Ensuring quality drug products using sophisticated analysis and testing

With more than 27 years of experience in Analytical development, Syngene’s Analytical Development team is a leader in method development, method validation, method transfer, and application of analytical expertise to ensure the delivery of quality drug products for early as well as late-phase drug development programs. The team has expertise in developing phase-appropriate methods, validation, and transfer of the methods for drug substance and drug product (solid, semisolid, solutions, simple and complex long-acting parenteral formulations). Our team analyzes small molecules (RSMs, intermediates, and APIs), semi-large molecules (polymers, oligonucleotides), and biologics using a variety of spectroscopic, chromatographic, and physiochemical techniques.

Our expertise plays a vital role in supporting clients in the discovery and development processes of pharmaceuticals, fine chemicals, agrochemicals, and oligonucleotides. We ensure a high quality of service by monitoring key performance indicators or key quality indicators (KPIs/KQIs) that are defined at the beginning of the collaboration.

For each client project, we design customized solutions, define analytical protocols, develop and validate specific new analytical methods, perform characterization, stability, impurity identification, as well as undertake batch testing. All these services help ensure the specified drugs’ quality, safety, and efficacy.

Testing services

Our scientists provide comprehensive analytical solutions, including method development, transfer, validation, characterization studies, in-process, lot release, and stability analysis. The team develops high-throughput analytical methods for small, mid, and large-scale combi-Chem library molecules.

For process development or stability testing, we support multiple approaches. These include,

I. Analytical method development combined with in-house method validation
II. Developed methods transferred from the client, paired with validated in-house methods
III. Validated methods transferred from the client and verified through formal protocols.

We also offer expertise in microbiology testing, semi-preparatory and preparatory purification, impurity isolation, structural elucidation, and characterization.

Our analytical offerings include:

• Method Development: We have wide-ranging, hands-on experience in developing and optimizing stability-indicating analytical methods using modern analytical tools and techniques for a variety of molecules such as small molecules (UV active and inactive), polymers, lipids, and oligonucleotides. We also offer method development with specialized instruments for average molecular weight by GPC/RID, genotoxic impurities (GTIs) and nitrosamines, in vitro drug release methods using conventional and non-conventional dissolution techniques. Know more about our Nitrosamine Impurity Testing Center of Excellence.
• Method Verification/Validation: We support analytical method validation for drug substances (KRMs, intermediates, and APIs) and drug products (solid, semisolid, solutions, and parenteral formulations) in accordance with the Q2R1 guidelines of the international council for harmonization of technical requirements for pharmaceuticals for human use (ICH).
• Structural Characterization and Elucidation: We offer a full spectrum of services for compound characterization and structural elucidation of synthesized APIs using advanced analytical techniques such as ultraviolet spectroscopy, high-resolution mass spectrometry, tandem mass spectrometry (MS/MS), and 1D, 2D nuclear magnetic resonance (NMR).
• Reference & Working Standards Qualification: We prepare working reference standards by selecting the material with the highest purity from different batches of the same product and comparing them with the official reference standards. When official reference standards are not available, we qualify the material by subjecting it to additional purification processes until it reaches the maximum state of purity.
• Identification & Characterization of Impurities: We provide options to either develop a custom method or adapt an existing one for impurity isolation and characterization.

I. The study results are presented as a formal report suitable for regulatory submissions. We also characterize and identify   potential impurities and degradation products present in active pharmaceutical ingredients (API).
II. Our scientists utilize preparatory high-performance liquid chromatography (HPLC) to isolate impurities using several types of detectors and techniques. The detectors include ultraviolet detectors (UV), evaporative light scattering detector (ELSD), charged aerosol detector (CAD), and refractive index (RI). The techniques include gel permeation chromatography (GPC), mass spectrometry (MS), or supercritical fluid preparatory chromatography. The impurity isolation is followed by a detailed structure elucidation using MS, MS/MS, and NMR techniques.

• Prep HPLC/Chiral Purification: We support a comprehensive range of preparative HPLC services. We offer isolation, purification, and concentration of single components from crude samples or complex mixtures utilizing high-throughput mass-based auto-purification for small and large-scale library molecules. We can also separate multi-gram quantities of chiral compounds using preparative supercritical fluid chromatography (SFC).
• Residual Solvent Analysis: We perform residual solvent analysis so that the manufacturing processes meet ICH standards. Our scientists develop methods for gas chromatographic (GC) analysis using auto-liquid injector or head-space sampler methods.
• Elemental Impurity Analysis: We perform analysis of elemental impurities (Class 1, 2A, 2B, and 3) as per ICH Q3D (R1) for drug substances, their various intermediates, and raw materials.
• Method Verification/Transfer:  We transfer validated methods between laboratories and sites while maintaining their validated state, ensuring the same reliable results at the receiving laboratory.
• Stability Studies: We conduct stability studies as per ICH Q1A guidelines for drug substances and formulation doses. Our facilities include photostability testing as per ICH Q1B guidelines for drug substances and products. Additionally, we develop and validate analytical methods to cater to stability requirements.
• Phys-Chem Studies/5-Batch Analysis: We perform physical-chemical tests as per regulatory requirements and offer full services for 5-batch testing of agrochemical active ingredients to meet global regulatory compliance standards. We conduct more than ten, 5-batch analyses and method validations annually as per different regulatory requirements.