IBPL is India’s 1st first and only EMEA approved cGMP manufacturing facility for microbial and mammalian cell derived biologics. Our manufacturing services include production of recombinant proteins under cGMP conditions. We also offer GMP cell banking services.
The manufacturing facility is designed to comply EU as well as USFDA requirements. It houses independent production suites for microbial and mammalian cell-derived product manufacturing. The facility has ISO 7 to 9 clean rooms for supporting all the manufacturing activities.
IBPL is setting up a facility for Monoclonal antibodies (mAbs) with capacity up to 5000 L production and is expected to be operational by 2011.
Fill finish facility has capacity for aseptic fill finish and formulation of liquid (PFS & Vial) and lyophilized products in vials. Pre-Filled Syringe & Vial lines have capacity to delivering up to 18,000 units per shift.
A fully automated lyophilizer will be operational from January 2009 with capacity of producing 11,000 vials/ cycle.
Contact:
| Milan Doshi | Asst General Manager, Business Development |
IBPL has a dedicated, fully integrated R&D laboratory for developing biologics using recombinant technology. IBPL offers R&D services for bioprocess development, analytical method development, microbial cell banking & testing, method validation, formulation development, stability studies, product & process characterization. We have research experience in development of 5 E coli based, 3 CHO based processes and 2 PEGylated products and have capabilities in bioprocess development for intracellular, extra cellular and PEGylated proteins.
Our bioprocess development services include upstream and downstream process development for E. coli and CHO derived proteins. Our expertise lies in intracellular as well as extra cellular protein development from microbial culture and processes using adherent and suspension culture from CHO cells.
We also offer a wide range of analytical services for lot release, stability and in-process testing. Our analytical services also include N-terminal sequencing, CZE, CIEF, complete sequencing and Circular Dichroism. We also carry out analytical method validation as per ICH guidelines.
Contact:
| Milan Doshi | Asst General Manager, Business Development |
| Milan Doshi | Asst General Manager, Business Development |
Intas Biopharmaceuticals Limited (IBPL) and European pharmaceutical major Kwizda Pharma GmbH has jointly completed Phase I clinical trial study of NEUKINE®, biosimilar form of recombinant GCSF (2 Nov 2009)
Intas Biopharmaceuticals Limited (IBPL) and European pharmaceutical major Kwizda Pharma GmbH has jointly completed Phase I clinical trial study of NEUKINE®, biosimilar form of recombinant GCSF.
Intas Biopharma to pump in Rs 160 cr for dedicated facility for Monoclonal Antibodies (MAbs) (2 Nov 2009)
Ahmedabad-based Intas Biopharmaceuticals today said it has signed an MoU with the Gujarat government for setting up a Rs 160 crore facility dedicated to Monoclonal Antibodies (MAbs) at Sanand in Gujarat.
A leading Indian Biopharmaceutical company, Intas Pharmaceutical- Biotech division, has signed a Contract Research and Contract Manufacturing Agreement with a European company (1 Jun 2005)
The scope of the agreement covers process development and long term supply of a novel recombinant protein for clinical and commercial use.
IBPL is an integrated biopharmaceutical company with in house facility for development, manufacturing of bulk and finished formulation. The facility is GMP certified from Europe, South-Africa, GCC to name a few. With Peg GCSF, GCSF, EPO and IFN commercialized, business alliances in 78 countries and seven more biosimilar molecules under development (including Mabs and fusion proteins), IBPL is on the path to become Global Biopharmaceutical Company. Knowledge, Quality, Speed and innovative business models are driving force of IBPL. It is scouting for business partners for its Products. IBPL provides CRAMS and clinical trial services in biologics with its sister concerns.
Intas Biopharmaceuticals (IBPL) made a strategic entry into the biotechnology arena in 2001 via the establishment of Indus Biotherapeutics Ltd.; a dedicated biotech research company, in Ahmedabad INDIA.
Indus focuses on the development of recombinant protein-based biotherapeutics for human use. The focus is on developing commercial-scale technology in a timely and cost effective way. Our expertise lies in recombinant strain development, process and product development, development of analytical methods, bio-chemical immunological analysis, process validation and scale-up.
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