Biologic drug stability – ensuring quality and confidence for SOL-116
The complex journey of bringing a biologic to market – part 6 As SOL-116 progresses toward Phase II trials, stability becomes a central focus in ensuring the product remains safe, ...
Growing Together: Redefining CDMO Partnerships Through Trust and Communication
When we hosted the workshop “Growing Together: Navigating CDMO Partnerships Through Clinical Phases” at Nordic Life Science Days in Gothenburg, we hoped to start a dialogue about what truly makes ...
Fill & finish – Finalizing the product for clinical use
The complex journey of bringing a biologic to market – part 5 With GMP production of SOL-116 completed, the focus shifts to Fill & Finish—the step where drug substance becomes ...
Joining forces to tackle cholera
The urgent need for better cholera vaccines The World Health Organization (WHO) estimates 1.3–4 million cholera cases and 21,000–143,000 deaths each year, showing that cholera remains a significant global health ...
Extracellular vesicles moving toward the clinic
Ola’s insights and future perspectives from ISEV 2025 Looking back to April this year, the world’s most renowned experts in the field of extracellular vesicles gathered in Vienna for the ...
Moving into GMP – Turning process into product
The complex journey of bringing a biologic to market – part 4 The transition into GMP manufacturing marks a defining moment in the development of a biologic drug. After extensive ...
Optimization of the isolation method for large-scale production of synthetic bacterial vesicles for cancer immunotherapy
Abstract Negar Ordouzadeh, Rossella Crescitelli, Agnes Zimmer, Petra Tjärnlund, Cecilia Lässer, Jan Lötvall, Kyong-Su Park Bacterial vesicles have emerged as therapeutic drug candidates to treat a wide range of diseases, including cancer. However, critical concerns remain ...
Linking the gap from development to robust manufacturing
The complex journey of bringing a biologic to market – part 3 It is a critical shift for companies when transitioning from early development to clinical production, where you transfer ...
Viral vaccine manufacturing for clinical trials
Viral vaccines are entering a new era Vaccines have played a pivotal role in controlling infectious diseases for more than a century. Often regarded as one of the most impactful ...