The facility is being planned for Inactivated Polio Vaccines
Production Capacity shall be 20 Million dosages per annum.
Fermentation Capacity: 2.0KL
Controlled and restricted authorized access to the facility and storage areas
Designed as per BSL-3 and GAP III requirement.
Live areas room pressures are negative with respect to atmosphere.
Dedicated Air Handling Units for Live and Non-Live areas with heaters in Exhaust and HEPA filters in return air.
Decontamination procedures for the material and containers used in live manufacturing areas.
Purified water and WFI pressurized circulation systems.
Liquid waste from live areas will be directed to kill tank for further treatment
Stelis Biopharma Pvt Ltd - Bengaluru, India
Snapshot
COVID-19 Vaccine Manufacturing Facility.
Built up Area = 12,000 sq.m
Project Brief
The facility is being planned for COVID-19 Vaccine.
Production Capacity will be 210 Million dosages / annum.
Fermentation Capacity: 2.0 KL – 20 Nos.
Controlled and restricted authorized access to the facility and storage areas.
Designed as per BSL-2 requirement.
Negative Pressure (Sink) for live areas intended for viral activities.
Decontamination procedures for the material and containers used in live manufacturing areas.
Cold WFI and Hot WFI pressurized circulation systems.
Liquid waste from live areas will be directed to kill tank for further treatment.
Biological E Ltd - Hyderabad, India
Snapshot
Antigen (COVID) Vaccine Facility
Built up Area = 3,736 Sq.m
Project Brief
The facility is being planned for Covid-19 Antigen Vaccine
Production Capacity shall be 50 Million dosages per annum
Fermentation Capacity: 3.5KL
Controlled and restricted authorized access to the facility and storage areas.
Laminar Air Flow Units for Product Protection.
Negative Pressure (Sink) for live areas intended for viral activities.
Dedicated Air Handling Units for Live and Non-Live areas.
Decontamination procedures (Steam sterilization) for the material and containers used in live manufacturing areas.
Purified water and WFI pressurized circulation systems.
Liquid waste from live areas will be directed to kill tank for further treatment.
Biological-E Ltd - Hyderabad, India
Snapshot
Injectables Formulation Facility
Built up Area = 5,900 sq.m.
Project Brief
Fill and Finish Plant to manufacture products of following dosage forms.
Lyophilized (Freeze Dried) Injectable in Vials.
Liquid Injectable in Vials.
Liquid Injectable in Pre-Filled Syringes.
Filling Line with 300 Vials/min.
Facility design comply to USFDA and EU requirements.
Wockhardt Ltd - Aurangabad, India
Snapshot
Project D - Biosimilar API Manufacturing Facility
Built up Area = 2,150 sq.m.
Project Brief
The production block has two Bioreactor (Fermenter) of 20 KL capacity each with seed fermenter train and harvester. Phase II was planned for downstream processing.
This facility houses manufacturing section, personnel gowning areas, technical area for AHUs and routing of services.
In addition to Production Block, Utility block was expanded to house additional chiller and air compressor. The plant was designed with a prime emphasis on product, personal & environmental safety.
Layout was prepared to allow unidirectional movement of material and personnel and minimize potential mix-ups. The main manufacturing areas were maintained at negative pressure with respect to peripheral socially clean corridor.
Biological E Ltd - Hyderabad, India
Snapshot
MR Vaccine Manufacturing Facility
Built up Area = 4000 sq.m.
Project Brief
Six modules for vaccine based on various technologies.
The first module to manufacture MR (Measles – Rubella) vaccine based on chicken embryo fibroblast (CEF) cell culture and cell substrate (human diploid cells, MRC-5 cells) respectively on campaign basis.
The facility is designed as cGMP compliant and of BSL 2 containment category.
MSN Laboratories Pvt Ltd - Hyderabad, India
Snapshot
mAb’s Microbial and Fungal Fermentation Manufacturing Facility
Built up Area = 400 sq.m.
