Clonz Biotech Pvt. Ltd
Clonz Biotech was founded in 2010 by an experienced team of recognized leaders in biosimilar research and manufacturing. We operate from Genome Valley, Hyderabad, India to exclusively focus on developing the biosimilar therapeutic monoclonal antibodies (MABs). Developing therapeutic monoclonal antibodies (MABs) are at the heart of our business which is heavily people / knowledge dependent. We are very focused on the knowledge pool and people perspective that is central to both increasing our understanding on MABs and building accessible biologics for a wider global market. The manufacture of MABs is highly complex, requiring exceptional experience and tenacity. At Clonz we are specialists in bioengineering and creating biosimilars that improve accessibility for patients.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Research
- Market Focus:
- Globally (various continents)
- Year Founded:
- 2010
About Us
To achieve this we employ in house clone/product development with complete understanding and control over processes to ensure robust manufacturing.
As a result of our commitment to helping patients lives, we develop products, processes that give excellent yields, purity and are remarkably efficient compared to some larger less specifically MABs focussed organizations.
Efficiency/speed of mass production is essential to the strategy here at Clonz.
Clonz has moved into its new facilities which will further leverage its core competency in mammalian cell line development bringing biosimilars to market in several disease therapeutic areas.
The last decade one might say has been the preparation for this coming decade which will prove to be very exciting for Clonz but also our ambition to define ourselves as leaders in the accessible biologics area.
Vision & Values
Our Vision
Give greater accessibility to life-improving oncology and immunology biologics by building, engaging and supplying like-minded partners globally.
Our Mission
Strive to be the most knowledgeable and experienced in the MABs area regarding engineering and manufacturing of biosimilars and biobetters. Strengthen our scientific reputation in key therapeutic areas while improving productivity, remaining faithful to honest sustainable ethical compliant trading.
Our Promise
All our partners, employees and suppliers, please know we are committed to equal opportunities and striving to improve people’s lives. Transparency and fair trading while always defending any shared IP for our partners underpins our values as a business.
Research & Development
Clonz Biotech offers mammalian and microbial pharmaceutical R&D services with cGMP-enabling processes. Services include mammalian cell line development, microbial strain development through a well planned genetic engineering for efficient process advantages. Key areas include research cell bank production, process development, process optimization using statistical Design-of-Experiments (DoE), technology transfer, scaled-down model development and process characterization using a QbD framework.
Clonz Bio R&D uses the latest equipment available. Most of the equipment is under two years old, even though as a company we were founded over ten years ago.
The R&D facility has the following key departments:
- Molecular biology
- Fermentation / Cell culture
- Bioassay
- Purification
- QA / QC
Manufacturing
Clonz offers a modern manufacturing capability spread across a 40,000 square feet mammalian facility, based in Genome Valley, Hyderabad. It delivers a fully customised manufacturing solution to suit the requirements of both captive and external clients. We provide cGMP manufacturing, process development and manufacturing support.
Our manufacturing services include:
- cGMP mammalian manufacturing up to 2,000L
- cGMP mammalian cell banking
- Enables cGMP production in cell culture suites from 50L to 2000L scale
Our fully integrated capability features process development, analytical labs and independent warehouse.
Downstream purification is carried out in purification suites with different capacities of CLARIFICATION, TFF, chromatography systems and columns.
Vial filling features with liquid, lyophilized powder and pre-filled syringes.
The site is purpose-built for multi-product cGMP production of monoclonal antibodies (MABs).
Technologies
Products are developed on chinese hamster overy (CHO) based mammalian platform using recombinant DNA technology.
Innovative process developed in-house with the proprietary DNA Vectors having novel genetic elements in-licensed from a Swiss company enable scientific rigor with speed to develop highly-comparable biosimilars.
Having developed the clone in-house with well understood characteristics and intricacies of the host system, it’s one of the great strengths enabling Clonz to have the complete control over the manufacturing process in the future.
EHS & Sustainability
EHS is at the forefront of minds and policy every day.
We strive every day to improve our processes to maintain the safety and well being of our staff.
Our new labs in Genome valley have just come into operation featuring the latest safety equipment and procedures recommended by global pharma.
We are also building a state of the art manufacturing facility at the Genome valley on the outskirts of Hyderabad. This new facility will adhere to the most stringent EHS requirements demanded by a global pharma community.
More details on the specifics of the environmental controls and checks put in place at our new facility will be published as the facility is built in the coming months.
Clonz is an equal opportunities employee, employing highly motivated staff who share our passion for MABs.