The United States Pharmacopeia (USP) to participate in the September 16 agenda, including a session on how its standards framework is closing gaps in mAb characterization.
The United States Pharmacopeia will present at the BioPharma Analytical Innovation Summit 2026, a one-day technical summit taking place September 16 at The Desmond Hotel in Malvern, Pennsylvania.
The free summit, powered by Agilent Technologies, brings together analytical development, QC, and late-stage R&D and formulation scientists from across Greater Philadelphia and the Mid-Atlantic. The agenda includes morning innovation sessions, three parallel modality tracks, live instrument demonstrations, an afternoon panel, and a networking social.
Attendees will have access to USP scientists at three points across the day.
The day opens at 9:00 a.m. with a plenary from Dr. Kishan Chandra of USP, “Enhancing Analytical Confidence in mAbs: USP’s Integrated Approach with Emerging Standards and Reference Standards.”
Dr. Julie Zhang, USP is set to lead the Protein & Antibody Therapeutics track. Dr. Edmond Biba, Principal Scientist in USP’s General Chapters – Science Division, co-presents a session on orthogonal technologies for biomolecule characterization with Agilent’s Derek Lohmann.
What the Plenary Covers
Per the abstract provided, monoclonal antibodies require robust analytical characterization to support quality, safety, and comparability. But there is no common global expectation for which analytical methods are appropriate, or for what analytical performance should look like.
The abstract states that the gap creates inefficiency and inconsistency in two places: in product testing itself, and in the interpretation of the resulting data.
USP’s existing tools address part of the problem. General chapters, reference standards, and analytical reference materials cover two categories of risk.
- Across biologics — microbial contamination, particulates.
- Specific to mAbs as a product class — aggregation, glycosylation.
According to the abstract, stakeholders identified two attributes where more product-specific guidance is needed:
- Charge variants
- Bioactivity
Emerging standards are USP’s response to that gap.
How USP defines emerging standards
The abstract is specific about scope:
- They are early-development concepts — not official compendial standards, and not proposed ones. They may be considered for compendial development in future.
- They provide public, science-based analytical methods and system suitability criteria.
- Their purpose is to support assessment and monitoring of method performance, while preserving flexibility in analytical approach.
- Product-specific specifications remain with the appropriate regulatory authorities.
Reference standards support the framework in practice as well-characterized materials used in method development, system suitability testing, validation, comparability studies, and performance monitoring.
The stated goal is improved method robustness, reduced uncertainty, easier regulatory alignment, and more consistent evaluation of monoclonal antibodies.
Context
USP published its first product-specific emerging standards for biologics on June 1, 2026, covering epoetin, interferon beta-1a, rituximab, and bevacizumab, with accompanying physical reference standards. They were released through USP’s Emerging Standards Platform and opened for public comment.
Also on the Agenda
Agilent application scientists will be on site alongside running instrumentation. Two of the systems are new this year.
- 6230C TOF — launched at ASMS.
- 1260 Infinity III FLD — a new detector module with a new flow cell, added to the Infinity III series.
A 10:00 a.m. innovation session covers HRMS-powered multi-attribute method workflows. Agilent states that its MAM solution for OpenLab CDS is aligned with USP General Chapter <1060>. That chapter, “Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins,” became official August 1, 2025.
The three midday tracks cover Peptide Therapeutics, Oligonucleotide & mRNA Therapeutics, and Protein & Antibody Therapeutics.
Why It Matters Regionally
The corridor from Malvern and King of Prussia through Philadelphia into South Jersey and Delaware carries a dense concentration of QC and analytical development groups.
It also carries a growing number of CDMOs — running other organizations’ methods, against other organizations’ expectations.
For those teams, method ambiguity carries a cost. Disputed results drive repeat investigations, repeat transfers, and delayed release.
The expertise that resolves those disputes tends to sit on the bench rather than in submissions. The scientist who knows whether a system suitability criterion is achievable is the one who has run the assay a thousand times.
A one-day regional summit puts that experience in the same room as the people building the framework.
USP has signaled the emerging standards portfolio will expand toward additional high-impact therapeutic proteins and monoclonal antibodies, making the current set a template rather than an endpoint.
Summit Fast Facts
| What | BioPharma Analytical Innovation Summit 2026 — a one-day technical summit powered by Agilent Technologies |
| When | Tuesday, September 16, 2026 · 8:30 a.m. – 4:30 p.m. ET |
| Where | The Desmond Hotel, One Liberty Blvd, Malvern, PA 19355 |
| Opens with | USP plenary, 9:00–9:30 a.m. — Dr. Kishan Chandra on USP’s integrated standards approach for mAbs |
| Tracks | Peptide Therapeutics · Oligonucleotide & mRNA Therapeutics · Protein & Antibody Therapeutics |
| Also on the day | Live instrument demonstrations, an afternoon panel, and a networking social |
| Who it’s for | Analytical development, QC, and late-stage R&D and formulation scientists across Greater Philadelphia and the Mid-Atlantic |
| Seating | Limited — capacity is capped |
Registration is open.
Seating at The Desmond is capped. Reserve a spot before the tracks fill.
Register for the BioPharma Analytical Innovation Summit 2026 →
