Vol. 44 |  Vol. 44(3) – May / June 2026 | Cover Story

Empowering the Full Lifecycle of Drug Development

by Production

We accelerate pharmaceutical innovation to enable earlier access to good medicines

In modern pharmaceutical development, complex molecules, rising regulatory standards and pressure for robust IP protection demand more than traditional crystallization can deliver. Inefficient polymorph screening, weak process robustness and gaps between Drug Substance (DS) and Drug Product (DP) development often delay timelines and increase risk.

The Porton Pharma Crystallization Technology Platform is led by a team of scientists with extensive experience at the world’s top pharmaceutical enterprises and equipped with industry-leading instruments and process equipment. Our service scope covers comprehensive fields including solid-state research, crystallization process development, pre-formulation studies, particle engineering, and DS-DP co-processing, covering every critical stage of pharmaceutical CMC development.

 

 

 

AI-Driven Solid-state Optimization

By combining AI-driven computational simulation with automatic high-throughput screening platform, we optimize the solid-state forms and physicochemical properties of APIs, maximize the screening scope of crystal forms, salt forms and co-crystals and identify the optimal solution for each candidate compound.

 

Precision Structural Characterization

Supported by in-situ XRPD, SCXRD and Micro-ED, we can elucidate crystal structures of each crystal form, interpreting their physicochemical properties and predicting risks in drug substance (DS) and drug products (DP) development.

 

Preformulation & Solid-Strategic Selection

Rooted in solid-state chemistry, we adopt a forward-thinking approach that unifies API and drug product development. During preformulation, we conduct systematic evaluation and rigorous selection of API solid forms, fully aligning with the performance requirements of downstream formulation design.

 

PAT-Enabled Process Development & Scale-Up

During process development, advanced process analytical technology (PAT) tools — including FBRM, BlazeMetrics, EasyViewer and in-line Raman — are routinely applied to enable real-time monitoring and precise control. At the scale-up stage, we simulate key unit operations, including solvent swap, mixing, crystallization, filtration and drying, to improve process robustness, accelerate scale-up and ensure manufacturing success.

We solve unique crystallization challenges posed by new/novel modalities, such as PROTACs, peptides, nucleotides and radionuclides precursors.

 

Advanced Particle Engineering

From early solid-state study to commercial-scale manufacturing, guided by crystallization fundamentals, we utilize spherical crystallization, dry/wet milling, and tailored particle design to engineer API particles with performance-matched properties for therapy and manufacturing.

 

DS-DP Co-processing

Porton’s mature DS-DP co-processing bridges critical technical gaps between API and drug product development. Using innovative particle engineering–such as crystallization in porous excipient matrices or excipient-modified crystallization–we integrate APIs with traditional excipients. This approach optimizes key physicochemical properties including powder flowability, compactability, and hygroscopicity, boosting processability and final product stability.

 

 

 

Proven Results

To date, our platform has supported over 800 small-molecule APIs and intermediates, and nearly 2,000 projects across crystallization process and solid-state study. We are committed to providing full-process customized solutions for crystal form and crystallization process challenges in the pharmaceutical CMC stage.

Empowered by cutting-edge technologies and cross-functional expertise, Porton Pharma’s Crystallization Technology Platform empowers the full lifecycle of drug development and manufacturing. As a trusted global CDMO partner which you can rely on, we are committed to driving pharmaceutical innovation, streamlining development journeys and helping patients worldwide gain earlier access to good medicines.

 

Why Partner with Porton?

– Full-lifecycle support from preclinical to commercial
– Customized solutions for crystal form and process challenges
– Regulatory & IP-aligned development strategies
– Global footprint with R&D and GMP facilities across EU, the U.S. and China
– Cross-functional expertise to streamline your development journey

 

Ready to Transform Your Crystallization Process?

Visit our website to explore full capabilities & discuss your project

 

About Porton Pharma Solutions

Porton Pharma Solutions is a global company with over 4,300 employees and R&D and GMP-compliant manufacturing facilities across the globe. It provides customer-centric, innovative, and reliable CDMO solutions for Small Molecules, Tides, Biologics and Conjugates (such as ADCs, AOCs, DACs, PDCs, RDCs, etc.), as well as Advanced Therapy Medicinal Products, from pre-clinical to commercial stages.

 

PORTON
www.portonpharma.com
business@portonpharma.com
*(Please note: From Chemistry Today)*

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