Solid form control of a drug substance: Ensuring robustness during scale-up

  • Webinar
  • 16 May 2023, 16:30 - 17:30 CEST

About the webinar

Technobis Crystallization Systems hosted a free webinar together with Malvern Panalytical.

With the increasing prevalence for solubility limited drugs in R&D pipelines, there is in turn a greater level of attention given to optimizing and controlling the solid form. Whether it is to improve drug release in vivo or stability on the shelf, selecting the right polymorphic form can be critical to product performance. Alongside that is the protection of intellectual property rights brought about through crystal structure definitions in patent registrations. Hence, the solid form is typically specified in early development and maintained through to commercial production. The challenge then becomes in ensuring solid form control through scale-up, formulation and storage.

Concept Life Sciences take drug substance from milligram to kilogram scale with reliable control of solid form. In this webinar, we describe how Process R&D team in Chapel-en-le-Frith worked with Analytical Scientists in Bradford, to develop a re-crystallization process for scale-up. We will discuss how the latest solid-state tools including the Crystal16 instrument of Technobis Crystallization Systems and Empyrean X-ray diffractometer of Malvern Panalytical to map the metastable zone was used and confirm polymorph purity. By doing so, Concept Life Sciences was able to improve yield and avoid uncontrolled secondary nucleation. The outcome was a more robust process to re-crystallize our client’s drug substance, up to 10’s of grams in scale.

This webinar is open to researchers interested in crystallization, looking to solve day-to-day crystallization challenges and optimize their best practices.


Dr. Pantelis (Leon) Xydias

Senior Scientist - Physical Characterisation at Concept Life Sciences

Dr Pantelis “Leon” Xydias, after obtaining his PhD he worked in the University of Glasgow as a Postdoctoral Associate on MOFs as drug delivery materials. Moving to the private sector he worked as a Senior Analyst with a speciality in Solid state and Physical Characterization in international CROs before moving to CLS to apply his solid state expertise on APIs. His expertise revolves around PXRD, Gas adsorption and Particle characterization.

Dr. Jennifer Morton

Principle Research Scientist at Concept Life Sciences

Dr Jennifer Morton is a synthetic organic chemist at Concept Life Sciences.  After completing a PhD at the University of Leeds, she joined Peakdale Molecular (now Concept Life Sciences) and has worked on numerous chemistry projects for clients.  Jennifer now concentrates on process research and development projects, and has particular interests in developing recrystallizations and in using Design of Experiment for reaction optimization. 

Dr. Carmen Guguta

Global Head of Business Development and Marketing at Technobis Crystallization Systems

20 years of experience in pharmaceutical development cycle, from discovery to formulation, covering small molecules, drug substance and drug product.  Deep experience in solid state chemistry. Previously worked with Avantium and Crystallics, contract research organizations.

Holds a PhD degree in Pharmaceutical Solid-State chemistry from Radboud University Nijmegen, The Netherlands.

Currently Dr. Carmen Guguta is the Global Head of Business Development & Marketing at Technobis Crystallization Systems, leading a team of highly skilled and experienced scientists and marketers. Her team focuses on unlocking new markets and market segments by developing new applications and establishing new collaborations. Since 2021, she is the chairwoman of the Dutch Association for Crystal Growth.


Webinar recording