Fujifilm Diosynth Biotechnologies (FDB) is a global contract development and manufacturing organization (CDMO) with over 25 years of experience in process development and/or manufacturing of greater than 310 molecules at sites in: Billingham, England; Research Triangle Park, North Carolina; and College Station, Texas. At our College Station location, we specialize in the development and manufacture of virus-based vaccines (attenuated or recombinant viruses), oncolytic viral therapies (such as adenovirus, polio) and gene therapy vectors (such as adeno-associated virus [AAV])…
Tag: <span>serum-free media</span>
A rapid increase in the number of gene therapy trials and products has led to a comparable increase in the need for industrial production of viral gene therapy vectors such as lentiviral, adeno-associated, and adenoviral vectors. Current production systems are limited with respect to scalability and robustness. With our CAPĀ® and CAP-Tā¢ cell lines, we have developed a novel system for high-density suspension culture, efficient and reproducible transfection, and highly efficient production of viral vectors. By upstream process optimization, we have obtained a robust and high-density fed-batch culture system which can be scaled in any current bioreactor format. A design-of-experiments approach has been employed to optimize transient production of lentiviral vectors with significantly higher titers than can be obtained with adherent HEK293T cells…
The biopharmaceutical industry has seen a major shift away from the use of serum and other animal-derived components in the manufacture of biopharmaceuticals.Ā Guidance from the EMEA and FDA for the manufacture of biopharmaceuticals and medical devices encourages the use of “animal free” components to lessen concerns over contamination from adventitious agents such as prions, a cause of spongiform encephalopathyā¦
With the continued growth of the biopharmaceutical market, the cell culture industry has seen a major shift away from the use of serum and other animal-derived supplements in the manufacture of biopharmaceuticals. Indeed, supporting guidance from the EMEA and FDA for the manufacture of biopharmaceuticals and medical devices encourages the use of “animal-free” components.Ā The key driver for this can be attributed to the increased concern with contamination from adventitious agents such as transmissible encephalopathiesā¦
Baculovirus infection of insect cells is an established method to obtain large quantities of biologically active recombinant proteins with properties similar to those of proteins expressed in mammalian cells. Insect cells are capable of most mammalian posttranslational modifications that control protein compartmentalization, secretion, targeting to nucleus or cell surface, N- and O-glycosylation, phosphorylation, proteolytic processing, and assembly of multi-protein complexes. The baculovirus transfer plasmids and accessory products utilized for protein expression in insect cells are currently available from several commercial sources. The plasmids often contain his-tags to facilitate Ni-NTA purification of recombinant proteins, and/or signal peptides to promote or enhance secretion of the proteins into the medium. Typically, in most baculovirus cloning vectors the coding region of the polyhedrin gene has been replaced by a polylinker with multiple cloning sites for the insertion of the cDNA of interest downstream of the strong polyhedrin promoterā¦
Parvoviruses are one of the most prevalent infectious agents in the laboratory rodent. Their effect on research can range from immune dysfunction that may mislead researchers when interpreting results to lethal effects on animals. Until recently parvovirus infection in mice was thought to be caused by minute mouse virus (MMV) and in rats by rat viral agents in the KRV or H-1 serogroups. Relatively newly discovered viruses in these groups are mouse (MPV) and rat parvoviruses (RPV-1 and 2). Parvoviruses are 15ā20 nm in diameter and are single-stranded DNA viruses of about 5,000 nucleotides, which replicate through a double-stranded DNA intermediate. The protein composition consists of three structural or capsid proteins providing the viral coat (VP-1, VP-2, and VP-3) and two non-structural proteins involved in viral replication (NS-1 and NS-2). Among the capsid proteins,VP-2 is the major protein…