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The Road Ahead for Biologics Manufacturing

by Peter L. Ginsberg, Sandeep Bhatia, PhD, and Rachel L. McMinn, PhD
Volume 1, Issue 1 (March 2002)

Protein-based therapeutics have led to the emergence of the biotechnology industry and should drive rapid growth in the industry over the next decade. In 2001 alone, six major biologics were approved by the FDA. According to our analysis, there are 39 biologic products (antibodies and non-antibody recombinant proteins) that are currently in Phase III clinical testing and about 60 in Phase II testing, which we estimate could lead to 34 new products on the market in the next four to six years. By our estimates, such a new product outpouring would lead to more than a doubling of the number of profitable biopharmaceutical product companies (currently 15) by mid-decade. The focus of this report is to evaluate the manufacturing aspects of biotechnology models and analyze the current and future capacity needs of the industry...

Citation:
Ginsberg PL, Bhatia S, McMinn RL. The Road Ahead for Biologics Manufacturing. BioProcess J, 2002; 1(1): 19-21.

 
Industry Observations and Perspectives Part I

by Keith L. Carson
Volume 1, Issue 1 (March 2002)

Baculovirus expression technology, or BEVS, gained its first broad industry exposure in the early 1980s, primarily through the many papers published by students and post-doctoral fellows in Dr. Max Summers' laboratory at Texas A&M University (College Station, Texas). This technology fostered popular appeal because of its simplicity and high protein expression capabilities. As more work was done, it became even more evident that this was a very rapid, and relatively inexpensive method for producing proteins. It was also postulated that BEVS would offer a valuable means of producing recombinant proteins for use in human therapy, especially since baculovirus was considered non-infectious to human cells. It was thought that any problems with post-translational modifications of the manufactured proteins could be worked out, and fully functional glycoproteins could be manufactured...

Citation:
Carson KL. Industry Observations and Perspectives Part I. BioProcess J, 2002; 1(1): 22-24.

 
Development of a Reference Material for Characterizing Adenovirus Vectors

by Beth Hutchins, PhD
Volume 1, Issue 1 (March 2002)

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...

Citation:
Hutchins B. Development of a Reference Material for Characterizing Adenovirus Vectors. BioProcess J, 2002; 1(1): 25-29.

 
Ex Vivo Activation and Adoptive Transfer of T Cells for Immune Augmentation

by Bruce L. Levine, PhD
Volume 1, Issue 1 (March 2002)

We have developed a procedure for large-scale enrichment, growth and harvesting of T cells suitable for adoptive immunotherapy. In two recently completed clinical trials, we investigated the feasibility of immune reconstitution in patients with HIV infection, or with relapsed/refractory Non-Hodgkin's Lymphoma (NHL) following infusions of autologous activated CD4+ T cells or CD4+/CD8+ T cells. Autologous T cells were activated via CD3/CD28 stimulation, ex vivo, and were then reinfused...

Citation:
Levine BL. Ex Vivo Activation and Adoptive Transfer of T Cells for Immune Augmentation. BioProcess J, 2002; 1(1): 31-37.

 
Development of Capabilities for Small-Scale Virus Fills

by Joseph H. Senesac, Frank Flagge, and Shawn Gallagher
Volume 1, Issue 1 (March 2002)

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...

Citation:
Senesac JH, Flagge F, Gallagher S. Development of Capabilities for Small-Scale Virus Fills. BioProcess J, 2002; 1(1): 38-42.

 
Development of a Stable Adenoviral Vector Formulation

by Diana K. Hoganson, Julie C. Ma, Lara Asato, Mike Ong, Marie A. Printz, Bernard G. Huyghe, Barbara A. Sosnowski, PhD, and Mark J. D'Andrea
Volume 1, Issue 1 (March 2002)

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...

Citation:
Hoganson DK, Ma JC, Asato L, Ong M, Printz MA, Huyghe BG, Sosnowski BA, D'Andrea MJ. Development of a Stable Adenoviral Vector Formulation. BioProcess J, 2002; 1(1): 43-48.

 
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