Contract Development Biopharmaceuticals
Polymun offers the establishment of biopharmaceuticals all the way from the gene to clinical grade material for innovator and biosimilar products. We regard vector, production cell line, processes for fermentation and purification as well as specific analytics as parts of a networked development in order to achieve optimal application for industrial implementation.
Polymun has long term experience in converting scientific approaches for new biopharmaceuticals into industrial processes. Examples from Polymun′s own R&D projects are the HIV antibodies for mammalian cell culture or superoxide dismutase (SOD) for microbial cell culture. All steps described below are embedded in a comprehensive system of documentation and quality necessary for clinical evaluation. Based on Polymun′s own experience it is able to provide support for planning clinical trials phase I-III. Transfer of the process to the client is achieved by coherent GMP documentation and on-site training of key personnel. Polymun especially offers technology packages for CHO cells, hybridomas, tissue culture for viral vaccines, E. coli and for yeasts.Polymun is establishing production processes for two recombinant human hormones: human growth hormone (hGH) and luteinizing hormone (LH). We are open for co-operations for further development of these products.
For Finox AG, Polymun developed a manufacturing process for recombinant human follicle-stimulating hormone (rhFSH) as biosimilar. A phase I study was completed successfully with GMP material manufactured by Polymun, the phase III study is ongoing.
An agreement has been signed with GeNeuro SA, Switzerland,
for the cell line development and GMP-compliant manufacturing of a monoclonal antibody for the treatment of multiple sclerosis.
Polymun has signed a contract manufacturing agreement with Apeiron Biologics
for its lead project APN01.
A GMP production process was established for the recombinant human soluble ACE2 in CHO cells. Clinical
development was started with the GMP material manufactured by Polymun.
After the APN01 project of Apeiron was assigned to GlaxoSmithKline, GSK contracted Polymun for further process development and manufacturing of clinical trial supply.
Polymun is contract manufacturer of a recombinant gp140 HIV envelope protein for
St George's, University of London in the context of a project of the
Grand Challenges in Global Health.
This Mucosal HIV Vaccine Project under the lead of Dr. Robin Shattock is focusing
on novel antigen design and delivery for mucosal protection against HIV-1 infection.
Polymun has developed a CHO cell line as well as fermentation and purification processes for the production of recombinant
human erythropoietin (EPO). Six consecutive industrial batches have been manufactured under GMP conditions. Phase
I studies were performed successfully in Austria. Polymun is free to sell EPO and to market the manufacturing technology.
Polymun established a CHO production cell line for the chimeric monoclonal antibody ch14.18 and repeatedly manufactured
GMP-compliant material for a European-wide clinical study for the
treatment of neuroblastoma. This study is under the chair of Dr. Ruth Ladenstein,
St. Anna Children's Hospital, Children's Cancer Research Institute.
Vector Construction
Next to optimal production premises, the absence of third party IP-rights is an important criterion.Establishment of Production Clones and Cell Banks
Of equal importance are high and stable productivity as well as favorable growth properties in low cost cell culture media free of proteins and animal-derived components. For the screening we resort to our wide range of analytical tools. Polymun has two separate GMP-laboratories for establishing master and working cell banks. Cell bank qualification is performed in collaboration with certified QC-laboratories.Process Development for Fermentation
An appropriate process is selected from a choice of batch, fed-batch, continuous and continuous perfused high cell density systems. The reactor types used are stirred tank, air-lift and fluidized bed. For perfusion various systems for cell retention are available including different types of microcarrier and ultrasonic devices. The medium is adjusted for the individual production clones. Medium concentrates are rebalanced for fed-batch applications in order to meet the metabolic requirements of the particular clone. Scalability and robustness are of high priority.Development for Downstream Processing
Downstream process development is a strong technology platform of Polymun. We aim to compose a process from a broad spectrum of methods that is optimal in terms of yield, product purity, virus clearance but also scalable and inexpensive. The transfer from lab through pilot scale to industrial scale is given special consideration due to our experience in manufacturing. Polymun uses a standard purification scheme for antibodies. This scheme is applied routinely e.g. for our HIV antibodies which have been under clinical evaluation under IND of the FDA.Production of Preclinical and Clinical Material
Initial amounts of protein can be produced in the lab scale at an early stage for preclinical evaluation.
GMP-compliant material is manufactured in our pilot plant for the clinical evaluation.