Guide: RNA-Based Therapeutics Manufacturing

Published: Sep 2026
Pages: 140

• Table of Contents
• Special Pricing for Emerging Economies

RNA therapeutics are transforming not only modern medicine but also the way pharmaceutical facilities are designed and operated. The success of mRNA COVID-19 vaccines accelerated the emergence of RNA technologies, moving them from a niche scientific field to a rapidly expanding therapeutic platform that includes vaccines, cancer immunotherapies, protein replacement therapies, and gene-editing applications.

The ISPE Guide: RNA-Based Therapeutics Manufacturing, intends to outline and establish industry best practices for RNA-based therapeutics. It defines core principles that set RNA-based therapies apart from more traditional medicinal products based on their therapeutic modality and regulatory framework while providing a path to design and build compliant and efficient RNA manufacturing facilities using the In Vitro Transcription (IVT) process.

This Guide differentiates RNA-based therapies between classic (e.g., mAb) and synthetic (e.g., oligonucleotide and peptide) biologics. It focuses on the synthesis of the RNA drug substance and product and excludes precursor and starting material (e.g., plasmid) manufacturing.

Rather than relying on legacy facility approaches, this Guide promotes the adoption of a science-based, risk-focused design philosophy. This enables companies to tailor their facility design to the specific needs of RNA products. With the potential implementation of advanced technologies, a new generation of facilities is possible that ensures the supply chain while reducing operational costs and expanding access to vaccines and new drugs. The result is a new manufacturing paradigm designed to unlock the full potential of RNA therapeutics and shape the future of medicine production.

Developed by experts across research, development, engineering, regulatory affairs, and quality assurance, this Guide integrates state‑of‑the‑art engineering practices with the evolving scientific and regulatory landscape to define the core principles that characterize RNA-based production facilities and distinguish it from other platforms. Manufacturers, engineers, quality professionals, and regulatory specialists will benefit from this Guide as they navigate the rapidly developing field of RNA therapeutics.

Guide Core Team

David Estapé, PhD

Technology Manager, Biotechnology

CRB Group GmbH

Angelo Bernardis

SME Process - Life Sciences

Jacobs Italia SpA

Francesco Cicirello

Senior Director, Global Quality Compliance

BioNTech US Inc.

Steven Attig

Fellow, BioProcess Design

CRB

James Blackwell, PhD

President

Windshire Group, LLC

António Grilo, PhD

Technology Transfer Expert

Medicines Patent Pool

Emily Heffernan

US Director, New Process Technology

Arcadis US

Bernhard Janowski, PhD

Project Manager Operations

Wacker Biotech GmbH

Stefan Kappeler, PhD

Senior Director Biopharma & Regulatory

Exyte Management GmbH

Diego Schmidhalter, PhD

Partner

Alpha Lyncis AG

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