Outsourced Pharma

Getting clinical supply chains right is genuinely difficult. Studies evolve, demand shifts, and any disruption to material availability can ripple through a trial in ways that are expensive and hard to recover from. That's the operational reality Thermo Fisher Scientific's distribution automation system is designed to address. The system centers on high-density storage using smaller bins, which improves space utilization without sacrificing retrieval speed.

Developing today's increasingly complex biologics requires more than simply accelerating individual development activities. Traditional platform-based approaches often struggle with non-standard antibody formats, creating disconnects that can delay development and complicate scale-up. This case study shows how Asimov and LOTTE Biologics addressed these challenges through an integrated development strategy that aligned scientific and manufacturing activities from the outset.

Technology transfer is one of those moments where a formulation that performed perfectly in development can quietly fall apart. Compression parameters shift, lubrication levels creep up, and suddenly you're troubleshooting lamination or tablet strength failures at commercial scale. That's exactly the risk the team faced during scale-up of a 40 mg fexuprazan tablet formulation.

If you're developing softgel formulations, you already know the frustration: stability data takes time, and packaging and formulation decisions can't always wait. Accelerated predictive stability modeling offers a way out of that bottleneck, and this ibuprofen softgel case study shows exactly what's possible.

If you're formulating high-dose tablets, you've probably hit the point where the active pharmaceutical ingredient (API) starts working against you. Poor flowability, lamination risk, capping defects: these aren't random occurrences. They signal that your drug load has crossed a critical threshold, and if you don't know where that threshold sits, you're running experiments to find it the hard way.

Poor solubility remains one of the most persistent obstacles in small-molecule drug development, and amorphous solid dispersions (ASDs) are a well-established strategy for addressing it. The harder problem is figuring out which polymer combinations will actually hold up, and historically that's meant running extensive experimental screens that eat time and material. There's a more targeted way to approach this.

If you're developing a poorly soluble oral drug, food effects can blindside you late in the program when they're expensive to address. The fenofibrate case study covered here shows what's possible when you move mechanistic modeling upstream. Using the OSD Predict framework, researchers combined physiologically based pharmacokinetic (PBPK) modeling with molecular dynamics simulations to understand why fenofibrate, a lipophilic prodrug, absorbs significantly better in fed versus fasted patients.

If you're working with a poorly soluble small-molecule compound, you already know the pain: screens that go on too long, material you can't afford to burn through, and timelines that slip before you've confirmed anything. A compound with aqueous solubility of just 0.015 mg/mL in FaSSIF media presented exactly that problem.

If you're evaluating manufacturing routes for olopatadine hydrochloride (the active pharmaceutical ingredient in Patanol and Pataday), the chemistry matters more than you might expect.

If you're running global trials with a lean internal team, the math gets uncomfortable fast: more countries, more sites, more patients, and the same headcount trying to hold it all together. That was the reality for NewAmsterdam Pharma (NAP) as they advanced obicetrapib, their lead investigational compound, through 11 concurrent studies, three of which were pivotal Phase 3 trials spanning 51 countries and 835 clinical sites. The supply chain challenge alone would give most ops teams pause.