Research, Non‑GMP, and cGMP Material: What Actually Changes (and Why It Matters) Teams often use “research-grade,” “non‑GMP,” and “cGMP” casually—until a program nears a key

Tech Transfer Readiness: The Practical Playbook to Move Faster From R&D to Manufacturing Tech transfer is often treated like a handoff: R&D finishes, manufacturing starts,

Why CDMO “Project Governance” Is a Technical Advantage (Not Just Admin) When sponsors evaluate CDMO partners, they often focus on chemistry capabilities and equipment. That

Impurity Control 101: How Good API Programs Avoid Late-Stage Surprises Impurity issues rarely appear “out of nowhere.” In most programs, the warning signs show up

What to Send a Synthesis Partner to Get a Fast, Accurate Quote (and Avoid Scope Drift) One of the fastest ways to lose time in

From Bench to Batch: How to Plan the Transition From Research Compounds to API Development In discovery, speed matters. You need compounds quickly to confirm

What’s happening: ICH Q1 is consolidating stability expectations ICH has moved forward with a consolidated stability guideline, ICH Q1, intended to integrate core principles and

What happened: Q14 and Q2(R2) are now the direction of travel FDA published guidances for Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development

Metabolic medicines are driving peptide manufacturing decisions The obesity/metabolic drug race is accelerating, with new mechanisms and combination approaches competing for share. In December 2025,

Why this matters right now In December 2025, Eli Lilly announced a >$6B investment to build a new U.S. API manufacturing facility in Huntsville, Alabama—part

The industry signal: FDA is formalizing how AI should be trusted On January 6, 2025, FDA published draft guidance titled “Considerations for the Use of

Why “safe adoption” needs a framework AI is already improving how teams search, summarize, classify, and predict—but regulated environments add a simple constraint: if an

Why “lifecycle” is the modern default Traditional thinking treats method validation as a one-time gate: develop, validate, file, done. The modern view treats an analytical

Stability Programs for Small‑Molecule APIs: A Practical 6‑Step Framework Stability programs often fail in predictable ways: the protocol is “somewhere,” packaging decisions get made by

Uplifting API Supply Resilience: A Practical Strategy for Buyers API supply resilience is often discussed like an engineering problem—redundancy, inventory, alternate routes. Buyers know the

How to Read a Certificate of Analysis (CoA): 9 Checks Before You Accept a Lot A Certificate of Analysis is often treated as a formality—something

Managing Product and Process Changes: A Practical, Risk‑Based Approach Change is not the exception in pharmaceutical operations—it is the normal mechanism of improvement: better yield,

Research‑Grade vs. GMP‑Grade: When Each Makes Sense (and When It Doesn’t) “Research‑grade” and “GMP‑grade” are labels that get used as shorthand for risk. The problem

Shipping Temperature‑Sensitive Materials: Best Practices for CRT & Cold Chain Shipping temperature‑sensitive materials is one of the few operational areas where small execution details (pack‑out

Why supplier qualification should be “risk‑based” (not “one‑size‑fits‑all”) Supplier qualification is not a paperwork exercise; it is your mechanism to control outsourced activities and purchased

Why “API” is more than a chemistry label In day‑to‑day operations, “API” is often used as shorthand for “the active.” But in quality and supply