Early-Phase Development And Manufacturing Services
At Acceleration Hub, we work with emerging biotech companies and large pharma partners, combining route selection, process development, analytical capabilities, and manufacturing into one coordinated approach - including expertise in highly potent APIs and controlled substances.
With experienced teams, established processes, and dedicated infrastructure, we enable efficient project progression under tight timelines and evolving requirements.
From concept to clinical supply
Process development
The Acceleration Hub applies phase-appropriate process development from early development through GMP manufacturing, supporting efficient progression from initial routes to robust manufacturing processes.
Our teams focus on translating medicinal chemistry into scalable, reliable processes, using a structured approach that integrates process understanding, quality-by-design principles, and data-driven development.
Broad experience across molecular scaffolds enables efficient development of new chemical entities and APIs, with a clear focus on scalability and transfer into manufacturing.
Analytical capabilities
The Acceleration Hub offers comprehensive in-house analytical capabilities, including ICH-compliant stability studies and full support for controlled substances.
Services include phase-appropriate analytical method development, validation and transfer, impurity identification, preformulation studies, and release and stability testing, aligned with regulatory requirements.
- Mass spectroscopy
- Nuclear magnetic spectroscopy
- Physical property characterization
- Liquid Chromatography
- Gas Chromatography
- Wet Chemistry tests
- Full-spectrum ICH stability studies
Regulatory support from development to approval
The Acceleration Hub provides regulatory expertise across all development stages, supporting global filings from early development through commercial approval.
Capabilities include CMC documentation, compliance with international regulatory requirements, and support for submissions to major health authorities, ensuring efficient and reliable progression through regulatory milestones.