Ensuring Quality & Scale in GMP Peptide & Oligonucleotide API Manufacturing
Summary
In today’s biotech landscape, quality is essential. Good Manufacturing Practice (GMP) guidelines are the cornerstone of safe, effective, and consistent pharmaceutical production. For therapeutics based on peptides or oligonucleotides (TIDES), many of which treat complex or life-threatening conditions, GMP compliance is a foundational element of regulatory approval and patient trust.- Author Company: CPC Scientific Inc.
- Author Name: Poppy Yang
Growing Importance of Peptide & Oligonucleotide Therapeutics
Peptides and oligonucleotides are transforming modern medicine. Peptide-based drugs have become the fastest-growing segment of chemically synthesized therapeutics, with over 80 approved worldwide, more than 200 in clinical development, and hundreds in preclinical stages (Rossino et al., 2023).
Oligonucleotide-based therapies have also seen significant growth, with over 20 US and EU approved products to date (Vinjamuri et al., 2024). In 2024, four of the 50 novel drugs approved by the US FDA were either peptide or oligonucleotide therapies, clear evidence of their growing clinical and commercial relevance (Al Musaimi et al., 2024).
This surge in innovation creates demand for highly specialized manufacturing environments. Unlike traditional small molecules, TIDES are large, complex structures that require precise synthesis, purification, and strict GMP compliance when scaling to kilogram clinical supply.
Understanding GMP Standards in Pharmaceutical Manufacturing
As defined by global regulatory agencies such as the FDA, EMA, and NMPA, GMP ensures that medicines are consistently produced and controlled to quality standards. It covers every step of manufacturing to safeguard patient safety and ensure product consistency and traceability.
GMP facilities must operate under defined procedures, investigate deviations, and document all operations using ALCOA principles: data must be Attributable, Legible, Contemporaneous, Original, and Accurate (MHRA, 2018).
Why GMP Matters in TIDES Manufacturing
Peptides and oligonucleotides are highly sensitive to variations in manufacturing. GMP frameworks provide guardrails, ensuring that only materials meeting the highest quality standards will move forward.
As TIDES therapies progress into later-stage trials or commercial use, the complexity and scale increase. Maintaining consistency while scaling production requires large-scale reactors, high-throughput purification technologies, and validated controls. A manufacturer’s ability to uphold GMP at scale is a key success factor.
Quality Assurance & Compliance You Can Trust
At CPC Scientific, quality is built into every stage of manufacturing. Our QA team ensures full compliance with SOPs and batch documentation, while QC performs extensive analytical testing before any material is released. Cleanroom conditions, equipment calibrations, and data integrity are continuously monitored to maintain traceability and GMP alignment.
Our track record speaks to our standards. Our group has passed inspections by the FDA, EMA, TGA, MFDS, and NMPA, and holds ISO 9001 and ISO 13485 certifications. With nearly 25 years in the field, we understand regulatory expectations and consistently meet or exceed them.
Scalable GMP Peptide & Oligonucleotide Manufacturing
Our group’s Hangzhou GMP facility spans 26,000 square meters, supporting over 1,000 kilograms of peptide API annually with individual batch sizes exceeding 25 kilograms. We also support GMP-grade oligonucleotide production ranging from 1 to 17 kilograms annually.
In the United States, our new Rocklin, California site (41,000 square feet) will be operational in 2026, adding several hundred kilos per year of peptide API capacity and offering a US-based supply chain solution for dependable global supply.
Partner with CPC Scientific
GMP manufacturing is the critical link between scientific innovation and clinical reality. Partnering with an experienced GMP manufacturer ensures your peptide and oligonucleotide programs scale with confidence and CGMP compliance.
With over two decades of proven excellence, CPC Scientific has empowered our clients to accelerate hundreds of innovative new chemical entities into GMP development. More than 300 active pipelines from preclinical studies to Phase III trials reflect our commitment to driving scientific breakthroughs.
Ready to move your program forward? Contact us to discuss how we can support your therapeutic goals and bring your innovation to life.
