GBA Group Pharma

About GBA Group Pharma

GBA GROUP PHARMA - Your Experts for Pharmaceutical Analytics and Solutions. With a wide range of services, GBA GROUP PHARMA offers Individual Support Throughout all Stages of Pharmaceutical Product Life Cycle.

  • GBA GROUP PHARMA is a leading provider for Analytical and Consulting Services worldwide with six sites under one roof
  • The GBA PHARMA LABS run three GMP-Certified and FDA-Inspected Sites in Germany with more than 160 highly qualified employees and over 4,500 m2 of lab space  
  • Three more sites under the GBA GROUP PHARMA roof are represented by ABF Pharmaceutical Services (Vienna, Austria) providing Clinical Trial Supply ManagementLKF (Kiel, Germany) offering Central Laboratory Services, as well as Pharmacelsus (Saarbruecken, Germany) providing Preclinical Drug Discovery and Development Testing incl. In-Vitro GLP/non-GLP Bioanalysis
With a Long-Term Expertise of Over 30 Years in the pharmaceutical business, GBA PHARMA LABS provide fast, flexible, and customer-oriented solutions including:
  • Method Development, Validation and Transfer 
  • Quality Control of Raw Materials, Excipients, APIs and Finished Products according to Customer-Specific Test Methods or Pharmacopoeia Monographs, e.g. Ph.Eur., USP, JP
  • Amino Acid Analysis Testing according Ph.Eur 2.2.56 Method 1 (currently 14 amino acids verified and established in routine testing)
  • Stability Studies (e.g. ICH, VICH) and Sample Storage Management
  • EU Retest
  • Release of Human and Veterinary Pharmaceuticals for Marketing Authorization (par. §13.1, QP Service)
  • Release of Clinical Investigational Products (QP Service)
  • Residue and Trace Analyses
  • Analysis of Elemental Impurities, USP <232>, <233>, ICH Q3D and Metal Testing
  • Extractables & Leachables (E&L) Studies
  • Visible Particles, Subvisible Particles, Particles Size Distribution according Ph.Eur., USP and JP
  • Microbiological Examinations
  • Registration Services (e.g. eCTD, all Authorization Processes)
  • Analysis of Large Molecules, e.g. NBEs and Biosimilars
  • R&D under GMP and Non-GMP Standard
  • Consulting on all Aspects of Analysis, Regulatory Affairs and Pharmaceutical Strategy

  • DE
  • 2015
    On CPhI since
Contact info

Products from GBA Group Pharma

  • Quality Control

    Product Quality Control

    GBA Pharma provides wide range of pharmaceutical analysis services which includes Quality Control. It includes: Testing of packaging materials; Implementation of analytical methods including transfer, monitoring and reporting; Testing of semi-finished goods; Testing of small scale batches and batches from development (from phase 1 to market). Contact us for more information.
  • Method Development and Validation

    Product Method Development and Validation

    GBA Gesellschaft für Bioanalytik mbH provides wide range of pharmaceutical analysis services which includes Method Development and Validation. The development and validation of a new method often seems to be hard and complex. Prior to the start, a lot of facts have to be considered. Beneath the availability of qualified personal the performance of the new method has to meet internal and general quality guidelines and should be suitable for everyday use. Especially with biotherapeutics, you are forced to follow new analytical paths, as new synthetic pathways are explored continuously.. Contact us for more information.
  • EU Import & QP Services

    Product EU Import & QP Services

    EU QP release
    QP declaration
    IMP release
    Quality advisor GMP, GCP, GDP, GLP
    GMP consulting Audits of CMOs
    Preparation / revision of batch records & SOPs
    QP backup services
  • Biotech Products

    Product Biotech Products

    Method development and validation according to ICH guidelines
    Peptide/protein sequencing and sequence coverage
    Amino acid Analysis of ninhydrine-positive substances
    Analysis of glycans by HILIC-LC-MS
    Analysis of proteinogenic APIs by HPLC-MS-QToF
    Posttranslational modifications
    Microbiological testing and endotoxines
    Elemental Impurities by AAS/ICP-OES/ICP-MS
    Residual solvents by HS-GC
    Stability storage (ICH-conditions, -80°C and customer related conditions e.g. 30°C/35% r.h.)
  • IMP Handling Services

    Product IMP Handling Services

    Licensed to import & export IMPs
    Controlled production facilities (primary & secondary packaging)
    GMP compliant controlled warehouse
    Blinding and comparator sourcing
    Recalls, randomization,  emergency envelopes
    Return, drug accountability and destruction
    Labeling, relabeling, and packaging according to GMP guidelines
  • Stability Testing and Storage

    Product Stability Testing and Storage

    GBA Pharma provides wide range of pharmaceutical analysis services which includes Stability Testing and Storage. The services include: Advice and assistance in the planning of stability studies; Development of stability plans; Conducting stability studies (exploratory, confirmatory, ongoing, follow-up); Implementation of dawn rates (freeze-thaw); Stress tests (stability indicating); Photostability testing . Contact us for more information.
  • Preclinical testing in vivo

    Product Preclinical testing in vivo

    We plan, organise and realise customised preclinical studies for life science companies and academic institutions. For more than 15 years 120+ satisfied customers rely on our expertise, our experience and particularly on our passion for quality.

