Fractional CMC Leadership for Biologics
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, the firm helps companies advance programs from early development through IND-enabling activities, clinical supply, and early clinical development using pragmatic, phase-appropriate, outsourced development strategies.
Senior CMC expertise for lean biotech teams.
Strategic and operational support for companies developing complex biologics in outsourced and hybrid development models.
Andrés Abín-Fuentes is a senior CMC leader with 13+ years of biopharmaceutical development experience across fully outsourced and hybrid development models.
He has led biologics CMC strategy and execution from early developability through IND-enabling activities and clinical supply, including successful advancement of a bispecific antibody program into Phase 1 clinical trials.
His experience spans global CDMO and CRO selection, process development, technology transfer, GMP manufacturing oversight, CMC regulatory support, technical due diligence, and cross-functional leadership across research, clinical, regulatory, quality, and investment teams.
Andrés holds a PhD in Chemical Engineering from MIT, an MBA in Finance, and has held CMC and bioprocess development leadership roles at Deerfield Discovery and Development, Selecta Biosciences, Synlogic Therapeutics, Vertex, Goodwin Biotechnology, and Bristol Myers Squibb.
Services
Fractional and consulting support across CMC strategy, development planning, vendor oversight, manufacturing readiness, and technical assessment.
Fractional Head of CMC
Strategic and operational CMC leadership for emerging biotech companies that need senior expertise without immediately building a full internal CMC organization.
CMC Strategy & Development Planning
Phase-appropriate CMC development plans from candidate selection through IND and early clinical development, including risk assessment, timeline planning, budget input, and key decision points.
CDMO & CRO Selection and Oversight
Support for RFP strategy, vendor selection, technical evaluation, contract input, project oversight, timeline management, and issue resolution across global development and manufacturing partners.
IND-Enabling Development & Clinical Supply
Integrated support across drug substance, drug product, analytical, formulation, manufacturing, packaging, labeling, and clinical supply workstreams.
Biologics Manufacturing & Tech Transfer
Oversight of process development, scale-up, technology transfer, GMP manufacturing readiness, batch execution, deviation support, and manufacturing documentation review.
Technical Due Diligence
CMC assessment of external programs, platforms, assets, vendors, and investment opportunities, with focus on manufacturability, scalability, regulatory readiness, and development risk.
Expertise
Experience across multiple biologics modalities and CMC workstreams, with particular focus on outsourced execution and lean biotech environments.
Modalities
CMC Areas
Discuss a CMC consulting or fractional leadership need.
For consulting inquiries, fractional CMC leadership, technical due diligence, or collaboration opportunities, please reach out directly.
Andrés Abín-Fuentes, PhD, MBA
Founder & Principal Consultant
Abin Biopharma Consulting LLC
Email:
andres@abinbiopharma.com
Phone:
+1 (612) 850-0551