Advanced Biomanufacturing

Shilpa Biologicals has innovated unique platforms positioned to provide business value to customers worldwide

Drug Substance Manufacturing Services:

• GMP Cell Banking (Master, Working Cell Banks Preparation & Testing).
• Scale-up/Engineering Batches (10L to 2000L).
• Clinical and Commercial Manufacturing (50L to 2000L).
• Mammalian & Microbial Culture Dedicated Suites.
• Single Use & Conventional Stainless Steel (SS) Platforms.
• Fed Batch & Perfusion Mode Processes.
• Types of Products: Monoclonal Antibodies, Fusion Proteins, Novel Biologic Products, and Other Microbial & Cell Culture-Based Recombinant Proteins.
• Comprehensive Analytical & Microbiological Testing Support.

Mammalian Drug Substance (DS) manufacturing:

Upto 2000 Sqm drug substance preparation area consists of two independent streams, with Single Use bioreactors having individual seed train, subsequent DSP and cold rooms for process intermediates storage.

Upstream - 1000L, 200L, 50L, 20/50 RM bioreactors in stream 1.

2000L, 200L, 50L, 20/50 RM bioreactors in stream 2.

Harvest – Clarification by depth filtration, holder capacity 9.6m2, in both streams.

Downstream – Multiple chromatography with the capacity 1200 ml/min, 60l/Hr, 600l/Hr and TFF with holder capacity about 0.5m2, 5m2; pre-and post-viral segregation in both streams.

State-of-the-art equipment with data management system and 21 CFR part 11 compliance.

Designed for purifying high titre cultures.

Microbial Drug Substance (DS) manufacturing:

Upto 1200 Sqm drug substance preparation area with SS Fermenters. individual seed train, subsequent DSP.

Upstream - 2 trains with 1000 L, 200L, 20L SS fermenters.

Harvest – Clarification by continues centrifugation with 1000LPH capacity, hollow fibre filtration with 15m2 capacity.

Downstream – Multiple chromatography with 2000l/Hr capacity and TFF with holder capacity about 0.5m2, 5m2& 10m2.

State-of-the-art equipment with data management system and 21 CFR part 11 compliance.

Designed for purifying high titre cultures.

Process validation.

Cleaning validation.

Drug Product (DP) Manufacturing:

State of the art 3 independent fill finish suites with automated filling lines where “Ready to fill / Ready to sterilize” primary packing materials can be used.

Facility is available for secondary packaging and visual inspection before releasing prefilled syringes / vials for clinical or commercial distribution.

Filling lines& capabilities:

Isolator based RTU combi line from Snowbell with 40 parts / min filling capacity, multi - format - Vials and PFS.

RTU combi line from AST with 20 parts / min filling capacity, multi - format - Vials and PFS.

RTS vial line from NKP with 300 parts /min filling capacity, Vials filling 2mL to 100mL.

Packing capabilities:

PFSs packing:

PFS Plunger rod assembly & labelling machine with 80 units / min packing capacity.

PFS / vial blister packing machine with 80 units / min packing capacity.

Vial Packing Machines:

Stricker labelling machine: 130 units / min

Auto cartonator: 120 units / min

Checkweigher: 120 units / min

Common Machines for Serialization:

Online serialization & tamper proof evident machine (UTOS 300-T) & Aggregation system (Utoprins 202 AGCI).

Warehousing capabilities:

Facilities are supported by comprehensive storage capacity of RM and finished product.

2 individual warehouse facilities are available with totalling to greater then 1200 Sqm.

• Walk-in freezer of -20°C with 150 KL capacity to hold up to 600,000 vials.
• Walk-in freezer of -20°C with 19,200 L capacity to hold 100,000 vials.
• Walk-in cold room of 2-8°C with 93 KL capacity to hold up to 400,000 vials.
• Walk-in cold room of 2-8°C with 26.2 KL capacity to store DS.
• Walk-in cold rooms (2 Nos) of 2-8°C with 25.2 KL capacity to store RM.
• Walk-in cold rooms (2 Nos) of 2-8°C with 9.6 KL capacity to store RM quarantine & recall.
• Walk-in cold rooms (2 Nos) of 2-8°C with 17.0 KL capacity to store intermediate packed products at the packing area.