  • In vitro & In vivo Toxicology Services

    Product In vitro & In vivo Toxicology Services

    The Pharmacelsus service portfolio on in vitro and in vivo toxicology offers you a complete workflow to de-risk either your early stage drug discovery or late stage development programs. In vitro toxicology assays are performed in-house in a quality controlled way. In vivo toxicology studies according to national and international guidelines are available on rodent and non-rodent species in cooperation with our trusted partner.

    In vitro Toxicology Cytotoxicity
    • Test systems
      Established cell lines and primary cells, 2D– monolayer, suspension and 3D-organoid cultures
    • Analysis
      Fluorescence, luminescence, absorbance
    • Indicator
      Resazurin, XTT, MTT, ATP, LDH, TMRE, neutral red
    • Readout
      Viability, Mitochondrial Membrane Potential
    Mitochondrial Toxicity
    • Test systems
      HepG2, HepG2-Oxphos
    • Analysis
      Fluorescence, luminescence
    • Indicator
      Resazurin, XTT, ATP, TMRE, JC-10
    • Readout
      Mitochondrial Membrane Potential
    • Format
      96-Well Plate/Plate Reader
    • Multiplexing of analytical endpoints available
    Metabolite Toxicity
    • Test systems
      HepG2 w/ and w/o metabolic activation by S9-fraction
    • Analysis
      Luminescence
    • Indicator
      ATP
    • Format
      96-Well Plate/Plate Reader
    • Metabolite identification via LC-MS
    Immunotoxicity
    • Test systems
      PMBC, monocytes, blood
    • Analysis
      Luminex technology
    • Readout
      Lymphocyte subsets, cytokine levels
    • Format
      96-Well Plate/Plate Reader, Luminex
    • Can be combined with other systems e.g. viability assays
    • Recommended assays according to ICH S8
    Hepatotoxicity
    • Test systems
      HepG2, primary hepatocytes
    • Analysis
      Fluorescence, luminescence
    • Indicator
      Resazurin, ATP
    • Readout
      Viability
    • Format
      96-Well Plate/Plate Reader
    • Multiplexing of analytical endpoints available
    Mutagenicity/ Genotoxicity
    • Ames test*
    • Ames MPFTM Penta I
    • Chromsomen aberration (human lymphocytes)*
    • Mouse lymphoma assay*
    • HPRT*
    • Micronucleus (human lymphocytes)*
    • *in cooperation. All studies are conducted according to national and international guidelines

    Allergic Response
    • Test systems
      Peritoneal mastocytes
    • Analysis
      Absorption
    • Indicator
      O-phtaldialdehyde
    • Readout
      Histamine release
    • Format
      96-Well Plate/Plate Reader
    Skin/ Eye*
    • Skin corrosion (EpiDerm, Corrositex®)
    • Skin irritation (EpiDerm)
    • Skin sensitization (DPRA, LuSens)
    • Eye corrosion and irritation (BCOP, EIT, HET CAM)
    • *in cooperation. All studies are conducted according to national and international guidelines



  • In vitro ADME Services

    Product In vitro ADME Services

     The in vitro ADME team of Pharmacelsus combines professionalism of the pharmaceutical industry with the flexibility to adapt standard assays for specific requirements. We support your projects in setting up your studies to meet regulatory requirements.

    Evaluate the “druggability” of your compounds by the following set of in vitro ADME assays.

    Physico-chemical Parameters
    • Storage
    • Chemical stability
    • Lipophilicity
    • Aqueous solubility
    Stability in Biological Matrices
    • Blood
    • Plasma
    • Intestinal fluids
    • Further matrices on request
    Membrane Permeability
    • PAMPA
    • Artificial BBB
    • Bidirectional Caco2
    • Nuclear uptake
    • PgP interaction
    Interaction with Drug Transporters
    • ABC-ATP binding
    • SLC transporters* (inhibition/uptake)
    Protein Binding Mechanism
    • PPB
    • SPB
    • Blood partitioning
    • Kd (HSA, AGP)
    • Microsomal binding
    Brain Tissue Binding
    • Rat, mice tissue
    • Ultrafiltration
    Metabolic Stability
    • Liver microsomes
    • S9
    • Hepatocytes
    • UGT profiling
    Reactive Metabolite Trapping
    • Liver microsomes
    • GSH
    • SCZ
    • Orbitrap technology
    Metabolite Identification
    • Liver microsomes
    • S9
    • Hepatocytes
    • Orbitrap technology
    • Metabolic pathway
    • Metabolite abundance
    CYP Inhibition
    • Liver microsomes
    • Hepatocytes
    • Recombinant human CYPs
    • Mode of inhibition, inhibition kinetics
    CYP Induction
    • 2D & 3D human hepatocytes
    • Hepa RG®
    • Functional activity
    • mRNA

