Address: Alt Fechenheim 34, D-60437 Frankfurt am Main, Germany
Tel: +49 (0)69 4109 2534
Fax: +49 (0)69 4269 4784

Prolytic GmbH

Prolytic GmbH is a contract research organization (CRO) who are experts in bioanalysis and pharmacokinetics. The company offers particular expertise and capabilities in bioanalysis, pharmacokinetic evaluations and specific pharmaceutical analysis under GLP and GCP.

Prolytic’s mission is to support its pharmaceutical and biotech partners in drug development with best quality analytical services for companies especially for pre-clinical, clinical and toxicokinetic studies, bioanalysis, competent advice, and absolute quality assurance.

It provides clients with a range of sophisticated services that cover development and validation of testing procedures, methods and processes, examining complex sample mixtures as well as pre-clinical and clinical study samples. Prolytic can also conduct compartmental and non-compartmental pharmacokinetic evaluations with analysis and quantification of small molecules, proteins, antibodies & antigens, ADAs (anti-drug antibodies), biomarkers & biosimilars and determination of enzyme activity.

Services

Prolytic operates in three principal business segments, bioanalysis, pharmacokinetics and pharmaceutical analysis.

Bioanalysis

As an independent GLP/GCP testing laboratory, Prolytic can analyse biological samples delivered mainly from pre-clinical and clinical studies to detect small and large molecules as well as biomarkers.

To this end, Prolytic has developed and validated analytical methods according to the latest medicinal and veterinary medicinal guidelines and using state of the art equipment (see Technologies).

Prolytic can undertake qualitative or quantitative drug and metabolite analyses in blood, plasma, urine, tissue or other biological matrices.

Bioanalytic services also include In-vitro investigations for distribution coefficient, protein binding, metabolism, stability and molecular weight.

Bioanalytic services typically follow a three layer structure that comprise:

  • Quantification of small molecules via HPLC – UV-Vis / ECD (electrochemical detection) and FD (fluorescence detection). As source options, Prolytic can offer LC – MS/MS with ESI (electrospray-ionization) or APCI (atmospheric pressure chemical ionization).
  • Quantification of proteins, antibodies, antigens, ADAs (anti-drug antibodies), biomarkers or biosimilars; using ELISA – absorption / fluorescence / luminescence assays or RIA (radioimmunoassay).
  • Determineenzyme activity through again ELISA (enzyme-linked immunosorbent assay) analysis of absorption, fluorescence and luminescence, as well as RIA (radioimmunoassay) gamma counter.
Pharmacokinetics

Prolytic’s pharmacokinetics service begins with consultation during the preparatory stage of a study, supporting partners in the planning of both pre-clinical and clinical studies considering study design and other pharmacokinetic parameters.

Pharmacokinetic non-compartmental and compartmental evaluations include PK/PD modeling and optimization of dosing schedules. Evaluations are conducted using Phoenix® WinNonLin software, with documentation delivered according to the existing FDA/EMA guidelines.

Toxicokinetic studies include study planning within defined preclinical range, project preparation and project coordination, leading to expert reports covering validation, analytical, pharmacokinetic and toxicokinetic aspects.

Technologies

Prolytic has constantly expanded and modernized its equipment in the past years in order to be able to provide their clients with highest quality service and fastest processing of assignments. The Prolytic laboratory in Frankfurt operates high-performance liquid chromatography (HPLC-) systems with different detectors, along with two online Spark Holland Symbiosis SPE (serum protein electrophoresis) systems.

  • HPLC Coulometric detector
  • Amperiometric detectors
  • Fluorescence detectors
  • DAD-Detectors
  • UV/Vis-Detectors
  • Applied Biosystems API 4000 MS/MS Detectors

Its immunological test systems include RIA- gamma counter, ELISA-Microtiter-Reader (UV/Vis) and Microplate Synergy (Luminescence, Fluorescence, Visible).

In addition to generic data evaluation software, Prolytic operates highly sophisticated software for specialist data processing. This includes:

  • Parallel Line Assay (PLA) Software 3.0 from Stegmann Systems, used to calculate the relative potency of a dilution assay and aid configuration optimization in identifying acceptable regions of the dose–response curve
  • Pharsight Corporation’s Phoenix® WinNonLin Software 7.0

Structure and history

Prolytic was founded in December 2002 by a group of experienced scientists as a management buy-out of the Viatris KG (formerly ASTA Medica) Drug Development Center.

The team, headed by Dr. Dorothee Krone and Peter Romeis, founded Prolytic to provide bioanalytical and pharmacokinetic services to pharmaceutical and biotech companies.

The company’s initial operations, from January 2003, were based in the AllessaChemie industrial park at Frankfurt-Fechenheim.

Prolytic swiftly obtained authorization to work with radioactive 125Iodine (30 MBq) as well GLP certification. By 2008 the company had also achieved full GMP certification.

The total Prolytic team now approaches 15 people, covering a wide range of specialist disciplines.

Prolytic is now planning relocation to a new purpose-built facility that will remain close to Frankfurt, in the heart of Germany.

Quality and Regulatory

Prolytic’s operations are Good Laboratory Practice (GLP) certified and the company also works in compliance with Good clinical Practice (GCP).

As formal head of test facilities, Managing director and founding partner Dr. Dorothee Krone heads a GLP organizational and reporting structure that includes IT, formal GLP Quality Assurance (QA), Bioanalytics & Pharmacokinetics and GLP Activities.

Quality assurance is assured through a rigorous internal handbook and Standard Operating Procedures (SOPs).

To deliver best quality is Prolytic`s highest priority and is very much appreciated by its customers.

Contact

To learn more about Prolytic’s services and capabilities and how they can assist your business, please contact the supplier.



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