Biotechnology & Biosimilars
Facilities integrate bioreactors, seed-train suites, sterile utilities, CIP/SIP, single-use systems, UF/DF skids, and contamination-controlled Grade A/B/C/D environments. Designed for fermentation, purification, cold-chain handling, and biosafety-aligned flows for high-value biologics.
Facilities to produce
- Vaccines, enzymes
- mAbs, recombinant proteins
- Cell‑culture products, biosimilars
How PPlus engineers biotech facilities
- Process‑driven layouts for fermentation, purification, and fill‑finish
- Grade A/B/C/D cleanrooms with pressure cascades
- CIP/SIP, sterile air, WFI/PW, and single‑use system integration
- Biosafety‑aligned HVAC with validated exhaust and EM systems
Regulatory Compliance
cGMP, ISO 14644, US FDA-CDER, EMA (European Medicines Agency), WHO – TRS & GMP Guidelines, Indian CDSCO, ICH, biosafety guidelines (BSL-aligned), EM & validation
Why PPlus?
PPlus combines deep bioprocess understanding, sterile utility engineering, biosafety design, and global regulatory expertise, delivering world‑class biotech facilities.
Emerging & Regulated Industries
FAQs
Can PPlus design single‑use bioreactor facilities?
Yes, integrated with sterile utilities and contamination‑controlled flows.
How does PPlus ensure biosafety?
Through BSL‑aligned zoning, validated exhaust, and controlled airflow.