Escherichia coli
Highly efficient expression of soluble proteins, inclusion bodies, and non-glycosylated antibody fragments using IPTG-inducible or constitutive promoter systems.
High-density microbial fermentation advancing recombinant biopharmaceuticals from strain engineering to commercial drug substance supply.
At Shilpa Biologicals, we deliver complete microbial fermentation contract development and manufacturing organization (CDMO) services tailored for pharmaceutical and biotechnology partners worldwide. Operating out of our modern cGMP biomanufacturing infrastructure in Dharwad, Karnataka, India, Shilpa Biologicals provides end-to-end, backward-integrated solutions for microbial biopharmaceuticals.
Whether your candidate requires early-stage strain development, high-density fermentation optimization, complex protein refolding, or large-scale microbial biomanufacturing, our team leverages bacterial and yeast platforms to ensure high yields, purity, and global regulatory compliance. We accelerate non-glycosylated proteins, enzymes and antibody fragments from gene to market.
Developing cost-effective microbial biologics demands scalable host platforms, high cell density fermentation, and tailored refolding strategies. Shilpa Biologicals integrates strain development through commercial bulk microbial manufacturing within dedicated containment suites.
Selecting the optimal expression host is critical for volumetric productivity and correct protein folding.
Bacterial and yeast platforms, plus custom strains built for your molecule.
Highly efficient expression of soluble proteins, inclusion bodies, and non-glycosylated antibody fragments using IPTG-inducible or constitutive promoter systems.
Methylotrophic and budding yeast systems engineered for secretable proteins, disulfide-rich molecules, and post-translational processing without complex mammalian glycans.
Custom host engineering, vector construction, codon optimization, transformation, high-throughput clone screening, and Master/Working Cell Bank (MCB/WCB) creation under cGMP conditions.
From millilitre screening to production-scale fed-batch, on one data trail.
Media composition and induction screening utilizing Ambr® 15mL Micro Bioreactors, shake flasks, and 2L/10L glass fermenters.
Establishing operational design space through Quality by Design (QbD) principles to predict large-scale behavior.
Execution across Batch, Fed-Batch, and High-Density (HD) Fed-Batch processes with precise oxygen transfer (OTR), pH, temperature, and nutrient feed strategies.
Shilpa Biologicals provides robust microbial CDMO services backed by WHO-GMP standards and dedicated stainless steel fermenters.
Tight control over cell harvest, cell disruption, inclusion body recovery and downstream purification.
Construct design, transformation, high-expression clone screening, and cGMP Master/Working Cell Bank (MCB/WCB) production.
PurposeEstablishing a genetically stable microbial seed train.
Seed train expansion in 20L SS fermenters leading into 200L and 1000L SS fermenter trains.
PurposeAchieving high cell densities and high volumetric titers.
Continuous centrifugation (up to 1,000 LPH) and high-pressure homogenization for intracellular targets.
PurposeEfficient biomass recovery and complete cell lysis.
Inclusion body (IB) isolation, washing, solubilization, and oxidative refolding parameter optimization.
PurposeConverting inactive aggregates into biologically active native protein conformations.
High-throughput chromatography (up to 2,000 L/Hr capacity) and TFF systems (0.5–10 m²).
PurposeRemoving host cell proteins (HCP), nucleic acids, and endotoxins.
Final UF/DF formulation into bulk microbial biopharmaceuticals stored in walk-in cold environments.
PurposeEnsuring long-term product stability under controlled cold-chain conditions.
Converting inactive aggregates into biologically active native protein conformations.
Automated isolation protocols ensuring high purity of raw inclusion bodies prior to solubilization.
Multi-factor screening of redox pairs, chaotropic agents, pH, and temperature to achieve correct tertiary structure folding while preventing re-aggregation.
Removing host cell proteins (HCP), nucleic acids, and endotoxins.
Multi-column setups providing up to 2,000 L/Hr flow rates, utilizing Ion Exchange (IEX), Hydrophobic Interaction (HIC), Mixed-Mode, and Affinity chromatography.
