Our location for pharmaceutical analysis supports you in the development, approval process, and quality control of your products with an extensive range of services
The pharmaceutical division of the GBA Laboratory Group consists of two companies, LPU Labor für Pharma- und Umweltanalytik GmbH (located in Martinsried and Gräfelfing) as well as Phytos Labor für Arzneimittelanalytik GmbH & Co. KG (located in Neu-Ulm).
Our subsidiaries can draw upon decades of experience in pharmaceutical analysis and supporting pharmaceutical approval processes in the fields of human and veterinary medicine. Over this time period, they have been able to build up a global customer base through reliable and faithful cooperation.
As an analytical “one-stop shop” operating under cGMP, the GBA Laboratory Group’s pharmaceutical division offers scientific and technical solutions for domestic and international customers, from both the private industry and research institutions, for the development, approval process, and quality control during every step in the product lifecycle.
With a comprehensive range of services in the analytical and regulatory fields, we can offer fast, flexible, and customer-oriented solutions.
Take advantage of our competent all-around service, all from one source!
- Method development, validation, and transfer
- Quality control (customer-specific testing instructions, Ph.Eur., USP, BP, JP, PPRC)
- Stability studies (e.g. ICH, VICH) and sample storage management
- Qualification, establishment, and management of reference standards (e.g. primary standards and working standards)
- EU gate analysis
- Releasing human and veterinary pharmaceuticals for marketing authorization (par. §13.1, QP service)
- Release of clinical investigational products (QP service)
- Residue and trace analyses (e.g. elemental impurities [ICH Q3D], genotoxic impurities)
- Registration services (e.g. eCTD, all authorization processes)
- R&D under GMP and non-GMP standard
Our core competencies and special expertise consist of the following fields:
- Amino acid analyses (e.g. testing for Ninhydrin-positive substances)
- Analysis of antibiotics
- Analysis of substances without chromophore (e.g. using LC-ELSD, LC-CAD, LC-RI)
- Support during the downstream processing by testing for small molecules (e.g. methotrexate, aminoglycoside antibiotics, polysorbates, simethicone, poloxamers, Triton X 100) in biotechnologically generated pharmaceuticals
- Trace analysis of beta-propiolactone in vaccines
- Elemental analysis (AAS, ICP-OES, ICP-MS)
- Extractables & leachables studies
- Genotoxic impurities
- Determination of residual solvents Dissolution rate testing (USP I, II, IV)
- Identification of impurities (LC-MS, GC-MS)
- Capillary electrophoresis (e.g. capillary zone electrophoresis, CZE, micellar electrokinetic chromatography, MEKC, sodium dodecyl sulfate-polyacrylamide gel electrophoresis, SDS-PAGE)
- Microbiological tests (ICH harmonized purity methods, determination of antibiotics and vitamin values, drinking water testing including sampling)
- Microbiological hygiene monitoring (contact sampling, sediment samples, air samples, testing of water for pharmaceutical use)
- MS coupling techniques (e.g. GC-MS, LC-MS, including LC-MS-Q-ToF)
- Protein analysis (e.g. erythropoietin: EPO, insulin, antibodies)
- Quality control of primary packaging material (glass, plastic), including leak testing
- Testing of highly potent substances (e.g. cytostatic pharmaceuticals) and photolabile compounds
Furthermore, in addition to scientific and strategic pharmaceutical consulting, our know-how includes an extensive range in the field of regulatory affairs, for example:
- Carrying out authorization processes and registrations (CP, DCP, MRP, NP)
- Creating dossiers, technical documents (CTD, eCTD, IMPD, NTA, STED, etc.)
- Scientific advice
- Variation & line extensions
- Product lifecycle Management