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Our Team

Our Team

The founding members of Bioworkshops are industrial veterans with deep understanding of the technical chemistry, manufacturing, and controls (CMC) requirement to reliably deliver biologics that meet international regulatory standards. Their biologics development and manufacturing experiences are key ingredients in quickly establishing Bioworkshops and providing excellent services.

Highlights of the team’s experience in the past five years includes:

Developing over 55 antibody products, lots of them are in late clinical stage.Manufacturing products for clinical trial in US, Australia, and China markets. Compliance against US-FDA, EU, NMPA, TFDA and TGA regulations to file IND and BLA.

Support Functions

3 divisions to support development and GMP production

Taking full advantage of modern information and communication is critical to achieving efficient and compliant business operations. The backbone of our IT systems uses a reliable network infrastructure, using a modern hyper-converged infrastructure (HCI) structure to isolate office and production networks. This architecture provides strong system security, hardware redundancy, and minimal risk of data loss to ensure high availability and help rapidly deploy applications.

  • Network Architecture layer

    Redundant network and server architecture

    Physical and virtual isolation of office and production networks

    Redundant firewalls control network boundaries

    Limit off-site access to data

  • Operation support layer

    Fully licensed software

    Company-wide data encryption

    Data security and system monitoring of devices and applications

    System maintenance, triple backup of e-records, and archiving

  • Business layer

    MSOffice suite, DMS, Access control, CCTV, BMS, and CMS

    System administration

    GMP Computerized System Validation

    Business Intelligence

The goal of the Bioworkshops supply chain department is to provide materials and services that meet specification requirements in a timely manner at optimal prices.

"Sunshine Policy" of anti-corruption and ethical standards for all approved vendors.

Long term supply agreements with key suppliers to ensure consistency of quality and avoid out of stock.

Approval and qualification of suppliers for critical materials and services.

Cold chain distribution raw materials and products by qualified suppliers.

Inventory storage

Raw material sampling and distribution are carried out in segregated clean rooms.

Good manufacturing practice for materials with environmental requirements at room temperature, 2-8 °C, < -20 °C, -40 °C, -80 °C, and liquid nitrogen vapor cryostorage for cell banks.


Our engineering team is responsible for equipment operation and maintenance, field service, and EHS. As a support department, the work scope includes:

Maintenance and calibration programs.

24/7 monitoring and timely response for utilities.

Actively improve the system to maintain leading technology, improve efficiency, ensure operational safety, and improve user satisfaction.

Benchmarking the company's environmental and safety systems to international best standards and exceeding local compliance requirements.

EHS

As a leading biopharmaceutical company, Bioworkshops believes that good EHS performance is a critical factor to ensure business sustainability.

  • EHS Values

    Care for people with prevention

    Beyond compliance and continuous improvement

    Leadership accountability and everyone counts

  • EHS Believes

    All accidents are preventable

    Safety is everyone’s responsibility

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