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Pharmaceutical Analysis

Pharmaceutical Analysis

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
  • Pharmacovigilance
  • Product lifecycle Management

 

 

News

PHYTOS LPU

8th Food Safety Congress in Berlin

An essential event for the GBA Laboratory Group! This year, the 8th Food Safety Congress will take place in Berlin on June 7th and 8th, 2016. Within the ABION hotel’s event facilities and under the motto “Trust in Food – From the Producer to the Consumer,” numerous technical presentations will be held by renowned speakers from the business and from politics. The event will be rounded out with an interesting selection of workshops dealing with the topic of safety and pro­tection in the food industry. more

INGESA – The International Conference for Grain Production, in Velden, Austria

On June 2nd and 3rd, 2016, for the first time the GBA Laboratory Group will be represented with its own booth (B10) at the INGESA conference, which will be held at the Casino Velden in the town Velden am Wörthersee, Austria. more

Import License for Medicinal Products Granted

The import license for medicinal products acc. to § 72 a, section 1 AMG (German Medicinal Products Act ) and EU regulation 726/2004 was granted to our phar­maceutical laboratory Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG (Neu-Ulm) on March 17, 2016 by the state authorities of Bavaria, Germany (Regierung von Oberbayern, Munich). more