Progress 10/01/07 to 09/30/08
Outputs
OUTPUTS: In 1999, Cornell University and the Ludwig Institute for Cancer Research, an international cancer research institute, forged a unique Partnership to establish a translational research facility. This translational facility links the basic discoveries in cancer vaccine to the front lines of battle on cancer, the bedsides of clinics. The activities at the Partnership include research in process development at the Bioprocess Research Laboratory and manufacturing of recombinant therapeutic cancer vaccines for use in clinical trials worldwide. The GMP compliant manufacturing facility is located on the Ithaca campus of Cornell University and operated by the Cornell University/Ludwig Institute for Cancer Research Partnership. The Biological Production Facility is an ISO Class7/8 group of manufacturing suites outfitted with latest equipments for the production of recombinant proteins from microbial hosts. From a 30 L bioreactor through to 7 L chromatography columns, the Biologics Production Facility is equipped for pilot-scale production. The manufacturing activity is supported by Quality Assurance and Quality Control groups. In 2007, our continued and tireless effort to produce a recombinant cancer-testis (CT) antigen was rewarded with a successful manufacturing campaign for a promising therapeutic cancer vaccine. The bulk purified recombinant cancer vaccine was analyzed by an outside certified laboratory and has been released for final formulation and vialing. In 2008, the bulk substance was formulated and vialed by an outside contract manufacturing organization. The vials were analyzed by a certified outside laboratory. The Ludwig Institute for Cancer Research submitted an amendment to the original antigen IND (Investigational New Drug) application on file with the FDA. Results of the filed amendment are pending, vials are expected to be in clinical trials in 2009. Using this production process as a blueprint, we have successfully developed a manufacturing process for a second cancer vaccine and working on process development for other cancer vaccine candidates. PARTICIPANTS: Nothing significant to report during this reporting period. TARGET AUDIENCES: Nothing significant to report during this reporting period. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.
Impacts
We are a footstep away from a milestone laid at the inception of the Partnership. The release of this recombinant cancer vaccine produced at the CU/LICR Partnership BPF is a major accomplishment. This cancer vaccine is the first in a series of therapeutic cancer vaccine candidates produced at the CU/LICR Partnership BPF for use in phase I/II clinical trials world wide.
Publications
- C.-J. Huang, R. Chen, T. Vannelli, F. Lee, E. Ritter, G. Ritter, L. Old, C. Batt. Expression and purification of the cancer antigen SSX2: a potential cancer vaccine, Prot. Expr. Purif. 56 (2007) 212-219. L. Damasceno, K. Anderson, G. Ritter, J. Cregg, L. Old, and C. Batt. Cooverexpression of chaperones for enhanced secretion of a single-chain antibody fragment in Pichia pastoris. Applied Microbiology and Biotechnology 74, no. 2 (2007): 381-389.
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Progress 10/01/06 to 09/30/07
Outputs
In 1999, Cornell University and the Ludwig Institute for Cancer Research, an international cancer research institute, forged a unique Partnership to establish a translational research facility. This translational facility links the basic discoveries in cancer vaccine to the front lines of battle on cancer, the bedsides of clinics. The activities at the Partnership include research in process development at the Bioprocess Research Laboratory and manufacturing of recombinant therapeutic cancer vaccines for use in clinical trials world wide. The cGMP compliant manufacturing facility is located on the Ithaca campus of Cornell University and operated by the Cornell University/Ludwig Institute for Cancer Research Partnership. The Biological Production Facility is an ISO Class7/8 group of manufacturing suites outfitted with latest equipments for the production of recombinant proteins from microbial hosts. From a 30 L bioreactor through to 7 L chromatography columns, the
Biologicals Production Facility is equipped for pilot-scale production. The manufacturing activity is supported by Quality Assurance and Quality Control groups. In 2007, our continued and tireless effort to produce a recombinant cancer-testis (CT) antigen was rewarded with a successful manufacturing campaign for a promising therapeutic cancer vaccine. The bulk purified recombinant cancer vaccine has been analyzed by an outside certified laboratory and has been released for final formulation and vialing. The vialed recombinant vaccine will be released to clinical trial centers after successful final testing and approval from the appropriate regulatory agency. Using this production process as a blueprint, we have successfully developed a manufacturing process for a second cancer vaccine and working on process development for other cancer vaccine candidates.
Impacts
We are a footstep away from a milestone laid at the inception of the Partnership. The release of this recombinant cancer vaccine produced at the CU/LICR Partnership BPF is a major accomplishment. This cancer vaccine is the first in a series of therapeutic cancer vaccine candidates produced at the CU/LICR Partnership BPF for use in phase I clinical trials world wide.
