In early-stage biotech, investors often look first at leadership, then pipeline. But savvy entrepreneurs know that CMC tells the truth, because it’s the bridge between promise and product. Why CMC Is a Business Asset Strong Chemistry, Manufacturing, and Controls (CMC) data signals: Manufacturing scalability Regulatory credibility Risk mitigation in supply chain and release When you invest in clean documentation, coherent control strategies, and process validation plans aligne

For biotechs expanding globally, the challenge isn’t just meeting FDA requirements. It's harmonizing with EMA, MHRA, PMDA, and Health Canada. The Pitfall: Single-Market Design Thinking Too many startups design around one regulator, only to rebuild later. Good practice means designing processes, documentation, and facilities that align with multiple regulatory frameworks from day one. Good Practice Principles Build with harmonization in mind: Align your validation protocols wi

In biopharma, validation is often treated as a regulatory checkbox or something you do at the end of development to satisfy auditors. At F2i Partners, we see it differently. Validation, done right, is strategy. It’s a lever for efficiency, risk reduction, and market acceleration. From Reactive to Strategic Traditional validation starts after processes mature. But by then, critical decisions equipment selection, sampling plans, and workflows are already locked in. Strategic va

In biotech, we live in the age of data, but data alone isn’t intelligence. The real breakthrough happens when statistical rigor meets artificial intelligence (AI). So, how are they connected and why does this relationship matter for the future of biotech? 🔹 1. Statistics vs. AI: Not Competitors, but Collaborators Statistical models are about understanding why something happens. They’re interpretable, grounded in theory, and help us make inferences. AI models (think machine

Industry Insights by F2i Partners The biotechnology industry often celebrates breakthroughs in the lab, but real value is realized when those discoveries can be manufactured, validated, and delivered at scale. Few examples illustrate this tension between innovation potential and execution reality better than Arcturus Therapeutics (NASDAQ: ARCT) — a company quietly advancing next-generation mRNA medicines while navigating a turbulent investor landscape. --- 1. The Market Narra

A rare sight in biotech: a late-stage asset abandoned by a big pharma is being revived—not because the biology changed, but because the...

When BioPharma Dive reported this week that Regeneron’s Libtayo gained a new FDA approval in the adjuvant setting for cutaneous squamous...

In a development that sent shockwaves through the biotech sector, Fortress Biotech recently received a Complete Response Letter (CRL)  from the FDA for its promising gene therapy candidate CUTX-101 . The news caused shares to plummet and raised critical questions about the industry’s ability to consistently deliver therapies that meet both clinical and manufacturing standards. While the FDA did not cite clinical efficacy concerns, the decision underscores a reality that biote

We love to celebrate scientific breakthroughs, but for every success story, there are dozens of programs that fail after proof of...