• Gene modification and ​stable cell line
• Analytical/Assay Development
• Qualified QC Laboratory Services  
• Cell Line Storage Services
• Process Development / Production
• GMP Manufacturing
• Antibody Characterization

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Our Proprietary Vector Technology

• We can use our proprietary in house vector to develop and optimize the gene and create the stable cell at faster development cycle.
• ​We  can develop and optimize the gene and cell line to create stable clones for cell line banking.
• ​Our team can provide both mammalian and microbial expression system development for the drug candidate. ​​​​​

Experience in biopharmaceutical method development

• Practical experience with biologic drug product using various self developed assay 
• Work with our clients to ensure successful technology transfer, development, and validation of the method. 
• Follow regulatory guidelines for the stage appropriate testing of the product.​
• With systematic project management protocol to deliver and meet client requirement efficiently.

QC Testing 

We will work closely with our clients to ensure successful technology transfer, analytical and method development and validation are performed in compliance to relevant regulatory requirements. 

We uses standard pharmacopoeia (USP, EP, CP etc) and our equipments are qualified and strictly maintained under SOP.    We can provide subcontract testing service, both for drug characterisation during early drug development or for product release testing during preclinical and clinical drug manufacturing.   
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DNA/Protein Testing

• Protein / IgG Concentration
• ELIZA Test
• Sterility Test (BacTalert)
• Endoxotin
• Drug Potency and Functional Test
• Western Blot
• IEF
• HPLC
• Dry powder formulation testing

Cell Testing

• Cell Identification
• Viable Cell Count
• Mycoplasma
• Sterility Test (BacT Alert)
• ​Cell Stability

​Our tests is based on various international standard and pharmacopoeia, such as ICH guidelines, USP, EP, CP etc and is conducted under controlled environment and is reviewed by registered and qualified QC expert. 

Secure Cell Storage

• Our Cell Bank system contains automatic cryogenic control with local and remote monitoring system to provide reliable cell line storage condition. 
• The system also equip with backup utilities and ensure 24 x 7 operation without interruption.
• The facility is protected by in-house security and access control.
• Support by regular physical, biological and potency test to ensure product quality.
• Our in-house QC team can test for ID, absences of contamination and stability for storage with Certificate of Analysis. ​​​

Stability Testing

• Drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life.
• We provide Stability Studies for drug substance, such as protein and cell with reference to ICH guidelines. Provide storage conditioning chamber at conditions under liquid nitrogen, at -80°C, -20°C, 2-8°C and 25°C. 

Our Capability

​We  have many years of bio-pharmaceutical scale-up, optimization, and technology transfer experience.  This includes upstream cell culture scale-up to downstream purification process that meets GMP standards.

​Drug Manufacturing for pre-clinical to clinical supplies ​​

Our state-of-the-art production platform, which is designed to meet international GMP standard and guidelines, can provide qualified an material for their pre-clinical trial studies and also process development data to support their scale up production process. ​

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Large Scale Manufacturing

Taron team have many years of GMP manufacturing experiences which covers both upstream, downstream processing including aseptic fill-finishes and freeze drying process.   We provide Quality Control Testing and Method Development / Validation services base on our team experiences in biological drug product. 

We had track record in establishing and undergoes many years of operation in a GMP manufacturing facility at US, Canada, China, Hong Kong and New Zealand and familiar with various international standard and guidelines; such as FDA, EMEA, PIC/s and ICH.  

Taron has established collaboration agreement with other CDMO both in China and in Taiwan which allow our project can easily tech transfer from process development phase to GMP manufacturing up to 1000L batch production.  

Taron Solutions offers a broad spectra  of tests for the characterization of antibodies

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