Tag: <span>adenoviral vectors</span>

Adenoviral vectors for gene delivery are being tested in the clinic for a number of indications and therapeutic uses. In order to facilitate the comparison of studies from different laboratories, the Adenovirus Reference Material Working Group (ARMWG) has developed a reference testing reagent, which will be referred to as the Wild Type Ad5 Adenoviral Reference Material (ARM). This ARM will allow laboratories to standardize in-house controls employed in assays for the determination of particle concentration and infectious titer of their own adenoviral preparations. As part of this project, short-term field use and shipping studies were performed on the ARM. The virus was found to be stable under simulated shipping conditions, for one thaw after shipping, and at 4 °C for up to four hours after thawing. However, there was evidence of aggregation in some vials with repeated freeze-thaw cycles. Therefore, we recommend that each vial be treated as a single-use aliquot, and that it be used within four hours of thawing…

Viral Reference Materials

The development of reference testing reagents has been used successfully in the past to standardize measurements among laboratories, particularly for biological products such as recombinant cytokines. This approach was recommended by many parties with a stake in adenovirus vector delivery in order to address the fact that particle units and infectious units are not standardized in the field. This has made interpretation of preclinical and clinical data, as it relates to the amount of adenovirus vector administered, difficult to compare across the field. An Adenovirus Reference Material is being developed to define the particle unit and infectious unit for adenovirus gene vectors, and create a commonality for comparisons, especially for data related to vector safety…

Viral Reference Materials Viral Vectors

Introgen Therapeutics has been producing clinical-grade adenoviral vectors in scaled-up processes, in cGMP facilities, for over five years. Semi-automated hand filling, using a Watson-Marlow 505Di/L pump, has been used over this period to fill batch sizes of up to 2 liters of adenovirus. While this procedure has been robust and demonstrated a high level of sterility assurance through regularly scheduled media fill studies and product testing, the firm needed to move to the next level of fill sizes. Anticipating up to 10,000 fills in 3 mL vials, Introgen has worked in collaboration with M&O Perry Corp. to develop an automated fill capability that utilizes the same base procedure but in an automated fashion…

Biologics Production Viral Vectors

A formulation for purified adenoviral vectors was developed that provides stability through freeze-thaw stress and long-term storage at non-frozen temperatures. To evaluate the various test conditions, a panel of stability indicating methods was assembled, which included laser light scattering, HPLC, and transgene expression assays. Preformulation studies were conducted, and the effects of buffer species, pH, cryoprotectants, and salts upon adenoviral vector stability were determined…

Viral Vectors

In orthopedic procedures, there is a need to form new bone to repair and fill defects arising from either trauma or degenerative disease. The current standard treatment utilizes an autograft, usually from the iliac crest, which results in a second surgical site, weakness in the harvest or donor harvest area, and additional patient morbidity. The goal of our research is to employ a local, ex vivo, gene therapy to obviate the need for autograft in spine fusion procedures. The LIM Mineralization Protein (LMP-1) is a novel intracellular protein capable of inducing bone formation in vitro and in vivo. In this article, I will outline a rapid protocol, whereby buffy coat cells, isolated from autologous peripheral blood, are transduced with an adenoviral vector encoding the LMP-1 gene. These transduced cells are then implanted on a collagen carrier to promote posterolateral arthodesis…

Cell & Gene Therapy