Abin Biopharma Consulting LLC
Strategic CMC Leadership for Emerging Biologics Companies
About Abin Biopharma Consulting
Abin Biopharma Consulting provides fractional and consulting CMC support to emerging biotech companies developing biologics, bispecific antibodies, ADCs, gene therapies, recombinant proteins, and other complex modalities. Led by Andrés Abín-Fuentes, PhD, MBA, our firm delivers pragmatic, phase-appropriate outsourced development strategies that help companies advance programs from early development through IND-enabling activities and clinical supply.
We specialize in providing senior CMC expertise without the overhead of building a full internal organization. Our strategic approach combines deep technical knowledge with practical business acumen, enabling emerging biotech companies to navigate the complexities of biologics development efficiently and cost-effectively while maintaining regulatory readiness and manufacturing excellence.
Our Services
Fractional Head of CMC & Strategic Leadership
Strategic and operational CMC leadership for emerging biotech companies that need senior expertise without immediately building a full internal CMC organization. Includes CMC strategy development, phase-appropriate planning from candidate selection through IND, risk assessment, timeline planning, and key decision point guidance.
IND-Enabling Development & Clinical Supply
Integrated support across drug substance, drug product, analytical, formulation, manufacturing, packaging, labeling, and clinical supply workstreams. Comprehensive oversight of CDMO and CRO selection, vendor evaluation, contract management, and project execution across global development and manufacturing partners.
Biologics Manufacturing, Tech Transfer & Technical Due Diligence
Oversight of process development, scale-up, technology transfer, and GMP manufacturing readiness. Includes batch execution support, deviation management, manufacturing documentation review, and CMC assessment of external programs, platforms, assets, and investment opportunities for manufacturability and regulatory readiness.
