If you work in CMC, analytical development, regulatory science, or biologics manufacturing, chances are you have heard of the WCBP Symposium. But what exactly is this meeting, who is it for, and why do so many regulatory facing teams prioritize it every year?
Here we answer:
The WCBP Symposium, organized by CASSS, is an annual international conference focused on Chemistry, Manufacturing, and Controls for biologics and advanced therapies.
Unlike general biotech conferences, WCBP is designed for professionals who build, execute, and defend CMC strategies. It brings together industry scientists and CMC leaders, global health authority representatives and academic experts in sample analysis.
The goal is to align science, regulations, and emerging technologies in a way that works in real submissions.
Crystal Bio Solutions attends WCBP 2026 as exhibitor. to stay closely aligned with evolving regulatory and scientific expectations that affect client programs.
Meet Dr. Shiaw-Lin (Billy) Wu, Chief Scientific Officer & Head of CMC Analytical and Dr. Ye Gu, Chief Technology Officer & Head of Business Development.
📅 January 27–29, 2026
📍 Booth #18 | The Mayflower Hotel
🔗 Schedule a 1:1 meeting with Dr. Ye Gu https://calendly.com/bd_global-crystalpharmatech/30min
Our work spans:
CMC analytical method development and validation
Mass spectrometry based characterization
Comparability and analytical similarity strategies
Stability study design and interpretation
Regulatory ready CMC data packages
The theme of WCBP 2026 is Integrating Science, Regulations, and Digitalization for Global Patient-Centered Care.
This reflects how CMC expectations are evolving in practice. CMC strategies increasingly need to be grounded in strong scientific justification rather than precedent alone. Global regulatory alignment has become a requirement rather than a goal, especially for programs intended for multi-region development.
At the same time, data driven and digital approaches are reshaping how submissions are built, reviewed, and maintained. Ultimately, patient access depends on development strategies that are efficient, consistent, and defensible across regulatory agencies.
WCBP 2026 runs from January 26 to January 29, 2026.
The symposium is offered both in person and as a live streamed event. The in person meeting takes place at The Mayflower Hotel in Washington D.C., while virtual attendance allows global participants.
The program combines plenary sessions, parallel tracks, workshops, roundtables, mini case studies, and technical seminars.
Sessions cover advanced analytical approaches used to understand product quality, including:
Identity, purity, and structural characterization
Extended characterization strategies
Risk based control of critical quality attributes
Dedicated short courses and sessions focus on:
Fundamentals of mass spectrometry for protein therapeutics
Intact and reduced mass analysis
Peptide mapping and PTM detection
Structural and native MS
Multi Attribute Methods for development and QC
Applications in antibodies, ADCs, cell and gene therapies, and oligonucleotides
A core focus of WCBP is comparability, including:
Analytical similarity assessments
Managing manufacturing changes
Case studies across antibodies, vaccines, ADCs, and gene therapies
Regulatory expectations under ICH Q5E, Q6, Q12, and related guidance
WCBP 2026 includes in depth discussion on:
Evolving ICH Q1 stability expectations
Predictive and accelerated stability
Use of prior knowledge and platform data
Global alignment of shelf life justification
A dedicated digitalization track explores:
AI and machine learning in process and analytical development
Digital twins and predictive CQA monitoring
Structured and data centric CMC submissions
Cloud based platforms and reliance pathways
These sessions highlight how digital tools are shaping the future of regulatory submissions and global collaboration.
WCBP matters because it reflects how regulators actually interpret data, not just how guidelines are written on paper.
Health authority representatives actively participate in panels, workshops, and open discussions, offering direct insight into what they expect to see in submissions. These conversations clarify where programs commonly run into trouble, which issues tend to delay approvals, and how analytical and stability data are evaluated during review.
They also show what strong CMC justification looks like in practice, beyond formal regulatory language. For teams preparing or defending submissions, this type of perspective is difficult to gain elsewhere and often proves more valuable than written guidance alone.
The complete scientific program, including session descriptions, speakers, and formats, is available on the official WCBP website.