HistoBlast: China Edition March 2020

march 2020 view of the laboratoryView of the laboratory from the lobby entrance

We are pleased to bring this update to you about our Chinese laboratory. Despite the coronavirus outbreak, we are very excited by the progress we are making for this landmark facility and very much appreciate your encouragement, enthusiasm and questions. We will provide these monthly updates as we approach our go-live date of June 2020.

We are proud to undertake this venture to provide high quality biomarker testing across multiple platforms in the dynamic and innovative Chinese oncology drug development environment. We are building our team, preparing quality systems, and ordering instruments. Our global teams are enthusiastically collaborating with our Chinese team to transfer biomarker assays to our laboratory in Jining.

This laboratory is of particular significance for us since it will be our first site that houses our combined platforms and leverages our LIMS, quality, and operations systems.


Where is your laboratory located?

We are located in the historic city of Jining (济宁), the birthplace of Confucius, in the rapidly growing province of Shandong (山东). Catch a high-speed train from either Beijing or Shanghai (we are right in between) and we will drive you from the train station to our lab. Jining, as a designated Chinese National-Level High-Tech Industry Development Zone, receives economic and development support from the national government. In the Shandong province, it is one of two such sites and has received the attention of international media for its innovations in various industries, especially biotechnology. The city is served by well-established courier and service organizations.

march 2020 dacheng hall
Dacheng Hall of Confucius Temple, Qufu
曲阜孔庙大成殿

Tell us about your lab.

march 2020 our building
Our building is located on the 3rd floor of this building. Each floor has 120,000 sq. ft.

We have constructed a purpose-built 30,000 sq. ft. (~3000 m2) facility. The building is located in an IVD high technology park. The construction project has been a highly collaborative effort with the city of Jining, and we have also established a productive relationship with the Jining University School of Medicine.

When will the lab open?

We plan to accept specimens around June of this year.

What services will you offer?

Our Jining laboratory will house these platforms — Histopathology, Flow Cytometry, Genomics, CYTOF, and Mass Spectrometry.

IHC, Digital Pathology, & FISH
We will start with IHC. The widely known PD-L1 clones and other standard immune markers will be available in addition to the commonly used IHC markers. Our instrumentation includes the Dako, Ventana, and Leica automated staining platforms. Slides will be digitally scanned and available for remote viewing. Multiplex IHC assays are on our transfer roster.

FISH and digital pathology services are also available.

Flow Cytometry
Our flow cytometry platforms include the Lyric and Fortessa instruments. We plan to introduce the Aurora Cytek platform later in the year. MDSC, TBNK, and immunophenotyping panels will be available.

Genomics
We are planning on introducing FFPE-based Nanostring panels, TMB, MSI, and other targeted NGS panels. Given the wide array of available genomic platforms, we welcome your input via this survey.

We will provide you with regular biomarker menu updates on our various platforms. We are also keen to hear your requests and have established an efficient assay transfer process.

How many people will be at the Jining laboratory?

march 2020 portraits
Dr. Li-Jie Zhang (left), Michelle Li (center), Susan Sun (right)

Presently, we have hired 9 persons and we expect to have 15 personnel when the laboratory opens. Our leadership team consists of clinical development veterans with more than a decade of experience each. Pathologist Dr. Li-Jie Zhang leads our team as the Medical Director and has served as PI for numerous oncology clinical trials in China. She is supported by Michelle Li (HGRAC, pharma experience, CRO) and Susan Sun (multiple large CRO experience). In addition to Dr. Zhang, we will have one other full-time pathologist when the laboratory opens.

We have employed three technologists who will perform the histopathology and flow cytometry assays. Our technologists receive training in Belgium to ensure standardization and quality practices. Subsequently, a colleague from either Belgium or the US will then spend an extended period in China, participating in the setup of an instrument or a process.

Other functions on-site include project management, data management, IT & facilities, finance, and human resources.

What does your timeline look like?

We share the timeline schematic below with the caveat that there may be adjustments. We will communicate these adjustments to you via this update. (Click to enlarge image.)

march 2020 timeline

Questions?

An informational presentation of our Chinese laboratory is available here.

For a conversation about our laboratory, please contact your project manager, business development executive, or This email address is being protected from spambots. You need JavaScript enabled to view it..

In our next issue, we will provide further updates on biomarker assays, our quality systems, and our personnel. You can send in additional questions This email address is being protected from spambots. You need JavaScript enabled to view it..