Project Brief
The New manufacturing block is developed to house following sections:
5 KL microbial facility
Plan to use conventional cultures
Provision for using Recombinant cultures
Area contains Microbial Lab (Cell propagation), Seed and Fermentation area, Cell Lysis / Filtration area (Harvest), Extraction in solvent , In process QC, Material Day store (with Dispensing), Personnel entry and exit, Bio kill system, Central Warehouse, Utility Block, ETP, Solvent store area
Fermenta Biotech - Dahej, India
Snapshot
Vitamin D3 Manufacturing Facility
Built up Area = 6,226 sq.m.
Project Brief
Project in SEZ Area.
Greenfield Facility.
Fermentation and API Facility.
Phase Wise Implementation.
First Phase Completed in 12 Months.
Second Phase completed in 9 months.
Abode Biotech Pvt Ltd - Hyderabad, India
Snapshot
Human Probiotic Facility
Built up Area = 3,000 sq.m.
Design-Build Project
Project Brief
Phase 1.
Design & Build of Pilot Scale Facility.
The facility consists of 6*2 KL Fermenters and up stream processing equipment such as centrifuge, Blender and spray dyer.
Phase 2.
The manufacturing block consists of Human Probiotic facility with 20KL fermentation capacity.
The main block consists of Manufacturing areas, warehouse, Change rooms & Service areas.
Tex Biosciences Pvt Ltd - Chennai, India
Snapshot
Enzyme Facility for Animal Feed
Built up Area = 3,000 sq.m.
Project Brief
The facility was designed to meet GMP norms applicable for manufacturing animal feed enzymes.
The facility consists of two manufacturing suit each having two fermenters of 10 KL capacity. One suit was dedicated for bacterial fermentation and other for fungal fermentation.
The downstream processing equipment consist of centrifuge, reverse osmosis, and Spray drying and blending facility.
The utility block consists of air compressor, chiller and cooling tower.
Lazuline Biotech Pvt Ltd - Hyderabad, India
Snapshot
Biotech API Facility
Built up Area = 4,700 sq.m
Project Brief
This green field Biotech API facility of Antigens, Industrial Enzymes & new biotech facility for API products.
This facility shall be built as per the cGMP and Good Engineering practice and upon completion, shall follow Indian Schedule M, WHO, USFDA and EUGMP.
The main block consists of Manufacturing areas, warehouse, Change rooms & Service areas. Manufacturing areas planned for 2 X 5KL Fermenters, Gowning areas, warehouse & supporting Service areas.
Stelis Biopharma Pvt Ltd - Bengaluru, India
Snapshot
MABS Manufacturing Facility.
Built up Area = 12,000 sq.m
Project Brief
The facility is being planned for Monoclonal Antibodies
Four Suits with Each Suit Capacity: 2KL X 2 No’s fermentation capacity
Central warehouse with mobile racking system Capacity: 600 Tons'
Controlled and restricted authorized access to the facility and storage areas
Laminar Air Flow Units for Product Protection.
Process room pressures are negative with respect to Corridors to avoid cross contamination
Dedicated Air Handling Units for each process area
Contamination procedures, Single use Bioreactor for each batch.
Liquid waste from live areas will be directed to kill tank for further treatment.
Gen Biosciences Pvt Ltd - Hyderabad, India
Snapshot
Multiproduct Vaccine Manufacturing Facility
Built up Area = 65,000 sq.m
Project Brief
The facility is being planned as multiproduct Vaccine facility.
Production Capacity will be around 290 Million dosages per annum.Approved by GMP EU PIC/S & GDP.
Fermentation Capacity: 6.0KL – Total of 9 suites for Drug Substance.
Controlled and restricted authorized access to the facility and storage areas.
Drug Substance facility is designed for handling BSL -3 products.
Negative Pressure (Sink) for live areas intended for viral activities.
Once through Air Handling Units for Live with UV lamp in in exhaust for BSL -3 area.
Decontamination procedures for the material and containers used for BSL-3 area.
Bio decontamination system for Liquid waste.
Liquid waste from live areas will be directed to kill tank for further treatment.
.png)
.png)