Biosimilars

Transforming Life Towards Better Living

Jodas Expoim is a well-integrated research-driven biopharmaceutical manufacturing company, developing intellectual property through technology acquisitions, collaborative networking, and vibrant in-house R&D programs, also has robust research and development pipeline for biosimilars with platform-driven technology and leading manufacturing capabilities to manufacture and commercialize innovative products related mainly to immuno-oncology and autoimmune-related disorders.

Our Bio-technical department consist of a young, dynamic multidisciplinary team with Biotechnology, Microbiology, Biochemistry, and Bio-chemical engineering background with expertise in Biosimilars development, manufacturing, and commercialization backed by visionary leadership. We intend to develop effective biosimilars monoclonal antibodies and other recombinant biotherapeutics to meet the utmost medical needs of the common man.

Established in Biotech Park Phase III in Hyderabad, India, in 2020, Jodas Expoim is committed to providing high-quality biologics that are accessible and cost-effective for patients globally. Spread over 20,000 SQM, our state-of-the-art facility possesses advanced capabilities such as development, manufacturing, pre-clinical and clinical programs for biotech products. A cGMP facility for cell culture-based biotherapeutics, both Drug Substances and Drug Products.

Innovation and Development

R&D Initiatives

Our R&D Centre is dedicated to the development of biopharmaceuticals and aims to prevent and treat life-threatening diseases around the world.
Our infrastructure is equipped to conduct research in genetic engineering, molecular biology, genomics, animal cell culture, fermentation, purification, formulation, serology, and analytical testing. It supports the different stages of product development, from formulation to commercialization.
Our research activities focus on developing preventive and therapeutic biopharmaceuticals, including therapeutic proteins, growth factors, hormones, and monoclonal antibodies for infectious and lifestyle-related diseases.
Located at Biotech Park Phase III, Hyderabad, our R&D Centre spans over 500 square metres and is equipped with all the modern facilities required for the development of recombinant biotherapeutics.

R&D Infrastructure

The R&D center having well classified laboratories to handle different stages of development of Biotherapeutics –

Molecular Biology lab
Upstream process development and scale up lab
Downstream process development and scale up lab
Analytical method development lab
Bio Assay development lab

Major Equipment available to support the process development, optimization, scale up and validation

Eppendorf Bioreactor	TFF systems
Biorad RT-PCR	Waters HPLC with UV & FL detectors and UPLC
Stability chambers	Bio profile analyzer
Lyophilizer	UV-Visible spectrophotometer
Biorad Electrophoresis and Western blot apparatus	Biosafety Cabinet (BSL II)
Multimode Spectrophotometer with fluorescence detector	CE-SDS & CE-IEF
AKTA Pure and AKTA Pilot Chromatography systems

R&D Capabilities

Clone development with proven platform technology.
Batch, fed-batch, and perfusion strategies for biosimilars products
Downstream Process development with modern chromatography systems, Ultrafiltration-Diafiltration systems and Lyophilizer
Process and Product characterization
Process Scale-up and tech transfer to cGMP manufacturing plant
Formulation development
Analytical method development, qualification and validation
Bioassays development qualification and validation
Drug Substance and drug product stability studies
Product characterization

Our Pipeline of Biosimilars

We are advancing a portfolio of seven biosimilar candidates developed using recombinant DNA technology in CHO (Chinese Hamster Ovary) cell lines. Spanning process development through preclinical stages, the pipeline is focused on cytokines, growth factors, and monoclonal antibodies. The following candidates are at advanced stages of development:

1. Pertuzumab – For treatment of Breast Cancer.

2. Pembrolizumab and Nivolumab – PD-1 antagonists.

3. Atezolizumab – PD-L1 antagonists.

Our Manufacturing Capabilities

Manufacturing of cell culture based biotherapeutics under cGMP conditions, both Drug Substances and Drug Products
The manufacturing facility is built to meet the EU-GMP and USFDA regulatory requirements
The manufacturing facility is spread over 1,800 SQM and located at Biotech Park Phase III in Hyderabad, India
Dedicated State of the art cGMP facility with all modern equipment to run the manufacturing process of biotherapeutics in a seamless manner
The finished product in pre-filled Syringes and Vials
State of the art QC lab for release test of drug substances and drug products
Superior cold chain system for maximum care in storage and supply of products
Well establish Quality Management System (QMS) at various levels

Manufacturing Infrastructure

Bioreactor – Trains of 10L, 100L, 500L and 1000L for seed preparation to production for clinical trial requirement and commercial manufacturing of bulk drugs
Integrated Downstream set up with modern chromatography systems, depth Filtration unit, TFF and lyophilizer for purification and production of drug substances
Fill-Finish Facility for liquid formulation in Pre-filled Syringes and Vials
Fill-Finish Facility for Lyophilized formulation in Vials
Dedicated utilities: HVAC, Water systems-PW, WFI, PSG and compressed air, etc.
In process testing Labs and Warehouse