Biotechpharma
Biotechpharma, established 2004 and cGMP-certified, is a contract development and manufacturing organisation (CDMO), supporting our clients world-wide. We are offering fully integrated services, thus saving our clients as real one-stop-solution valuable time and money.
Biotechpharma offers cell line construction and process development up to cGMP production of biopharmaceutical products. As a fully vertically integrated CDMO, we are manufacturing additionally drug products in syringes or vials to help our clients to perform their clinical studies and to get all material out of one hand which reduces complexity for the client.
High quality and on time performance is guaranteed by a team of highly qualified and experienced researchers, engineers, technologists and management professionals.
Process Development (PD)
Biotechpharma´s PD- department consists out of 25 R&D laboratories. Our analytical team determines protein purity and structure as well as protein interactions. Biotechpharma develops robust and scalable microbial and mammalian-cell based processes which can be directly transferred to our production-facility for GMP-manufacturing.
cGMP Production
We are executing the projects of our clients in a state-of-the-art facility. Biotechpharma has experts with 15+ years’ experience in biopharmaceutical protein manufacturing.
Biotechpharma´s API manufacturing facility for mammalian cell cultures has one production train up to a 1000 L single use bioreactor with supporting 2, 10, 30 and 200 L seed bioreactors as well as a second production train up to a 2000 L single use bioreactor with supporting 2, 10, 50 and 500 L seed bioreactors. A further single use 200 L-bioreactor is operated in the non-GMP area of our facility.
Furthermore, we are producing microbial-based biopharmaceuticals for our clients in scales up to 300 L working volume.
Our facility includes harvesting and primary recovery areas with appropriate equipment and a downstream processing area with various chromatography columns, skids, TFF systems, stainless steel process mobile tanks and single use bags for processing.
Our Drug product (DP) manufacturing facility has an automatic filling machine for sterile filling into pre-sterilised syringes or vials and all necessary supporting equipment for bulk solution preparation, washing, sterilisation, freeze-drying of vials, capping. The DP manufacturing facility has 2 separate air handling units necessary for performing all operations in grades D, C, B and local A areas.
The clean room and hygiene zone-concept of our facility complies with latest cGMP standards of regulatory agencies. Our team is highly skilled to operate the USP- and DSP-process equipment, and provides continuous support by a deep understanding of biopharmaceutical productions. Our goal is to produce first-time-right and in-time.
Biotechpharma´s master control electronic quality management system ensures process and product compliance at all stages of manufacturing.
Areas of expertise at a glance:
cell line development and GMP-cell banking incl. storage of MCB and WCB
process development of high productivity biosynthesis
efficient downstream process development
drug substance and drug product cGMP manufacturing
cGMP compliant analytical services
process characterisation and validation
stable protein formulation development
stability studies
project management
