Telephone sharing button Contact Us mailbox sharing button wuxixdc_info@wuxibiologics.com
arrow_left sharing button
arrow_right sharing button

Services & Solutions

Bioconjugation Process Development


Experience and world-class expertise for all your bioconjugate and ADC needs

 

To support CMC-stage development activities, we have established a highly-trained and experienced process development team for antibody drug conjugates (ADCs) and other drug bioconjugates or diagnostic and imaging reagents. Our expert staff provide a wide range of process development, scale-up, and tech-transfer to GMP manufacturing services for our clients. To date we have advanced more than 100 R&D projects towards or at IND filing stage and provided one-stop development support for over 40 different products that are now in clinical trials.

 

The WuXi XDC Process Development team has extensive experience with many types of conjugation technologies, including cysteine-, lysine-, THIOMABTM-, non-natural-amino-acid-, enzyme-assisted-, glycosylation-based-, and our proprietary WuXiDAR4TM-based-conjugations as seen in the process flows described below:
 

We also have vast experience in the conjugation of different linker-payload combinations. Beyond cytotoxins like auristatin, maytansine, PBD, and deruxtecan, we have achieved conjugation of proteins with non-toxic functionalities such as PEG, peptides and oligonucleotides.

 

Development of an extensive number of downstream unit operations and purification steps have been established for a wide variety of different bioconjugates including development of a series of platform purification technologies for ADCs. These purification schemes include UFDF and various column chromatography technologies such as IEX, HIC, and protein-A and utilize state-of-the-art instruments and equipment to perform custom processes of all types and scales. See the table for examples of the type of instruments and equipment utilized in our conjugation/purification laboratories and pilot manufacturing facilities.
 

Bioconjugation Operations Small Scale (<0.5 L) Large scale and Non-GMP manufacture (0.5~60 L)
Linker-payload Handling Flow Sciences Horizontal Laminar (OEB-5);
Biologics Safety Cabinet (BSC-II)
Verified Laminar flow hoods (Car)
Conjugation Water/Metal bath; Incubator Glass jacketed reaction system;
Single-use disposable mixer
Purification Tools Centrifuge; Spin Desalting; Ultrafiltration; Dialysis; 50-88 cm2 Millipore Ultracel/Biomax Cassette TFF cassette Peristaltic Pump and diaphragm pump system;
0.11 – 1.14 m2 Millipore Ultracel/Biomax Cassette and Pall OmegaTM Cassette
Polishing Akta Avant and Pure;
Tricorn, Hiscale, XK, etc.
Akta Pilot and Ready;
BPG etc.

Quality by Design (QbD) Approach

Based on the contemporary concept of Quality by Design (QbD), we optimize processes by focusing on critical quality attributes (CQAs), and scale-up from the processing of micrograms to hundreds of grams to achieve controllable and stable pilot / non-GMP and GMP manufacturing. We have the capability of generating more than 50 batches (hundreds of grams per batch) of non-GMP products per year.

 
Under the Quality Assurance (QA) system, the Process Development team strictly adheres to quality practices and manages personnel, equipment, materials, sites and documents (e.g., SOPs, changes, deviations, corrections, and preventions) to help ensure right-first-time execution.
 

Notice:

You are leaving WuXi Biologics Website, after which our Privacy Notice will not apply. Please keep it in mind the protection of your privacy. Are you willing to proceed?