Large Scale Plant Porri o

Large Scale Plant Porri o

Single Use Commercial Scale Facility

About the plant

Manufacturing

Upstream

Cell and virus cultivation

Culture process in wave bioreactors

Single-use bioreactors

•2 x 50 L

•3 x 200 L

•3 x 2000 L

Blending mixer

•Single-use tank • 1 x 1500 L

Media preparation

Single-use mixers

•2 x 3000 L

•2 x 2500 L

•1 x 1000 L

•2 x 650 L

•1 x 200 L

Downstream and purification

Single-use mixers

•1 x 1500 L

•1 x 650 L

•1 x 500 L

 

Fill & Finish

Formulation and blending

•1 x 350 L single-use tanks

•4 x 600 L stainless-steel tanks

•1 x 3000 L single-use tank

•4 x 6000 L stainless-steel tanks

2 filling lines: DARA machines

Capacity of each line based on vial size

•Size 2R: 12 000 vials/hour

•Size 10R: 10 800 vials/hour

•Size 20R: 9600 vials/hour

Automatic visual inspection

•2 x OPTREL machines Storage: (+2 - +8°C), (- 30°C) and (- 80°C)

Storage: (+2 - +8°C), (- 30°C) and (- 80°C)

Combination of inhouse and subcontracted capacity for more storage.

2 double-door autoclaves connecting the washing and depyrogenation tunnels room with each filling room

---

Certifications

• ISO
• EMA (EU GMP)
• World Health Organization (GMP / HACCP)

---

Activity

• Abs (Antibodies), Peptide, protein, hormone & enzyme, Vaccines, BIOLOGICS manufacturing

---

Features

• Uses: Investigational, Commercial (Phase IV), Phase III, Human
• Toxicity (OEB classification):
• DEA: N/A
• BSL: 1, 2
• Therapeutic areas: (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system
• Markets: EMA (EU)

---

Batch Size / Reactor

• Medium, Large, Batch, Fed-batch, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, 2000 - 5000 L

---

Services

• Regulatory services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Storage

---