Guide: Oligonucleotide and Peptide Manufacturing Facilities

Published: Aug 2026
Pages: 204

• Table of Contents
• Special Pricing for Emerging Economies

As oligonucleotide and peptide therapeutics continue to reshape the pharmaceutical landscape, manufacturers face a critical challenge: developing facilities that effectively balance regulatory compliance, product quality, operational efficiency, sustainability, and speed to market. The new ISPE Guide: Oligonucleotide and Peptide Manufacturing Facilities, delivers the industry's first comprehensive facility-focused resource dedicated to these rapidly evolving therapeutic modalities.

Developed by a global team of subject matter experts with decades of experience in oligonucleotide and peptide manufacturing, this guide establishes a practical baseline for the planning, design, construction, commissioning, qualification, and operation of GMP manufacturing facilities. Drawing upon lessons learned from some of the earliest oligonucleotide clinical manufacturing programs, the growth of peptide production, and advances in biopharmaceutical processing, the guide provides a contemporary framework for facility development aligned with current regulatory expectations and industry best practices.

Oligonucleotides and peptides occupy a unique position at the intersection of traditional small molecule and biologic manufacturing. While both rely on synthetic chemical processes and solvent-based operations, they also present distinct challenges related to contamination control, purification technologies, process scale-up, facility classification, and environmental management. These characteristics often result in varied interpretations of facility requirements and create a need for modality-specific guidance.

This Guide addresses those challenges through a holistic examination of the relationship between manufacturing processes and facility design. It explores how facilities can be configured to protect product quality, support patient safety, and maintain operational flexibility in a manner that is also cost-effective.

Readers will gain valuable insight into regulatory requirements and global GMP expectations, quality risk management strategies, critical-to-quality considerations, manufacturing processes, process equipment, utilities, support systems, facility layouts, architectural design, automation, mechanical systems, and electrical infrastructure.

This Guide also examines the management of flammable solvents, hazardous materials, waste streams, and environmental considerations that are particularly relevant to oligonucleotide and peptide production.

Specialized chapters address the unique process and equipment requirements of both oligonucleotide and peptide manufacturing, while cross-disciplinary sections provide guidance on facility philosophies and infrastructure common to both modalities. The guide further explores emerging trends that are expected to influence future facility design, including the rapid expansion of oligonucleotide therapeutics, growing commercial demand for peptide-based medicines such as GLP-1 therapies, increasing production scales, sustainability initiatives, and evolving global regulatory expectations.

Written for facility owners, process engineers, project managers, quality professionals, architects, engineering and construction teams, equipment suppliers, and regulatory specialists, this guide serves as a valuable resource for both new facilities and the modernization or expansion of existing operations.

As investment and innovation continue to accelerate across these therapeutic classes, the ISPE Guide: Oligonucleotide and Peptide Manufacturing Facilities provides the foundational knowledge needed to design and operate safe, compliant, efficient, and future-ready manufacturing facilities that support the delivery of life-changing therapies to patients worldwide.

Guide Core Team

Jim Love

Oligonucleotide/Peptide Market Leader

CRB

Zach Foster

Senior Director / Engineering

Alnylam Pharmaceuticals

Christopher Palte

Associate Director, Engineering and Maintenance

Agilent Technologies

Marc P. Pelletier, PhD

Director

CRB

Francis Ring

Assistant Director

Ionis Pharmaceuticals

Jan Bondoc

Process Architect

CRB

Hanson Chang

VP/GM, Engineering & Instrumentation

CSBio

Bryant Cook

Vice President, Facilities & Engineering

Wave Life Sciences

Matthew Leisge

Associate Director

Alnylam Pharmaceuticals

Christopher Lynch

Discipline Manager, Electrical

Arcadis

Adam Michaud

Senior Director of Engineering and Facilities

Nitto Denko Avecia, Inc.

For the full list of contributors to this Guide see Guidance Document Teams