06.11.26 -- CDMO Selection: Start With The Relationship, Not The RFP

Peter Skals, Head of Global Sustainability, shares how the company is integrating its climate and ESG strategy while simultaneously expanding its CDMO network and reducing its CO₂ footprint.

Setting up a CGT product for regulatory viability and commercial success means investing to empower process design, plus on-time planning of PPQ and CPV activities.

Cell and gene therapies offer transformative potential for treating complex diseases, but their manufacturing and global delivery face significant challenges.

Precision genome editing strategies that balance specificity and potency through advanced engineering workflows, AI‑driven optimization, and tailored editor design for clinical genetic medicines.

Common GMP pitfalls stem from poor scalability, late regulatory planning, weak tech transfer, unsuitable hosts, and inadequate quality systems, delaying biologics production timelines and budgets.

The ADC industry is expanding to supply targeted treatments to support unmet need and patient demand. To succeed, ADC developers must account for the manufacturing complexity of these molecules.

At AAPS, drug product experts discuss how formulation, stability, and analytical services enable robust CMC strategies, reduce development risk, and support confident regulatory decision‑making.

A targeted LC–MS investigation identifies molecular changes behind potency discrepancies, enabling accurate root‑cause analysis and stronger control of monoclonal antibody product quality.

Conducted alongside the Faculty of Medicine at Palacky University and supported by the Technology Agency of the Czech Republic, this project focused on translating research into a viable product.