Services for the pharmaceutical industry: GMP support, pharmaceutical contract manufacturing, freeze-drying, HPLC and mass spectrometry
Pharmbiocon GmbH
35080 Bad Endbach · GermanyNew on Amplifa
About Pharmbiocon
Pharmbiocon GmbH, based in Bad Endbach, is a service company for the pharmaceutical and biotechnology industries. With over 20 years of experience in the pharmaceutical industry, the company offers GMP support in the areas of quality management, quality control, and qualification and validation. The portfolio also includes contract manufacturing of pharmaceutical products, including process development, process transfer and process validation, as well as the production of materials for clinical trials. A key focus is pharmaceutical freeze-drying as a contract manufacturing and contract development service; to monitor freeze-drying processes, Pharmbiocon also sells and installs mass spectrometers. In its own BSL II-standard laboratory, the company offers HPLC analysis (including semi-preparative), UV/VIS spectroscopy, microbiology and PCR/qPCR. In addition, the company manufactures Defect Kits (particle sets) for equipment qualification and visual inspection and offers practice-oriented training. The team consists of engineers, chemists, molecular biologists, biotechnologists, and validation and qualification experts.
- Site
- Bad Endbach
- Processes
- Pharmaceutical contract manufacturing (production of pharmaceutical products), Freeze-drying (lyophilization) – contract manufacturing, contract development, process optimization, Mass spectrometry for monitoring freeze-drying processes (sales, setup, installation), UV/VIS spectroscopy (quantitative analysis, purity testing, concentration determination,, HPLC (method development, optimization, validation, analytical separation, semi-preparative, Microbiology (hygiene monitoring, contact plates, swabs, testing of sterilizers and, PCR and qPCR (DNA detection/amplification, cell type identification, DNA profiles,, Manufacture of Defect Kits (particle sets) for equipment qualification and visual inspection
- Materials
- Vials (pharmaceutical glass for Defect Kits), Freeze-drying (Lyophilization), High-performance liquid chromatography (HPLC), UV/VIS Spectroscopy, Mass Spectrometry, PCR and qPCR, Microbiology, Vials (Pharmaceutical Glass)
- Certificates
- GMP, BSL II laboratory
- Industries
- Pharmaceutical industry, Biotechnology, Life Sciences
- 01
GMP support and qualification/validation
- 02
Process development and process transfer
- 03
Pharmaceutical contract manufacturing
- 04
Freeze-drying (lyophilization)
- 05
Analytics (HPLC, UV/VIS, microbiology, PCR)
- 06
Documentation and method validation
- 07
Training and Defect Kits
Processes and Analytics
Freeze-drying (Lyophilization)
Contract manufacturing, contract development and process optimization for pharmaceutical freeze-drying processes.
High-performance liquid chromatography (HPLC)
Method development, optimization and validation as well as analytical and semi-preparative separation of substances.
UV/VIS Spectroscopy
Double-beam photometry with split-beam technology for quantitative analysis, purity and concentration determination as well as trace analysis.
Mass Spectrometry
Sales and on-site installation of mass spectrometers for seamless monitoring of freeze-drying processes in accordance with EU GMP Annex 1.
PCR and qPCR
Detection and amplification of DNA, cell type identification and support with RNAi validation.
Microbiology
Hygiene testing using contact plates and swabs, e.g. for testing sterilizers and disinfection equipment.
Vials (Pharmaceutical Glass)
Used in Defect Kits (particle sets) for equipment qualification, training and visual inspection.
Locations
Bad Endbach
DEHeadquarters, laboratory (BSL II), contract freeze-drying
- Materials
- pharmaceutical products, vials
- HPLC system (analytical and semi-preparative)
- UV/VIS double-beam photometer (split-beam technology)
- Freeze-drying system (contract manufacturing)
- BSL II laboratory
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Pharmaceutical contract manufacturing (production of pharmaceutical products)Assembly | – | – | – | – | pharmaceutical products |
| Freeze-drying (lyophilization) – contract manufacturing, contract development, process optimizationEngineering | – | – | – | – | pharmaceutical products |
| Mass spectrometry for monitoring freeze-drying processes (sales, setup, installation)Testing | – | – | – | – | – |
| UV/VIS spectroscopy (quantitative analysis, purity testing, concentration determination,Testing | – | – | – | – | – |
| HPLC (method development, optimization, validation, analytical separation, semi-preparativeTesting | – | – | – | – | substances |
| Microbiology (hygiene monitoring, contact plates, swabs, testing of sterilizers andTesting | – | – | – | – | – |
| PCR and qPCR (DNA detection/amplification, cell type identification, DNA profiles,Testing | – | – | – | – | – |
| Manufacture of Defect Kits (particle sets) for equipment qualification and visual inspectionAssembly | – | – | – | – | vials |
| Process transfer, process development, optimization, scale-up, process validation, production ofEngineering | – | – | – | – | pharmaceutical products |
| Method transfer, method validation, analysis support, technical documentationTesting | – | – | – | – | – |
| GMP service: quality management, eQM systems, audit support, SOP creation, GMP project managementEngineering | – | – | – | – | – |
| Qualification/requalification of equipment and systems (small to large-scale equipment), FAT and PQTesting | – | – | – | – | – |
| Process and method development in the company's own BSL II laboratory (small scale)Engineering | – | – | – | – | – |
| Professional training/courses (GMP, freeze-drying, laboratory work, mass spectrometry)Engineering | – | – | – | – | – |
5 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| HPLC system | – | – | analytical and semi-preparative | – | Bad Endbach |
| UV/VIS spectrometer (double-beam photometer, split-beam technology) | – | – | – | – | Bad Endbach (in-house laboratory) |
| Freeze-drying system (contract manufacturing) | – | – | – | – | Bad Endbach |
| Mass spectrometer (sales, setup, installation) | – | – | Freeze-drying monitoring | – | – |
| BSL II laboratory | – | – | – | – | Bad Endbach |
Additional services
Quality
Pharmbiocon operates in accordance with Good Manufacturing Practice (GMP) requirements and supports customers with process and method validation, including all required documents. Process and method development takes place in the company's own BSL II laboratory.
| Evidence | Bad Endbach |
|---|---|
| GMP | |
| BSL II laboratory |