We know development. Here is what our scientists think about it.
The Model That Changed Biotech Twenty years ago, a credible pharmaceutical development program needed laboratories, equipment, and scientists on the payroll. The idea that a five-person team could advance a drug candidate from lead optimization to Phase II without owning a single centrifuge would have seemed implausible. Today it is routine. The virtual biotech model, […]
Deviations Are Not the Problem. The Response Is. In any GMP manufacturing environment, deviations will happen. A process parameter drifts outside its validated range. A raw material fails an incoming test. A batch record is completed incorrectly. These events are not evidence of a dysfunctional organization. They are the normal noise of complex manufacturing. What […]
Why Your CDMO’s Inspection Record Is Your Problem Too When a regulatory agency inspects a contract manufacturing organization, it is not just inspecting the CDMO. It is inspecting the GMP compliance of every product made at that site, including yours. A Form 483 observation or a warning letter to your CDMO does not automatically stop […]
Formulating Oligonucleotide Therapies: siRNA, ASO, and Beyond A Pipeline That Has Finally Arrived Oligonucleotide therapies have been in development for decades. The science was compelling from the start: target any gene in the human genome with exquisite specificity by designing a short nucleotide sequence that binds the corresponding mRNA. Switch off disease-causing genes. Restore lost […]
The Document Nobody Reads Until Something Goes Wrong Quality agreements are one of those documents that get negotiated carefully, signed by the right people, filed away, and never looked at again. Until something goes wrong. When a GMP deviation occurs, when a batch fails, when a regulatory inspection raises a question about oversight, the quality […]
The Problem with Crushing Adult Tablets A remarkable proportion of medicines given to children are unlicensed for pediatric use. Nurses crush adult tablets, pharmacists compound extemporaneous liquids, and parents split scored tablets into fractions. None of these workarounds are ideal. All of them introduce dose uncertainty. Some destroy formulation features, like modified release coatings, that […]
Why Patients Want Prefilled Syringes Ask a patient which they would prefer for a monthly self-injection: a glass vial, a needle, and a syringe they have to assemble themselves, or a prefilled autoinjector they click and hold against their arm. The answer is obvious. Prefilled syringes and autoinjectors have become the standard delivery format for […]
A Test That Needs to Mean Something Dissolution testing is one of the most widely performed analyses in pharmaceutical development. It is also one of the most frequently misunderstood. A dissolution test that cannot distinguish a good batch from a bad one is not a quality control tool. It is a formality. And a test […]
Why a US Site Matters For biotech companies based in North America, time zone alignment and proximity are not trivial. A development partner eight hours ahead means decisions made in the afternoon do not get actioned until the next day. Equipment access, sample shipping, and site visits all become harder when the facility is on […]
What Makes a Compound High Potency? The term high potency active pharmaceutical ingredient (HPAPI) refers to any compound with significant biological activity at very low doses, typically below 1 milligram per day in humans, or with occupational exposure limits in the microgram per cubic meter range. The category includes cytotoxic oncology agents, hormonal compounds, certain […]
Two Routes to the Same Goal When a BCS Class II molecule needs bioavailability enhancement and simpler approaches such as particle size reduction or salt selection have not provided a sufficient solution, amorphous solid dispersions are often the next logical step. The two dominant manufacturing technologies for pharmaceutical ASDs are hot melt extrusion (HME) and […]
Why Standard Module 3 Templates Fall Short for Nanomedicines The Common Technical Document (CTD) Module 3 template was designed for conventional small molecule and biological drug products. For nanomedicine products, including lipid nanoparticles, polymeric nanoparticles, and metal oxide nanoparticle systems, the template provides a useful framework but cannot accommodate the full complexity of the characterization […]
