Manufacturing

 

Dedicated for Manufacturing Clinical Trial Supplies

Overview

The Neihu Parenteral factory minimizes the development time of new products and accelerates the time to market by focusing on clinical trial product supply, pilot batches, and submission batch production. The Neihu Excipient Factory is designed for tailor-made functional excipient such as different polymers for high-tech barrier products. In addition to advancing your research process, we can refine the development of products.

Our seamless connection from the drug development stage to GMP production dramatically reduces the amount of third-party time and labor costs, ensures maximum control, and provides accurate documentation. The Neihu factory offers the related GMP compliance and submission documents with a high traceability. Our flexibility to handle diverse projects even includes high-tech barrier products like liposomes. We have worked with many world-class partners from the Netherlands, Germany, Taiwan, and China. Our rich experience of manufacturing oil-based injections, liposomes, and microspheres gives TTY a reputation for fast, reliable, and superior quality services in the pharmaceutical industry.

 

With the highly flexible, state-of-the-art GMP facilities, which meet international regulatory standards, the Neihu Factory manufactures various injectable products and functional excipient

  • Parenteral Products
    • Lyophilized products
    • Liposomal  formulations
    • Microsphere formulations
    • Drug product containing peptides and  proteins
    • Aseptic bulk preparation
    • Oil-based Injections
    • Fill and finish of bulk materials produced elsewhere
  • Functional Excipient
    • PLGA polymer
    • Lipid ligand

 

History

  • Neihu Parenteral Factory designed compliance with the PIC/S GMP
    • 2007: Established
    • 2009: approved by TFDA
    • 2010: approved by EMA
    • During these years, we also have on-site audit by these reputable partner all over the worlds, from Netherlands, Germany, China, and USA etc.
  • Neihu Excipient Factory
    • 2013: Established and complied with “The Joint IPEC – PQG Good Manufacturing Practices Guide (2006)”.

 

Exceptional Facilities and Processes for High-Quality Products

To achieve the quality and efficiency, the Neihu Factory has many noticeable features to prevent cross contamination.

  • Neihu Parenteral Factory
    • Single production line decreases cross-contamination
    • We use disposable clean room garments to prevent contamination
    • Every product uses either dedicated or disposable manufacturing equipment
    • We can flexibly adjust the dedicated equipment to meet the needs of diverse projects
    • It is easy and convenient to introduce new production equipment into our facility
    • 24-hour continuous monitoring systems for particle counts, pressure differential, temperature, and humidity
  • Neihu Excipient
    • Able to produce high purity standard
    • Tailor-made polymers and ligands for different projects
    • Wide range of different types of PLGA/PLA polymer product (Mw 100,000~300,000)
  • Expertise in various fields

Our staff is well-educated, with over 70% having either a doctorate or master degree. From R&D to GMP compliance, from analysis method development to product manufacturing, personnel in different fields are fully versed and knowledgeable. With the knowledge and experience in many fields as process optimization, development of analysis method, and submission document preparation, we can devise tailored solutions to meet the most challenging projects. Our expertise can shorten the R&D developing timeline, reduce unnecessary cost, and improve the quality of product.

 

GMP Manufacturing Capabilities

  • Excipient Factory
    • PIC/S Class  D clean rooms
    • Lipid Ligand synthesis and purification system such as short peptide.
    • Polymerization system
    • Pulverizer
    • Batch Size: 5 kilogram
  • Parenteral Factory
    • PIC/S Class A, B, C, D clean rooms
    • Filling line ( Vial size from 2 mL to 100 mL)
    • Lyophilizer (3500 units * 2 mL)
    • 24 hour continuous monitoring systems for particle, pressure differential
    • Maximum batch size:  50 Liter
  • Packaging and Labeling
    • Packaging 
    • Vacuum packing 
    • Labeling services for packaged materials with security labels
  • Storage and transport- All our process meet the requirement of Good Distribution Practice.
  • The raw material and drug products are store in secure areas, and continually monitored.  All the areas are also equipped with alarms that notify staff when conditions move out of specification. This ensures that appropriate personnel are notified immediately so correct conditions can be restored within the limited time.