ISPE发布寡核苷酸与多肽生产设施指南首版
Establishing a New Baseline for Oligonucleotide and Peptide Manufacturing Facilities
ISPE发布《寡核苷酸与多肽生产设施指南》首版，为相关生产设施的设计与运行建立行业基线。指南由全球主题专家团队编写，覆盖工艺理解、监管期望、设备、公用工程、自动化、风险管理和污染控制等议题，并明确不规定单一设施模型。
At the same time, peptide manufacturing which has been established for decades is entering an era of larger-scale production, driven in part by growing demand for peptide-based medicines, including GLP-1 therapies.
These parallel developments create new challenges for facility design, manufacturing capacity, contamination control, solvent management, sustainability, and operational efficiency.
The newly published First Edition of the ISPE Guide: Oligonucleotide and Peptide Manufacturing Facilities establishes a contemporary baseline for the design and operation of facilities manufacturing these increasingly important therapeutics, helping organizations align manufacturing processes with facility design in a manner that protects the process, product, and ultimately the patient, while ensuring operations remain cost-effective and sustainable throughout the facility lifecycle.
The Guide has been written in a comprehensive way that includes considerations across the entire facility design. This includes background for individuals new to the oligo and peptide industry and in-depth topics that experienced industry professionals will benefit from.
Jim Love
Oligonucleotide/Peptide Market Leader
CRB
Rather than prescribing a single facility model, the Guide establishes a baseline that organizations can use to evaluate their own products, processes, and business requirements.
A Guide Shaped by Industry Experience
The Guide was assembled by a global team of subject matter experts with extensive experience in oligonucleotide and peptide manufacturing. Their collective expertise spans decades of industry evolution, from some of the earliest GMP oligonucleotide manufacturing campaigns in the 1990s to the rapid expansion of peptide therapeutics and the continued advancement of purification and processing technologies.
The Guide reflects a collaborative effort across the industry while respecting the proprietary knowledge and operational experience of participating organizations. The objective was not to create a detailed recipe for facility construction, but rather to establish an industry knowledge base that supports informed decision-making and future innovation.
Addressing Today's Challenges and Tomorrow's Opportunities
One of the Guide's most important contributions is its recognition that traditional facility design philosophies alone cannot adequately address the realities of oligonucleotide and peptide manufacturing.
Facility design for oligonucleotide and peptide manufacturing is complex and challenging, as the manufacturing processes use both bacteriostatic and bactericidal organic-solvent-based operations as well as aqueous-based processes. A well-designed oligonucleotide or peptide facility enables efficient solvent-to-aqueous process flow while balancing GMP requirements with safety, environmental, and hazardous materials considerations.
As the industry has grown, I have struggled to find information specific to oligonucleotide process equipment and facility design. Standardizing these practices can help enable more cost-effective facility designs while supporting high product quality and the delivery of safe and effective treatments for patients.
Christopher Palte
Associate Director, Engineering and Maintenance
Agilent Technologies
This is why the Guide explores topics ranging from process understanding and regulatory expectations to equipment, utilities, automation, architecture, risk management, and contamination control. It also examines future developments that may significantly influence facility requirements in the years ahead.
Creating a Foundation for the Future
As new pharmaceutical modalities emerge, establishing an industry baseline becomes increasingly important. Shared principles help reduce uncertainty, support regulatory compliance, improve project execution, and enable organizations to focus resources where they deliver the most value to patients.
The ISPE Guide: Oligonucleotide and Peptide Manufacturing Facilities provides that foundation. By bringing together regulatory expectations, industry experience, and practical facility considerations, it helps create a common framework for one of the pharmaceutical industry's most promising and rapidly evolving sectors.
As oligonucleotide and peptide therapies continue to expand their impact on patient care, this Guide offers a timely resource to support the facilities that will manufacture the next generation of medicines.
来源：ISPE iSpeak 专家博客 · ispe.org