The timelines of ~11 months apply for linear, branched or cyclic peptides up to approximately 40 – 45 amino acids and with a batch size range of 50 – 600 g.
The peptide therapeutics market is experiencing unprecedented growth. Driven by breakthroughs in metabolic diseases, oncology and neurodegenerative disorders, the demand for peptide-based drug candidates is rapidly increasing, both in capacity for individual programs as well as number of candidates.
This fast expansion presents both an opportunity and a challenge for drug developers. While scientific innovation is accelerating candidate discovery, the race to reach the start of a Phase I trial has become increasingly competitive. For many biotech companies, the ability to start Phase I clinical trials quickly can be a decisive factor in securing investment, attracting partners, and maintaining a competitive advantage.
The complexity of fragmented supply chains
Today’s peptide pipelines contain hundreds of compounds in preclinical and clinical development, with injectables remaining the dominant route of administration. As the number of programs grows, so does the demand for development and manufacturing capacity.
Traditionally, moving a peptide candidate from preclinical development into the clinic involves multiple partners on the drug substance as well as drug product side. Multiple handovers between different process and analytical development teams slow down the overall timelines and introduce complexity and risk that needs to be managed by the customer.
Doing the Right Things at the Right Time
During the lifecycle of a peptide drug candidate as the manufacturing process matures over time, the central theme is the concept of phase-appropriate development and execution.
This philosophy can be summarized in a simple principle: do the right thing at the right time.
In the earliest stages of development – drug substance as well as drug product – the objective is not to fully optimize every manufacturing step or establish a commercial-scale process. Instead, the focus should be on generating sufficient process understanding to ensure manufacturability and security of supply.
For peptide drug substance development, this means leveraging proven platform processes and only applying targeted development efforts where necessary and indicated. Generic yet robust approaches for Solid-Phase Peptide Synthesis (SPPS), cleavage, purification, and isolation allow development teams to move efficiently while maintaining confidence in product quality and manufacturability during the initial scale up.
Activities more relevant to later clinical phases, such as extensive process optimization, cost-of-goods reduction, or full process characterization will be introduced when appropriate – of course building on the knowledge from early-phase development and manufacturing, following the CordenPharma Quality by Design (QbD) approach.
A key enabler of accelerated timelines is the ability to execute multiple activities in parallel. This means ensuring there are significant overlaps planned between different process stages during drug substance development and drug substance manufacturing. For moderately complex peptides of up to 45 amino acids, early-phase drug substance development can be completed in approximately ten weeks, when supported by established platform technologies and well-defined development workflows.
However, the biggest benefit concerning the acceleration of overall timelines for the complete program comes from overlapping activities between drug substance and drug product development and clinical manufacturing. For example, samples from confirmation experiments at the end of the drug substance development can already be used for drug product development in parallel to the production of the drug substance.
The Importance of Joined Analytical Development
Analytical development plays a vital role in establishing a reliable understanding of peptide quality, stability and degradation behavior. The challenge is to generate this knowledge efficiently and in a phase-appropriate manner, with the clear goal to have one phase-appropriate analytical method for drug substance and drug product release.
Modern analytical strategies rely heavily on modular development concepts and automated screening approaches. Early characterization of solubility, stability, chromatographic behavior, and forced degradation pathways helps build a foundation that can be expanded throughout clinical development without unnecessary repetition of work.
Equally important is the close collaboration between analytical teams supporting both drug substance and drug product development. Understanding how a peptide behaves in solution, aggregates under stress, or degrades under certain conditions can directly influence formulation decisions and ultimately improve the probability of clinical success.
From Peptide Drug Substance to Injectable Drug Product: One Integrated Journey with PepCellerate™
Recognizing the need for speed, efficiency, and reliability, CordenPharma has created PepCellerate™ – an integrated solution for peptide drug substance to injectable drug product for early-phase peptide programs.
PepCellerate™ brings together early-phase peptide API development and manufacturing at the CordenPharma site in Frankfurt as well as injectable drug product development and GMP manufacturing in CordenPharma Caponago. The activities on both sites are centrally managed by our global project management organization together with global quality and regulatory support and oversight.
By reducing organizational interfaces and avoiding unnecessary technology transfers, PepCellerate™ aims to accelerate the journey from candidate selection to IND or IMPD submission and ultimately to First-in-Human studies.
This gain in development speed will be a critical success factor and game-changing strategic advantage for our customers, especially in the early phases. With PepCellerate™, CordenPharma offers a unique and very competitive package allowing the release of the first peptide GMP drug product batch in under 11 months after project kick-off at the drug substance site.
