Full-Service cGMP Pharmaceutical Manufacturing

Vista Biological Corporation is a full-service cGMP Contract Pharmaceutical Manufacturing Organization operating under cGMP standards. Strategically located in Southern California, Vista Biologicals is revolutionizing the biotechnology and pharmaceutical industries through its comprehensive cGMP contract manufacturing services. Serving clients in San Diego County, Orange County, and beyond, we are dedicated to delivering exceptional results.

We prioritize the quality and integrity of our products. That's why we exclusively source Fetal Bovine Serum (FBS) from verified and reputable suppliers in the United States, New Zealand, and Australia. Our specialized expertise lies in the development and manufacturing of a wide range of products for research, commercial production, and clinical supply purposes. Whether you require formulation development, scale-up production, or clinical trial material manufacturing, our skilled team is equipped to meet your specific needs.

Pharmaceutical Lab Services: Pilot Scale Production

Vista Biologicals offers pilot-scale production services in a cGMP manufacturing environment for preclinical and Phase I-II clinical drug evaluation programs. Our pharmaceutical lab services are equipped to handle projects ranging from milligram-scale to kilogram-scale and everything in-between. With our top notch personnel and state-of-the-art facilities, we deliver efficient turnaround times and exceptional outcomes. 

Cell Culture

Products derived from animal cell culture are VBC’s specialty. Vista Biologicals has extensive expertise in the requirements for the most commonly used culture types—in batch, fed-batch and perfusion modes—including the following:

Vista Biologicals can harvest, capture, purify and polish your product according to your specifications. Whether your deliverables include a simple shipment of a conditioned medium, a formulated bulk drug for clinical trials, or anything in between, Vista Biologicals has the extensive experience and equipment to bring high-quality, consistent performance to the purification of your product. In addition, VBC can work with the client to design, develop, and optimize each step of the process.

Insect Cell Culture

The use of insect cell culture for protein expression has increased dramatically over the last several decades—becoming a routine expression system for basic research and large-scale commercial operations. Currently they are used commercially in the production of sub-unit vaccines, the manufacture of in vitro diagnostic materials, as well as in the manufacturing of in vivo therapeutics. The ability of insect cells to produce relatively large quantities of post-translationally modified eukaryotic proteins in a relatively short period of time has driven the acceptance of this technology.

The Baculovirus Expression Vector System

The BEVS, developed by Max Summers and Lois Miller, has unique biological advantages over bacterial, yeast or mammalian protein expression systems. A major advantage is the quick turnaround time for the expression of recombinant proteins that show biological activity, antigenicity, and immunogenicity similar to authentic natural proteins.

The Virus

The most commonly used expression system is based on the Autographa californica Nuclear Polyhedrosis Virus (AcNPV), an insect baculovirus isolated from the Alfalfa Looper. The baculovirus expression vector system has been used to express genes derived from viruses, fungi, bacteria, plants, and animals. In this system, the genes of interest are placed under the control of the polyhedrin promoter of the AcNPV.

The Cell Lines

The most widely used insect cells for BEVS are the Sf9 and Sf21 cell lines isolated from the ovarian tissue of the fall army worm, Spodoptera frugiperda, and the High Five cell line, designated BTI-Tn-5B1-4, originally established from Trichoplusia ni embryonic tissue. Sf9 or Sf21 cells are preferred for virus expansion, while any of the cell lines make excellent expression systems for production.

Bevs at Vista

Vista Biologicals’ molecular biologists work closely with the client to clone and express full-length recombinant proteins from full-length cDNAs, EST sequence information or genomic sequences. The genes are cloned in baculovirus vectors and expressed in insect cells. They can produce milligram amounts of recombinant protein suitable for functional screening and biological testing using a purification process that is either provided by the customer or developed in-house. Production is performed at a scale (up to 1,000L) appropriate to the needs of the client. Should the client decide to enter into clinical development, Vista Biologicals can provide recombinant proteins for use in Phase I and II human clinical trials. In addition, VBC can prepare the necessary regulatory documents for submissions to the appropriate institutional authorities.

Mammalian Cell Culture

With the emergence of recombinant DNA technology in the 1970s, mammalian cell culture has become a crucial method for producing proteins with essential post-translational modification, such as glycosylation. Unlike bacteria, mammalian cells excel in performing these complex modifications. In the present era, numerous biopharmaceuticals have been successfully manufactured using mammalian cell culture, and the potential for more breakthroughs in this field is vast. At Vista Biologicals, we specialize in working with mammalian cell cultures, harnessing their capabilities for the production of innovative biopharmaceuticals. 

Industry-Leading Experience

Vista Biologicals has been involved in the development and optimization of mammalian cell culture processes since their inception in 1981. We offer their clients a wide range of services, including:

HYBRIDOMA | MAB

Monoclonal antibodies (mAb) are important reagents in biomedical research. They are used in the identification of proteins, carbohydrates, and nucleic acids. Their use has led to the elucidation of many molecules that control cell replication and differentiation, advancing their knowledge of the relationship between molecular structure and function. These advances in basic biologic sciences have improved their understanding of the host response to infectious-disease agents and toxins produced by these agents, to transplanted organs and tissues, and to tumors. In addition, the specificity of monoclonal antibodies allows them to be used for the diagnosis and treatment of disease.

Hybridomas

Monoclonal antibodies are produced by cell lines or clones obtained from animals, generally mice, that have been immunized with a substance of interest. The hybridoma cell lines are produced by fusing B cells from the spleen of the immunized animal with myeloma cells (Köhler and Milstein 1975). To produce the desired mAb, the cells must be grown in culture and the antibody is then prepared from the conditioned tissue-culture medium.

Vista Biologicals has worked at all levels of the process subsequent to the immunization of the mouse and the initial fusion of the spleen cells. We have performed refusion of cell lines, clonal selection of the cells, medium optimization, adaptation of the cells to serum free media, cell banking and characterization, optimization of antibody production, scale-up, purification development and optimization, characterization of the product, preparation of reference lots, and formulation and stability studies of the purified product. VBC has prepared material for preclinical and clinical studies in quantities ranging from a few milligrams to over one kilogram.

Microcarrier Culture

Many cell lines are said to be “anchorage dependent,” which means that in order to grow and divide they must attach themselves to a suitable surface. Large-scale production of anchorage-dependent cells or cell derived products has had to rely on methods other than a simple linear expansion of this process. Traditionally, roller bottles have been employed for this task. The rolling action ensures that the cells are alternatively exposed to growth medium and oxygen. However, the roller bottle method is very cumbersome and expensive for the production of large quantities of cells for a number of reasons: the roller bottles are an inefficient use of space, the handling requires extensive labor and medium, and the process is difficult to monitor. Vista Biologicals uses microcarrier suspension culture instead, as it provides reliable success rates without the inefficiencies or costs of roller bottles.

Microcarriers 

Vista Biologicals has worked with microcarriers since their inception. We have grown a large number of different cell types on microcarriers in perfusion mode. VBC has worked extensively with microcarrier perfusion cultures which can maintain cells at very high densities for extended periods of time (one ten-liter culture was maintained in continuous operation for a year).