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Resources

Topic
All Analytics Antibody-drug conjugates Bioanalytics Biologics Biosimilars Biostatistics Cancer Cell culture Clinical trials Contamination Drug development Drug product Drug substance EMA FDA GMP Mabion Manufacturing Microbiology Partnership Proteins Regulatory Vaccines Veterinary biologics
Type
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innovative biologics 2026

Innovative Biologics Expected Approvals in 2026

Antibody-drug conjugates, Biologics, Bispecific antibody, Clinical trials, EMA, FDA, Monoclonal antibody, Vaccines
Declaration of the objectives and scope of the European Biotech Act

EU Biotech Act Ignites a New Wave of Biologics Partnerships

Biologics, Clinical trials, EMA, Regulatory
release testing for-biologics

Release Testing for Biologics – Regulatory Requirements for GMP Compliance

Analytics, Manufacturing
antibody drug-conjugates development

Breaking Barriers in Antibody-Drug Conjugates Development

Antibody-drug conjugates, Cancer
Navigating regulatory approval of biologics: A guide for emerging biotechs Bringing a biologic to market is an increasingly complex task, especially for small and mid-sized biotech companies with limited regulatory infrastructure. Meeting sometimes divergent EMA and FDA expectations, following increasingly complex regulations, and avoiding pitfalls related to documentation requires early planning and cooperation. Cross-functional alignment is also crucial to avoid issues related to comparability and process development/design space/process validation. This whitepaper outlines the key considerations in regulatory planning and biologics development, offering actionable insights for sponsors preparing their therapies for market. Bringing a biologic to market is a complex task, but with strategic planning and the right partners, emerging biotechs can overcome the regulatory hurdles with confidence. Mabion’s deep understanding of both EU and US regulatory requirements, coupled with extensive hands-on experience in biologics development and manufacturing, positions us as an ideal partner for companies seeking to streamline their path to approval.

Navigating Regulatory Approval of Biologics: A Guide for Emerging Biotechs

EMA, FDA, GMP, Regulatory
protein characterization techniques

Protein Characterization Techniques for Biologics Development

Analytics, Biosimilars, Drug development, Proteins
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Contact

Find out how we may support your business.

bd@mabion.eu

Mabion

gen. Mariana Langiewicza 60
95-050 Konstantynów Łódzki
Poland

+48 42 207 78 90

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