Translating Stem Cell Programs to GMP: A Collaborative Approach to Overcoming Manufacturing Complexity
Moving stem cell programs toward GMP manufacturing requires navigating a complex set of process dependent factors that influence identity, function, potency, and safety. Because outcomes are highly sensitive to even small changes in workflow, raw materials, or operator handling, teams…
Tech-Transfer and Manufacturing for Scaling Biotech
At Advanced Therapies Week 2026, our Chief Technology Officer, Gregg Nyberg, joined a panel of industry leaders to discuss how advanced therapy developers are navigating the path from early-stage process development to commercial manufacturing. The conversation reinforced something we see…
Scaling AAV9 Manufacturing: A Blueprint for Clinical-Grade Gene Therapy Production
Scalable AAV manufacturing is one of the most persistent bottlenecks in gene therapy. High viral titers through triple transfection are difficult to achieve consistently, and downstream purification using scalable chromatography has been a challenge for the field for years. The…
From Research to Reality: Overcoming CMC Challenges in Cell & Gene Therapy
Translating an R&D asset into a human therapeutic is a risk-filled endeavor that can be complicated by a wide range of development and manufacturing challenges. This webinar reviews the importance of working alongside a partner that has experience developing a CMC…
Integrating Analytical Method Development and Quality Control
A Roadmap for Successful Advanced Therapy Development
Landmark Bio’s Mission to Prevent Cell Therapy ‘Do-overs’
Drug Discovery and Development interviews Landmark Bio CEO Ran Zheng on the realities of large-scale cell and gene therapy manufacturing and the need to incorporate the requirements for GMP and commercial manufacturing early on
Integrating AI & ML in Biotech Manufacturing: How Modern Technology is Revolutionizing the Production of Advanced Therapies
An MIT Sloan Career Development Office Conversation with Ran Zheng, CEO of Landmark Bio
Getting Tech Transfer Right First Time
A digital thread centric integrated IT/OT foundation
Optimization of In Vitro Transcription for mRNA Production
Millicent Lin, R.K. DeLong, Mathew Brier, Manish Tandon, Li-wen Wang, Yun Chen, Radouane Zouaoui, Aviva Joseph, Eli Kraus and Gregg Nyberg
Use of Conventional Flow Cytometry to Study Extracellular Vesicles
Eli Kraus, Yun Chen, Manish Tandon, Gregg Nyberg
Formulation Matters
RNA Nanoparticle Formulation, Process and Characterization R.K. DeLong, M.S., PhD and Eli Kraus PhD