Independent analytical science consultancyAvailable for consulting

Priority Proteomics consulting

Analytical Development,
CMC & LC–MS consulting.

Senior-level scientific support for the decisions between the laboratory bench and regulatory filing.

Work directly with Jon DeGnore, Ph.D., to resolve a focused analytical question or provide broader analytical leadership across a development program.

Explore the services See consulting examples

Discuss a consulting needContact Priority Proteomicsmass.spec.software@gmail.com →

Consulting services

Support shaped around
the work ahead.

Choose the expertise your program needs. The scope and deliverables can be defined around a specific question, a development milestone, or continuing scientific leadership.

Analytical Development & CMC

Connect analytical strategy to the next development decision. Support spans active pharmaceutical ingredient (API), drug substance, and drug product, from candidate characterization through clinical development and filing preparation.

Areas of support: Method development, qualification, validation and transfer; comparability, stability, forced degradation, specifications, and analytical control strategy.
Possible deliverables: Analytical development plans, method protocols and reports, CMC gap assessments, and technical recommendations.

LC–MS & protein characterization

Resolve questions about identity, purity, heterogeneity, and impurities using mass spectrometry and complementary analytical methods. Bring practical interpretation to complex protein, peptide, antibody, and ADC data.

Areas of support: Intact and subunit mass, peptide and disulfide mapping, glycan and post-translational modification analysis, impurity assessment, and orthogonal characterization.
Possible deliverables: Characterization strategies, analytical data reviews, impurity assessments, and troubleshooting recommendations.

Regulatory & filing support

Translate analytical work into clear chemistry, manufacturing, and controls (CMC) content. Support includes authoring and technical review for IND, BLA, and IMPD submissions and responses to health-authority questions.

Areas of support: CTD Module 3 analytical content, supporting characterization packages, method documentation, regulatory data review, and scientific responses.
Possible deliverables: Draft analytical sections, reviewed data packages, identified evidence gaps, and technical response content.

Laboratory & outsourced workflows

Build the analytical capability a program needs, within the laboratory and across external partners. Connect instrument choices, methods, people, and documentation to a workable analytical process.

Areas of support: Laboratory setup, instrument selection, SOPs and qualification documentation, staff training, CRO/CDMO selection, scope development, and external data review.
Possible deliverables: Laboratory and workflow plans, technical statements of work, SOPs, training, and reviews of external methods and reports.

Selected consulting work

Experience applied
to real analytical problems.

Examples from Priority Proteomics consulting engagements, spanning outsourced data review, regulatory support, and laboratory operations.

ADC characterization

Impurity assessment for an IMPD

Reviewed outsourced analytical results and assessed unknown impurities in an antibody–drug conjugate drug product to support IMPD development.

CRO oversight

A clearer scope for external work

Supported CRO selection and contract development, reviewed the resulting analytical data, and redesigned the scope of work to generate more actionable results.

Workflow improvement

From six weeks to three

Improved a client workflow’s throughput by 50% and reduced turnaround from six weeks to three weeks.

Your scientific partner

Jon DeGnore, Ph.D.

Principal Consultant · Priority Proteomics

An Analytical Development, CMC, and LC–MS leader whose experience spans discovery, biologics characterization, laboratory operations, and regulatory submissions.

Industry experience includes leading analytical method lifecycle management, building an Analytical Development services division, and serving as interim QC functional leader during GMP migration. That work included more than 40 SOPs and instrument qualification protocols.

Hands-on expertise covers antibodies, ADCs, proteins, peptides, vaccines and adjuvants, and small molecules, with methods including LC–MS, chromatography, electrophoresis, and biophysical characterization.

Getting started

Start with the question
you need to answer.

Describe the analytical challenge, the development stage, and the decision or timeline driving the work. From there, we can discuss the scope, available data, and useful deliverables.

Start a conversation

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