| What products does Diosynth Biotechnology manufacture? |
| Diosynth Biotechnology manufactures recombinant proteins/peptides and DNA products for therapeutic and vaccine applications. We have expertise with a wide range of proteins including monoclonal antibodies, fusion proteins, hormones, anti-coagulants, cancer vaccines, glycosylated and non-glycoslated products. |
| What cGMP biomanufacturing services does Diosynth Biotechnology offer? |
| Diosynth Biotechnology is a full service manufacturer of recombinant human therapeutic proteins and monoclonal antibodies for the pharmaceutical and biotechnology industries. Diosynth Biotechnology is a market-driven and technology-based contract manufacturing organization that has world leading expertise in the development, refinement and technology transfer of cGMP manufacturing processes. Our scale-up, cGMP manufacturing and validation services support pre-clinical, clinical and commercial production. From cell line development to delivery of fully tested cGMP bulk purified product, Diosynth Biotechnology supports its customers with a full range of quality services. |
| What process development services does Diosynth Biotechnology offer? |
| Diosynth Biotechnology has an extensive Process Development department which is highly experienced in the development of processes as appropriate for early or late stage drug development. We are experts in assembling robust, scaleable unit operations and processes. We employ scientific excellence and maintain an extensive knowledge of global regulations. We have years of experience in the efficient operation of biopharmaceutical production facilities to develop processes that are cGMP compatible and cost-effective. We have applied our services across numerous expression systems and many classes of recombinant molecules. The range of process development services provided includes: fermentation/cell culture, recovery, purification and a comprehensive range of analytical development services. We also offer formulation development and stability studies. |
| What expression systems does Diosynth Biotechnology have experience with? |
| We offer services in support of both cell culture and microbial expression systems. We have experience with a very wide range of cell types including the most commonly used mammalian systems such as CHO, NS0 and hybridomas and bacterial systems such as E. coli. In addition, we have developed world-leading expertise in production from yeast systems such as Pichia pastoris and also offer production from Baculovirus systems. |
| What scale and type of cGMP production does Diosynth Biotechnology provide? |
| Diosynth Biotechnology provides fed-batch and perfusion technology for both cell culture and microbial production. Our U.S. facilities offer a wide range of capacities for both cell culture and microbial fermentation up to 2,000-L (total volume) scale and our European facilities feature cell culture capacity up to 18,000-L and microbial fermentation to 10,000-L scale (working volume). |
| Does Diosynth Biotechnology manufacture commercial product? |
| Yes. Diosynth Biotechnology manufactures products that are marketed in the US and Europe for a range of customers. |
| Will Diosynth Biotechnology be able to meet my requirements in the future? |
| Yes. Diosynth Biotechnology is a highly experienced manufacturing company and understands the essential need for a secure supply of product for both clinical and commercial supply. We will strive to be your supplier-of-choice by working closely with you to understand your long-term needs and to plan accordingly. |
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