Scalable Tangential Flow Filtration (TFF) assemblies with membrane holder capacities of 0.5 m², 5 m², and 10 m² for rapid concentration and buffer exchange.
Process execution backed by 21 CFR Part 11 compliant digital controls.
Our microbial CDMO services cater to a range of non-glycosylated and microbial-expressed target molecules:
High-yield production of therapeutic enzymes, human growth hormones, and insulin analogs using optimized E. coli or yeast expression strains.
Robust biomanufacturing workflows designed for cytokines, chemokines, and high-purity plasmid DNA (pDNA) required for gene therapy and mRNA vaccine manufacturing pipelines.
Engineered microbial systems for single-domain antibodies (VHH), nanobodies, and Fab fragments that do not require complex mammalian glycosylation patterning.
Up to 1,200 sqm of dedicated microbial drug substance processing space in Dharwad, India, separate from mammalian operations.
| Infrastructure parameter | Microbial DS technical specifications |
|---|---|
| Preparation area footprint | SpecificationUp to 1,200 Sqm dedicated microbial DS suite. |
| Fermenter infrastructure | SpecificationDual upstream trains equipped with 1000L, 200L and 20L Stainless Steel (SS) fermenters. |
| Harvest equipment | SpecificationContinuous centrifugation capacity up to 1,000 LPH; hollow fiber filtration capacity up to 15 m². |
| Downstream flow capacity | SpecificationChromatography systems rated up to 2,000 L/Hr capacity. |
| TFF holder capacities | SpecificationUltrafiltration/diafiltration setups at 0.5 m², 5 m², and 10 m². |
| Data integrity standards | Specification21 CFR Part 11 compliant automated data management systems. |
Bulk drug substance can be processed directly into automated fill-finish lines for vials and pre-filled syringes within isolator-protected suites.
Large-capacity cold chain to maintain product stability.
Shilpa Biologicals operates biomanufacturing facilities governed by an integrated Quality Management System (QMS). Our infrastructure operates under CDSCO regulations, holds WHO-GMP certification, and is engineered to maintain compliance with USFDA, EMA, ANVISA, and PIC/S standards.
Analytical Method Development (AMD) and Quality Control (QC) platforms ensure that Critical Quality Attributes (CQAs) are systematically controlled throughout fermentation and purification.
In-house analytical capabilities include RP-HPLC, SEC-HPLC, SDS-PAGE, residual host cell DNA (qPCR), host cell protein (HCP ELISA), residual endotoxin testing (LAL assay), and mass spectrometry.
Complete regulatory affairs assistance for IND and BLA submissions globally.
Shilpa Biologicals provides a backward-integrated microbial CDMO platform spanning strain development through commercial drug substance manufacturing. Featuring dual upstream trains with 1,000L stainless steel fermenters and 2,000 L/Hr downstream capacity within a 1,200 sqm suite, we deliver scalable batch and fed-batch processes.
Headquartered in Dharwad, India, we serve biopharmaceutical partners globally, backing our operations with WHO-GMP certification and strict USFDA/EMA compliance alignment to derisk regulatory pathways.
What partners ask before starting a microbial fermentation program with us. Can’t find your answer?
Talk to our teamShilpa Biologicals works with Escherichia coli, Pichia pastoris, Saccharomyces cerevisiae, and custom engineered bacterial or yeast strains tailored to target molecule expression.
Our microbial drug substance facility features dual upstream processing trains equipped with 20L, 200L, and 1000L Stainless Steel (SS) fermenters.
We specialize in inclusion body isolation, solubilization, and oxidative refolding optimization, establishing parameters that maximize native-state protein recovery.
Our downstream suites feature multi-column chromatography systems with flow rates up to 2,000 L/Hr, continuous centrifugation (1,000 LPH), and TFF assemblies up to 10 m² holder capacity.