    CYP Phenotyping
    • Recombinant human CYPs
    • Loss of parent compound
    • Clint
    • Half-life
  • Regulatory Affairs

    Product Regulatory Affairs

    GBA Pharma provides wide range of pharmaceutical analysis services which includes Regulatory Affairs. Their services includes: Regulatory Affairs within all application forms as well as MAA procedures; Risk assessments acc. to ICH Q3D; Readability User Test for Patient Information Leaflets; Pharmacovigilance; Plant-Based Medicines. Contact us for more information.
  • IMP Manufacturing

    Product IMP Manufacturing

    Outer Packaging, Blinding and comparator sourcing
    Customized labels: Country specific text design, translation & GMP printing of labels
    Single panel labels, Multi language labels, Booklet, Tear off labels, Wrap labels
    Authorized & controlled production facilities for primary & secondary packaging
    Labelling, relabelling & packaging according to GMP guidelines
    Labelling at ambient temperature, +2°C(35.6 °F) to +8°C(46.4°F), -20°C(-4°F) and dry ice
    Recalls, Blinding, Randomization, Emergency envelopes
    Return for drug accountability and destruction (including certificate)

  • In vivo DMPK Services

    Product In vivo DMPK Services

    Flexibility in study design and meeting demanding time lines is the strength of the Pharmacelsus in vivo team. We offer DMPK studies in mice, rats, guinea pigs and hamsters. Further preclinically relevant species (e.g. dog, monkey) are available in cooperation with our partners. The Pharmacelsus offering includes complete workflow studies (in-life part, bioanalysis and PK evaluation).

    Species
    • Rat
    • Mouse
    • Guinea pig
    • Hamster
    • Dog*
    • Monkey*
    • *in cooperation

    Application Routes
    • Intravenous (bolus or infusion)
    • Oral (liquid, capsules)
    • Intraperitoneal
    • Subcutaneous (incl. osmotic minipumps)
    • Intramuscular
    • Intradermal
    • Intranasal
    • Topical
    • Intravitreal
    • Intraportal
    • Single, repeated and cassette dosing
    Surgical Methods
    • Cannulation (rat)
      • vena jugularis (neck or head attachment)
      • portal vein (e.g. for evaluation of first-pass effect)
      • bile duct (e.g. for evaluation of entero-hepatic circulation)
    • Bile duct ligation (rat)
    • Ureter ligation (mouse, rat)
    • Castration
    Sampling Methods
    • Jugular catheter
    • Tail vein or artery
    • Sublingual vein
    • Plexus retrobulbaris
    • Heart puncture (terminal)
    • Dried blood spots (microsampling)
    • Tissue perfusion
    • Metabolic cage
    Sample Types
    • Whole blood, plasma, dried blood spots
    • Excreta
      • urine
      • faeces
      • bile
    • Cerebrospinal fluid
    • Tissues/organs
    Biomarkers
    • All markers that can be quantified in biological matrices by validated immuno-assay or LC-MS-methods
    • Sample processing for histology
    • Haematology, flow cytometry
    Exploratory PK Studies
    • Dried bloodspot / snapshot PK
    • Cassette dosing
    • Major metabolites
    Full PK Studies
    • Dose proportionality
    • Organ distribution, excretion, mass balance
    • Metabolite identification
    • First pass effect

GBA Group Pharma Resources

  • Brochure GBA Group Pharma: Fields of Expertise (Short Overview)

    GBA Group Pharma supports throughout the entire lifecycle of a drug - from early lead optimization and preclinical stage to clinical phases and market release. GBA Group Pharma is a fully Brexit proof organisation.
  • Brochure GMP Release Testing of Biopharmaceuticals (Flyer)

    GMP release testing of drug substances and drug products is essential to ensure the quality of biopharmaceuticals, i.e. drugs that are based on large molecules, usually of biotechnological origin. Our service range consists of specific sets of analytical tests and assays, addressing product characteristics like identity, purity, protein content and safety.
  • Brochure Characterization of Biopharmaceuticals (Flyer)

    Comprehensive structural and physicochemical characterization of biopharmaceuticals requires the application of a wide range of analytical principles and methods. Therefor PHARMACELSUS GmbH utilizes a broad spectrum of state-of-the-art instrumentation and thereby putting a strong accent on mass spectrometry (e.g. Orbitrap).

  • Brochure GBA Pharma Company Presentation (Slide Deck)

    GBA Pharma is a service provider for pharmaceutical companies and is supporting research & development as well as services in the commercial stage.
    Our success and opportunities is based on a high qualified staff. The headcount of GBA Pharma represents 200 employees distributed over 5 locations in Europe with +50% academic staff.
    Our portfolio comprises the following service areas:
    o   Contract research in the preclinical arena (in vitro & in vivo)
    o   Pharmaceutical testing under GMP incl. stability study services & QP release services
    o   Bioanalysis under GLP: in vivo toxicology studies and phase-I/II clinical studies
    o   GMP qualification of API and drug manufacturer outside the European Union
    o   Distribution and clinical trial supply management for multicentre trials
    o   Consultancy & regulatory af...