Analytical capabilities

Over the decades, Bachem has built up very broad analytical know-how and has set industry standards for peptides. We accompany our customers through all clinical phases up to market approval with an analytical approach tailored to customer’s needs. We have extensive analytical expertise and offer all analytical services to ensure successful product development. Our vast platform of state-of-the-art analytical techniques is designed to meet all regulatory requirements for our products throughout the entire product life cycle. We provide a wide range of GMP compliant analytical services for our customers:

 

  • Method Development / Method Validation
  • Stability Studies (Hold Time, Developmental, ICH, FUST)
  • Stress Tests
  • Forced Degradation
  • Impurity Characterization and Profiling
  • Characterization of Aggregation
  • Reference Standard Qualification and Aliquotation
  • Nitrosamine Determination
  • Genotoxic Impurity Assessment and Analysis

Our analytical portfolio consists of, but is not limited to, the following techniques:

Chromatographic Techniques

  • Ultra / High Performance Liquid Chromatography (UHPLC / HPLC) with UV, Fluorescence, CAD, RI, MALS detection
  • Two-Dimensional Ultra High Performance Liquid Chromatography (2D-UHPLC)
  • Gas Chromatography (GC)
  • Ion Chromatography (IC)
  • Thin Layer Chromatography (TLC)

Mass Spectrometry Techniques

  • Ultra High Resolution Mass Spectrometry (ESI-Orbitrap)
  • High Resolution Mass Spectrometry (ESI-Q-ToF)
  • Matrix Assisted Laser Desorption Ionization Mass Spectrometry (MALDI-ToF/ToF)
  • Peptide and Oligonucleotide Sequencing (ESI- & MALDI-MS/MS)
  • Multiple MS/MS Techniques: Collision Induced Dissociation (CID), Electron Transfer Dissociation (ETD), Electron Transfer Collision Induced Dissociation (EtciD), Electron Transfer Higher-Energy Collision Dissociation (EThcD), Higher-Energy Collisional Dissociation (HCD), Ultraviolet Photo Dissociation (UVPD)
  • Ultra / High Performance Liquid Chromatography coupled with Mass Spectrometry (UHPLC-MS/MS / HPLC-MS/MS)
  • Two-Dimensional Ultra High Performance Liquid Chromatography coupled with Mass Spectrometry (2D-UHPLC-MS/MS)
  • Gas Chromatography coupled with Mass Spectrometry (GC-MS/MS Triple Quadrupole)
  • Thin Layer Chromatography (TLC) coupled with Mass Spectrometry (TLC-MS/MS)

Spectroscopic Techniques

  • Infrared Spectroscopy (IR)
  • Ultraviolet / Visible Spectroscopy (UV/VIS)
  • Raman Spectrometry
  • Fluorescence Spectroscopy
  • Circular Dichroism Spectroscopy (CD)
  • Nuclear Magnetic Resonance Spectroscopy (1H, 13C, 31P & 19F – NMR)
  • Oligonucleotide Melting Temperature (UV melting curve)

Other Techniques

  • Amino Acid Analysis (AAA)
  • Automated Imaging for Particle Characterization
  • Dynamic Light Scattering (DLS)
  • Elemental Analysis (CHN)
  • Enantiomer Content
  • Endotoxins (LAL test)
  • Gel Electrophoresis (Native & SDS-Page)
  • Heavy Metals (ICP-MS)
  • Micro Flow Imaging (MFI)
  • Polarimetry
  • Refractometry
  • Residue on Ignition
  • Sulfated Ash
  • Titration (redox, potentiometric, Karl-Fischer vol./coul.)
  • Total Organic Carbon (TOC)
  • Total Viable Aerobic Counts (TVC)
  • Turbidimetry

Data integrity

We are constantly working on our analytical data concepts. Our analytical software systems include laboratory information management system (LIMS), chromatography data system (CDS) and fulfill the highest compliance standards including computer system validation (CSV). Fully automated electronic workflows from analytical order via electronic documentation of lab executions, result transfer and controls in LIMS up to final generation of certificates of analysis ensure highest compliance standards and errorless electronic data pathways.

Electronic data processes are designed to avoid manual data transfers and supplemented by automated data processing and result reporting in our CDS system. Lean and fully automated result reports even for analytical tests of highest complexity (e.g. multi-component assays or complex analytical validation reports) are processed without manual data transfers.

Further topics of interest

GMP
Production

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Commercial
API

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CMC
Development

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Amino Acid
Derivatives

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Analytical
data Sheet (ADS)

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Quality &
Regulatory

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