Reliable Solutions. Trustworthy Data. Confidence from Discovery to Release

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We help pharmaceutical researchers and manufacturers in innovating and producing pharmaceuticals that advance global health - by providing high-precision analytical instrumentation and intelligent lab automation. With this, efficient and regulatory compliant workflows can be established that enable customers to get reproducible results and make confident decisions, from candidate nominating to batch release.

Fields of Application

Drug research

With scalable, compact and precise solutions, we help you streamline and adapt your development processes and get the right data to nominate your candidates.

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Life Sciences

Robust and space-saving solutions integrate effortlessly into your lab environment – reagent-agnostic and ready for the challenges of discovery.

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Gene and Cell Therapy

Our integratable solutions help you advance in developing new therapies and reduce developing costs.

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Quality Control

We help you to set up efficient product quality control and process validation, in compliance with applying pharmaceutical regulations.

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Clinical Samples

Our systems for sample preparation and sample feeding are the basis for reliable clinical analysis results which form the basis for diagnosis and therapy.

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Highlights

  • Comprehensive elemental analysis portfolio for detection of content and impurities in the trace and ultra-trace range
  • Compact analytical instrumentation with outstanding size-to-functionality ratio
  • FDA 21 CFR Part 11 Compliance software module for analyzers and measurement instrumentation
  • Unique sample preparation systems for clinical samples
  • Liquid handling expertise of over 20m years with key components of automation developed and produced in-house
  • Only widely available liquid handling station enabling parallel pipetting in 1536 format
  • Pharma-specific all-round service: qualification and validation, fast and personal technical support, application consulting and training

Services Tailored for Pharma

Our qualification and validation services ensure your device is up and running quickly and smoothly. They guarantee compliant operation of the instruments and software – fully documented and audit-ready. With our contract modules, you can select what suits your business. No rigid structures, no expenses for unnecessary services. Maintain maximum flexibility while enjoying best customer care and pay only what you need.

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Compliance and Data Integrity

Our user-friendly software solutions for combustion analysis, elemental analysis, and molecular spectroscopy enable analysis in compliance with FDA 21 CFR Part 11. They make data integrity, especially in pharmaceutical quality control, easy and help ensure fast batch approval and process validation within tight production timelines. The software offers the following compliance functions:

  • Centralized data management
  • Role-based access control integrated with Active Directory
  • Robust audit trail functionality
  • Electronic signatures compliant with regulatory requirements
  • Software-guided system suitability tests (SSTs) in accordance with pharmacopoei

Our oftware validation service makes sure that your device is ready to operate in little time.

Intuitive Workflows

To match different user needs in liquid handling, the software provides two interface modes: a powerful, flexible interface for assay setup and optimization, and a simplified, intuitive mode for routine sample preparation.

The interface can be customized to different user levels, enabling easy and intuitive operation in the operational mode.

Solutions at a glance

MethodDevice Special featuresApplication 
TOC/TNmulti N/C 4300 UV
multi N/C 3300 HS
multi N/C 3300
  • Software validation & equipment qualification
    services
  • Software compliance to FDA 21 CFR part 11
  • Supporting last rinse, swab extracts and direct
    swab combustion testing
  • Detection limit as low as 1 μg/L
  • Measurement range from 0 to 10,000 mg/L
  • Cleaning validation
    (USP <643>/<1057>;
    Ph. Eur. 2.2.44, 2.5.33)
TOC
  • Water for injection (WFI)
  • Sterile water (USP <643>)
  • Bulk water
TNmulti N/C 2300
  • Suitable for small sample volumes
  • High automation degree
  • Wide working range
  • Total protein analysis in vaccines
    (USP <1057>)
AASnovAA series
ZEEnit series 
contrAA series 
  • Software compliance to FDA CFR 21 Part 11
  • Variable and automatic sample dilution via
    autosampler
  • Zeeman background correction
  • Transversally heated graphite tube
  • Concentration determination, e.g.
    in electrolyte solutions
  • Raw material testing
  • Glass container/ extractables
    testing (Ph. Eur. 3.2.1)
ICP-MSPlasmaQuant MS series
clinPAL series 
  • Highest sensitivity
  • Unique automated sample handling solution
  • Elemental impurities in
    pharmaceuticals (USP
    <232>/<233>)
  • Trace element detection in clinical
    samples
ICP-OESPlasmaQuant 9200 series
  • Highest resolution on the market
  • LOD in the single digit μg/L range and below
  • Elemental impurities in
    pharmaceuticals (USP
    <232>/<233>)
UV/VisSPECORD PLUS Series 
  • Measurement of 16 samples in one batch
  • Long term stability
  • Dissolution (online/offline)
  • Concentration determination
Automated Liquid Handlers CyBio FeliX
  • Automation under your sterile hood
  • Great cost-to-functionality ratio
  • Cell-based assays
Lab Automation CyBio Well vario series 
  • Precise parallel pipetting in 1536-well format
  • Ready-to-use MALDI Studio software
  • Sample preparation for MALDI 
CyBio Automation
  • Customized automation configurations
  • In-house expertise in precise liquid handling
  • Integration of third party devices 
  • Drug discovery workflows, e.g. ELISA
CyBio Carry
  • Very compact lab robot suitable for limited space
Labware HandelingCyBio QuadPrint series
  • Extremely small footprint
  • Flexible labeling on all four sides of microplates
  • Labware storage, handling and printing
CyBio QuadStack series
  • Different access modules available
  • Two stack height options
qPCRqTOWERiris series 
  • Software compliance to FDA 21 CFR Part 11
  • Highest sensitivity
  • Unique UVA–NIR spectral range
  • Great signal-to-noise ratio
  • Mycoplasma detection
  • DNA/RNA residues
  • Protein thermal shift assay
PCR Biometra thermal cycler series 
  • Calibration service on-site with Biometra TMS
  • Traceability and remote control with Biometra TSuite software
  • Sample preparation for Next Generation Sequencing (NGS)
  • Gene editing

 

E-book: Compliant TOC/TN Analysis in Pharma

In the present e-book, we highlight some of the most common pharmaceutical TOC and TN applications that have been carried out with our new multi N/C x300 analyzers: Ultrapure water testing , TOC cleaning validation, analysis of extractable organic components from packaging materials and quality control of vaccines. We also provide details on how the FDA 21 CFR Part 11 Compliance module of the multiWin pro software supports you to ensure audit-safe and compliant data handling with a server-based central data management.

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Brochure Solutions for Pharmaceutical Industry (EN)

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