Products

Vertically Integrated Biologics Company

Overview

As a vertically integrated biopharmaceutical company based in Taipei, Taiwan and San Diego, California, Tanvex BioPharma has capabilities spanning product development, manufacturing, sales and distribution. The company has proven expertise in all relevant areas:

Strain and cell-line development in both microbial and mammalian systems

Cell culture

Protein purification

Process scale-up

Drug substance and product manufacturing

Warehousing, sales and distribution

Product Development

Strain and Cell Line Development

Strain and cell line construction takes place in our Research Lab in Taipei, Taiwan. Using expression vectors developed in house, we employ high throughput robotic screens to select candidate clones or cell-lines capable of high-yield production of proteins sharing critical quality attributes with referenced products. Additionally, we optimize culture media and growth conditions with the same objectives in mind.

Our cell line development is distinguished by:

Well characterized mammalian and microbial expression of host strains/cells

Highly efficient expression vector system

High-throughput screening and selection for high productivity cell lines with desired product quality profiles

GMP compliance with Master Cell Bank (MCB) and Working Cell Bank (WCB) productions

Cell Culture and Fermentation

Master cell selection and “seed” development also take place in our Taiwan-based facilities. We develop robust, high-quality, cost-effective, and commercially viable cell culture processes for both mammalian and microbial systems, covering cell banking process definition, scale-up, and generation of toxicology material. These cells are then transferred to our U.S. facility for further development.

Process and Drug Product Development

Process and drug product development are carried out in our San Diego, California facility. Clones and cell-lines received from our Taiwan operation are further optimized for growth, stability, and expression level as well as the physical and biologic properties that are most similar to the reference products.

Our well-developed purification processes support production of material for all early-stage clinical trials as well as commercially viable end product. Our experienced staff defines and develops formulation and delivery systems that maximize drug substance and drug product stability.

Manufacturing

Our multi-product manufacturing facility meets stringent global regulatory requirements. Supporting both microbial and mammalian cell line development, process development, and manufacturing, we employ the latest technologies for both upstream and downstream processing to obtain speed, flexibility, and high quality products at low cost.

We deploy a wide range of cGMP biologics manufacturing capabilities. Microbial Fermentation and Mammalian Cell Culture Suites are equipped with state-of-the-art bioreactors. Our downstream purification train uses efficient automated technologies for chromatography and filtration. Our aseptic fill/finish area is segregated within the facility from the Cell Culture and Purification Suites, and equipped with individual fill suites and dedicated gowning areas. We can accommodate product delivery in vials or pre-filled syringes, with market-ready clinical labeling.

Built with growth and expansion in mind, we have invested in space and leading edge technology and equipment to ensure a fast ramp to commercialization and reduced time to market.

Product Pipeline

Copyright © 2016 Tanvex BioPharma Inc. All rights reserved

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