BPS 2023

XeriSol: A non-aqueous peptide formulation approach for enhanced stability and solubility

Michael Neely

Consultant, Xeris Pharmaceuticals Inc.

ABSTRACT

Peptide drug formulations are prone to degradation and aggregation/fibrillation in aqueous environments. Our proprietary, commercially-validated XeriSol™ non-aqueous formulation technology platform is designed to address the limitations of aqueous formulations for peptide drugs. The solutions are formulated using FDA-approved biocompatible, non-aqueous solvents that have higher stability and solubility. The solvent prevents degradation and aggregation/fibrillation of the peptide and allows for development of room-temperature stable, ready-to-use, small-volume peptide formulations. We have formulated numerous peptides of commercial interest with the XeriSol technology including glucagon (FDA approved as Gvoke®, EMA approved as Ogluo®), insulin, pramlintide, icatibant, thyroid hormone, vasopressin, etc. In each case, the XeriSol platform allows us to achieve a higher concentration/solubility and stability. Further, certain aspects of the technology allow for creating a sustained release profile for certain peptides. This presentation will focus on opportunities created by the XeriSol platform to reduce risk and speed development for peptide therapeutics.

BIO

Michael Neely is retired from a 42 year career in the Pharmaceutical and Biopharm Industry. He was instrumental in founding Mallinckrodt’s Peptide CMO API manufacturing initiative in 1991 and has served in numnerous other manufacturing, marketing and Business Development roles. Neely holds a BSc in Chemistry from Washington University and MBA from the Olin School at Washington University. He currently consults in the Biopharmaceuticals industry and is under contract with Xeris Pharmaceuticals, Inc.

Information for BPS Presenters

The Boulder Peptide Foundation was established to further the science and knowledge of peptide technology to develop novel therapeutics, biomaterials, medical diagnostics and other beneficial uses for mankind. As part of this goal we run several programs to support career advancement, seminars and educational events. Join us on our mission to expand the applications of peptide science.

Information for BPS Presenters

The purpose of the Boulder Peptide Symposium is to encourage sharing of information related to peptide therapeutic development with an emphasis on the technical, scientific and regulatory aspects of the pharmaceutical development. Presentations that demonstrate original thinking or share experiences from case studies in product development shall receive priority over others.

The Boulder Peptide Symposium offers multiple opportunities for participants to present.

Oral Presentations in Scientific Sessions

The session topics for Scientific Program are Peptides in the Clinic, Drug Delivery, Chemistry of Complex Peptides, Spotlight on Discovery, and Peptide Showcase. Abstracts may be submitted via the Apply to Present page on the website. Submissions will be reviewed by the Scientific Advisory Board on a monthly basis and the speaker will be notified of a decision.

Presentation length: Format is 25-30 minutes slide presentation with 5-10 minutes for Q&A, with the exception of Peptide Showcase talks which are 10 minute slide presentations with 5 minutes for Q&A. Please confirm with your session chair to confirm the exact presentation length.

Invited Speakers: Speakers are requested to supply their presentation details 30 days after receiving an invitation to present.

Program Book Deadline: Final abstract and title must be provided no later than September 1st. No changes to the program are possible after this date.

Presentation Format: Oral presenters please provide your presentation slides to the A/V table on the day of your presentation.

Lodging: All speakers are requested to reserve their own room. Discount rates at the conference hotel are available until August 16th.

Registration: All speakers, excluding sponsored presentation speakers, receive a complimentary registration upon approval of the abstract.

Peptide Showcase Description

The Peptide Showcase is an opportunity for an individual or company to “showcase” new ideas, technology and pipeline assets. Priority shall be given to presentations from biotech and startup companies. Service providers and vendors are not eligible. Speakers in the session receive a complimentary event registration.

Posters

Posters can be presented on any topic relevant to peptides including original research, innovative products and technologies.

Eligibility- Any attendee (from academia, industry, biotech or vendor/sponsor) can present a poster. The presentation must contain original scientific thinking. To submit a poster go to the Submit a Poster link from the meeting menu. All submissions are reviewed on a rolling basis and will be notified of approval. September 1st is the last day to submit a poster abstract. Approved posters are published on the BPF website.

A 30 ” x 40″ board shall be provided with thumb tacks. Board will be on an easel and can be rotated for either landscape or portrait formats. Once you apply for a poster, you will get email confirmation that your poster was accepted. The poster session and number assignments will be emailed one week before the Symposium.

Poster boards shall be available for display from 8am to 8pm the day of your assigned poster session. See the program agenda for the poster session schedule.

Public Release

Every presentation at the Boulder Peptide Symposium is automatically recorded. Speakers are required to give consent for sharing of the presentation video with the peptide community.

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