Flow Chemistry: A Scale-Up Solution For Modern API Development And Manufacturing
 

Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can facilitate scale-up, improve product quality, and even address some of pharma’s biggest challenges, such as drug shortages and recalls.

What You Need To Know To Avoid Costly Delays In Your API Scale-Up
 
Traditionally, the development of a small-scale synthesis for an active pharmaceutical ingredient (API) and its scale-up to meet the materials demand for clinical trial phases is a sequential activity that passes through multiple sets of hands. If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy.
Avoid The Fallout From Incompatibility Between Your API And Its Formulation
 
It is critical the experts creating a drug product’s formulation are aware of any reactions that can occur between an API and a tablet’s excipients. This enables the correct choice of excipients, avoids unpleasant surprises at a later stage, and allows the focus to remain upon the manufacturing scale-up of both the drug substance and the formulated product.
Six API Challenges That Could Be Slowing Your Development And How To Avoid Them
 
The challenges for new drugs looking to enter the market are numerous and varied. But many are self-inflicted — especially in small molecule development. A dangerous perception persists that, aside from highly potent APIs, small molecule medications have simple process requirements. Having a solid understanding of the most common API challenges can help to avoid development delays, rework, or outright failure.
Solutions
Give Your Molecule Its Best Shot At Success
 

The path through drug development is marked by detours, roadblocks, and very few shortcuts. A streamlined drug development program, designed specifically for small and emerging companies, combines your drug substance, drug product development, and clinical manufacturing into a single solution to accelerate your discovery to proof of concept.