Yes, bulk drug substance can be processed directly into our automated fill-finish lines for vials and Pre-Filled Syringes (PFS) within isolator-protected suites.
Accelerate your microbial fermentation project with an experienced CDMO partner. From strain engineering to commercial scale-up, our team delivers high-yield solutions.
Share the molecule, the expression host and the scale you are planning for. Our technical team will come back with what is possible on strain development, fermentation and downstream processing.
Shilpa Biologicals is a fully integrated microbial fermentation CDMO in India, providing end-to-end microbial biologics manufacturing services to pharmaceutical and biotechnology companies worldwide. Operating from a purpose-built biomanufacturing facility in Dharwad, Karnataka, Shilpa Biologicals offers one of the largest microbial fermentation capacities in India with 200,000 Liters of installed stainless-steel fermenter infrastructure. Our microbial CDMO services span strain engineering, upstream and downstream bioprocessing, drug substance production and integrated drug product fill-finish, supporting partners across the United States, European Union, Canada, Brazil, Japan and other regulated markets with the scale, compliance and technical capability that global programs demand.
A microbial fermentation CDMO is a contract development and manufacturing organization that specializes in developing and producing biopharmaceutical drug substances using microbial expression systems such as E. coli, Pichia pastoris, Saccharomyces cerevisiae and other microbial hosts. Microbial fermentation manufacturing is essential for producing a broad range of therapeutic biologics including recombinant proteins, industrial enzymes, peptide-based therapeutics, vaccine antigens and biosimilar intermediates that require high volumetric productivity, rapid growth cycles and cost-efficient scale-up. Shilpa Biologicals operates as a microbial CDMO in India, delivering these specialized microbial manufacturing capabilities to global innovators and established pharmaceutical companies who require cGMP microbial drug substance production backed by comprehensive analytical characterization and regulatory filing support.
India has emerged as a strategic global destination for microbial biopharmaceuticals manufacturing, and international pharmaceutical companies are increasingly partnering with Indian biologics CDMOs for microbial fermentation manufacturing for the following reasons:
Shilpa Biologicals is a subsidiary of Shilpa Medicare Limited, a publicly listed pharmaceutical company with over three decades of proven success in drug development, regulatory approvals and global supply across 50+ countries. This parentage provides Shilpa Biologicals with access to established quality management systems, deep regulatory expertise and robust operational infrastructure that underpin every microbial CDMO engagement. As the dedicated biologics arm of the Shilpa group, Shilpa Biologicals brings this legacy of pharmaceutical excellence to the microbial biopharmaceuticals space, combining heritage and innovation to serve global CDMO partners.
Shilpa Biologicals operates a purpose-built microbial biomanufacturing facility in Dharwad, India, featuring one of the largest installed microbial fermentation capacities among Indian biologics CDMOs. Core capabilities for microbial fermentation manufacturing include:
Shilpa Biologicals operates under an integrated Quality Management System (QMS) designed to meet the highest international regulatory standards for microbial biologics manufacturing. Our biomanufacturing facility maintains the following certifications and compliance alignments:
In-house analytical capabilities including HPLC, SDS-PAGE, mass spectrometry, endotoxin testing and microbial limit testing support comprehensive drug substance characterization at every stage of the microbial manufacturing process. Regulatory affairs teams at Shilpa Biologicals provide end-to-end support for IND and BLA dossier compilation, helping global partners navigate regulatory pathways across the US, EU, Brazil, Japan and other target markets.
For pharmaceutical and biotechnology companies seeking a reliable microbial CDMO partner in India with large-scale fermentation capacity and global regulatory alignment, Shilpa Biologicals delivers the technical depth, facility scale and quality infrastructure required to advance biologics programs from early development through commercial supply. Whether the requirement is microbial fermentation for biopharmaceutical production at clinical scale or full commercial microbial drug substance manufacturing, our integrated biomanufacturing platform in India is engineered to accelerate your path to global markets. Contact Shilpa Biologicals to discuss your microbial CDMO requirements.