Everyone in biotech loves to talk about innovation . We pour billions into brilliant science. We celebrate breakthroughs. We publish impressive results. But behind the scenes? Programs don’t fail because the science doesn’t work. They fail because manufacturing doesn’t. And when that happens? Patients wait. Investors lose faith. Teams take blame for systems that never had a chance to succeed. I’ve lived this. I’ve watched operators get chewed out over deviations they were nev

A professor once told me: “Don’t blame the person. Blame the process.” That has stuck with me my entire career. Because blame culture doesn’t solve problems. It hides them. It shames the people who are trying their best with what they’ve been given. 📌 Real change happens when we ask: What system allowed this to happen and how do we fix it? That’s why I founded F2i Partners. I saw a gap that could hurt people. So I chose to build the solution. — I’ve been on production floor

CDMOs are incredible partners. But you can outsource: ✅ Execution support ✅ Facilities + equipment ✅ Even documentation You cannot outsource: ❌ Product ownership ❌ Patient safety ❌ Executive accountability When the FDA walks in, they’re not asking: “Did your vendor promise quality?” They’re asking: “Show me your evidence of control.” Bringing in experts reduces risk. Abdicating responsibility compounds it. Strong programs maintain: ✔ Transparent governance ✔ Defined decision

Ensure your therapy lands in the right hands. Gain access to our CDMO selection frameworks that will help lower operational risk, speed up timelines, and set your program up for long-term success.

Some teams sprint into manufacturing thinking: “We’ll clean up the tracking later.” But regulators don’t issue credit for future intentions. 🛑 If you don’t have traceability on Day 1, you don’t have traceability. Inspection readiness isn’t: ❌ Binder checks one month before PAI ❌ A heroic CAPA cleanup at the finish line Inspection readiness is: ✅ Every batch reviewed with rigor ✅ Training demonstrably linked to current instructions ✅ Deviations resolved based on science and r

People think validation is paperwork. But validation is risk translated into action. Every protocol is asking: What could go wrong? How would we know? What protects the patient if we’re wrong? When I see hundreds of pages of testing with no decisions tied to outcomes, that’s not validation. 📌 That’s just paper. Validation that actually protects patients: ✅ Defines risk up front ✅ Uses data to confirm fitness-for-use ✅ Drives operational choices — not paperwork volume Because

Biotech Growth & North Dakota’s Future Biotech is no longer a niche industry. It's one of the fastest-growing economic engines in the world . Expanding 3x faster than global GDP. 📈 Global Biotech Growth 9–15% CAGR depending on segment (full landscape but see below!) Compared to ~3% global GDP growth Significantly faster than traditional manufacturing This growth isn’t slowing — it’s accelerating. 🧬 Platform Technologies Driving the Boom Segment Current Value 2030–2033 Proje

In biopharma, few things cause more collective eye-rolls than a new FDA guidance that feels. Open to interpretation or that seems to repeat the same “old” news in slightly new packaging. It’s easy to think, “Haven’t we heard this before?” But maybe that repetition isn’t redundancy. Maybe it’s reinforcement. Because every time the agency revisits familiar ground  risk-based thinking, data integrity, process understanding it’s reminding us that these aren’t trends. They’re foun

The Reality of mRNA , and the Operational Frontier of Biomanufacturing Visualizing translation in motion. Each particle represents the delicate bridge between scientific innovation and operational reproducibility at the heart of CMC strategy 1. The Update: Phase II Results in Context In late October 2025, Arcturus Therapeutics released interim results from its Phase II ARCT-032  program -- an inhaled mRNA therapeutic designed to restore CFTR function in cystic fibrosis (CF)

Walk through any university incubator or startup accelerator and you’ll find it. A dozen brilliant ideas, a handful of groundbreaking discoveries, and one tragic truth: Most biotech startups fail. Not because the science is bad. They fail because the infrastructure isn’t there. --- The Innovation Trap Biotech founders often start with a bold vision. A new therapy, diagnostic, or platform that could change medicine. But somewhere between the bench and the cleanroom, innovation

GMP. Good Manufacturing Practice. It was designed to protect patients. It ensures consistency, safety, and control. But somewhere along the way, we started treating GMP as a ceiling, not a floor. We stopped asking, “How can we do better?” and started saying, “At least it’s compliant.” --- When Compliance Becomes Complacency In too many facilities, “GMP-compliant” has become synonymous with “ mission accomplished .” Documentation gets prioritized over design, approvals over i

Walk into any GMP facility and you’ll hear it whispered over coffee or muttered during protocol review: “Validation is broken.” We all know it, but few are willing to say it out loud. For years, validation has been treated like a bureaucratic ritual: a mountain of documents meant to prove compliance rather than performance. We generate protocols, execute tests, and issue final reports that may satisfy auditors, but do they really prove our processes are robust, reproducible,

Sometimes, the biggest contamination events start with the best intentions. The Situation: Cost Savings vs. Contamination Control It began with a simple proposal: reduce the air changes per hour (ACH) to save on HEPA filter replacements and HVAC energy costs. On paper, the idea seemed harmless. After all, particulate levels were always well below alert limits. The facilities team argued that fewer air changes would extend filter life and reduce maintenance downtime. Finance a

Big science is getting smaller — and that’s a good thing. 1) Verve Therapeutics (VERV) — In-vivo base editing for cholesterol Why it’s innovative:  Single-course base editing  to permanently switch off PCSK9  in the liver; aims for durable LDL-C reduction. Early human data and FDA Fast Track for VERVE-102 signal momentum. vervetx.gcs-web.com + 2vervetx.com +2 Catalysts to watch (next 6–12 months):  Dose-escalation updates, longer-term safety/LDL durability read-outs. Key ris

1. The Big Think: Base-Editing Meets Rare Disease Beam Therapeutics is at the forefront of base editing  , a next-gen gene-editing technique that modifies individual DNA bases without cutting both strands, theoretically reducing off-target effects. Wikipedia+1 The company is advancing programs such as BEAM-101 for sickle cell disease and others for liver or lung genetic disorders. Directors Talk Interviews+1 On paper this reads like the kind of breakthrough biotech story in

The Unique Complexity of Advanced Therapies Cell and gene therapies (CGTs) represent one of the most transformative advances in modern medicine. These products (e.g. CAR-T cells, AAV vectors, or mRNA-based constructs) are designed to modify or replace defective genes or reprogram living cells to treat disease at its root cause. But behind each breakthrough lies a uniquely complex manufacturing and validation challenge. Unlike traditional small molecules or even biologics, the

“Why Work Won’t Love You Back (and Why That’s Okay).” Because if you work in biopharma, you know how easy it is to fall in love with the mission.

At F2i Partners, we’ve designed a Skills Map Framework that captures the full spectrum of capabilities needed to thrive in the evolving biopharmaceutical industry.

In the world of biopharmaceutical development, the distance between discovery and delivery can feel like an entire universe. On one side are academic researchers driven by curiosity, discovery, and the pursuit of scientific truth. On the other are industry professionals guided by compliance, reproducibility, and regulatory rigor. Too often, groundbreaking ideas stall in the space between the two.

Every year, millions are lost not because equipment fails, but because communication does. Tech transfers between research, CDMO, and manufacturing teams often collapse under unclear ownership, mismatched expectations, or missing context. Why Transfers Fail Even the most technically sound process can falter when: ⛔️Process knowledge isn’t standardized. ⛔️SOPs don’t reflect how work actually happens. ⛔️Site readiness assessments miss facility nuances. ⛔️Teams operate under dif