Publications
- No publications reported this period
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Progress 01/01/06 to 12/31/06
Outputs
In 1999, Cornell University and the Ludwig Institute for Cancer Research, an international cancer research institute, forged a unique Partnership to initiate and nurture a number of research and educational activities. The research activities include the establishment of the Bioprocess Research Laboratory and a manufacturing facility for production of clinical grade therapeutic recombinant proteins. These recombinant proteins are to be used in early human clinical trials for treatment of various cancers of the soft tissues. This unique partnership bridges the discoveries from Ludwig Institute for Cancer Research and ongoing clinical trials in leading hospitals around the world. The cGMP compliant manufacturing facility is located on the Ithaca campus of Cornell University and operated by the Cornell University/Ludwig Institute for Cancer Research Partnership. The focal point of this facility is to produce anticancer recombinant proteins for Phase I clinical trials, a
vital first step towards FDA licensing and product marketing. The Biological Production Facility is an ISO Class7/8 series of manufacturing suites outfitted with latest equipments for the production of recombinant proteins from microbial hosts. From a 30 L bioreactor through to 7 L chromatography columns, the Biologicals Production Facility is equipped for pilot-scale production. The manufacturing process is supported by Quality Assurance and Quality Control. In 2006, our efforts to develop a robust manufacturing process for a recombinant cancer-testis (CT) antigen were rewarded with a successful full scale development run. This run was repeated to demonstrate process reproducibility and robustness. The two successful development runs were followed by a successful full-scale production run with excellent results. Currently, analytical methods necessary for quality control assays are under development. The developed quality control assays will be used in analysis of bulk purified
recombinant protein prior to release for final processing and clinical use.
Impacts
With the successful production of a clinical-grade recombinant CT-antigen and its anticipated use in world-wide clinical trials, we have achieved a milestone laid at the inception of the Partnership. This recombinant CT-antigen promises to be the first in a long line of anti-cancer therapeutic candidates destined for phase I clinical trials produced at the CU/LICR Partnership BPF.
Publications
- No publications reported this period
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Progress 01/01/05 to 12/31/05
Outputs
In 1999, Cornell University and the Ludwig Institute for Cancer Research, an international cancer research institute, forged a unique Partnership to initiate and nurture a number of research and educational activities. The research activities include the establishment of the Bioprocess Research Laboratory and a manufacturing facility for production of recombinant proteins. These recombinant proteins are to be used in early human clinical trials for treatment of various cancers of the soft tissues. This unique partnership bridges the discoveries from Ludwig Institute for Cancer Research and ongoing clinical trials in leading hospitals around the world. The manufacturing facility is operated as a cGMP compliant facility located on the Cornell-Ithaca campus under the auspices of the Cornell University/Ludwig Institute for Cancer Research Partnership. The focal point of this facility is to produce anticancer recombinant proteins for Phase I clinical trials, a vital first
step towards FDA licensing and product marketing. The Biological Production Facility is an ISO Class7/8 series of manufacturing suites outfitted with latest equipments for the production of recombinant proteins from microbial hosts. From a 30 L bioreactor through to 4 L chromatography columns, the Biologicals Production Facility is equipped for pilot-scale production. The manufacturing process is supported by Quality Assurance and Quality Control. In 2005, our efforts were concentrated on the process development and production of a recombinant cancer-testis (CT) antigen. This CT-antigen is linked to various solid tumors and preliminary studies have demonstrated promise as a therapeutic agent. Although the process for high yield production of CT-antigen was difficult and challenging, our first full scale development run was successful and revealed areas of further development in buffer formulations. We have successfully addressed these areas and are presently preparing for a second
full scale development run. A successful completion of this development run will be followed immediately by a full manufacturing run and rigorous testing.
Impacts
With the production of a CT-antigen, we have gained experiences in production of an antibody fragment and a CT-antigen. We have used two different expression and downstream purification strategies to achieve these goals. This milestone is a further realization of the Partnership's mission to develop recombinant anti-cancer immunotherapeutic proteins at an academic institution. The two recombinant proteins manufactured in the facility are the first two in a long list of anti-cancer therapeutic candidates destined for phase I clinical trials. The knowledge gained from the production of these two recombinant proteins will facilitate a facile production of other antigens. The Partnership defines not just the working relationship between Cornell University and the Ludwig Institute of Cancer Research but illustrates the value in establishing unique alliances between institutions.
Publications
- No publications reported this period
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Progress 01/01/04 to 12/31/04
Outputs
In 1999, Cornell University and the Ludwig Institute for Cancer Research, an international cancer research institute, forged a unique Partnership to initiate and nurture a number of research and educational activities. The research activities include the establishment of the Bioprocess Research Laboratory and the current good manufacturing practices (cGMP) compliant Biologicals Production Facility. This unique partnership links discoveries at the many branches of the Ludwig Institute for Cancer Research and research and development at Cornell University to ongoing clinical trials for anticancer therapeutics. A cGMP compliant Biologicals Production Facility was established on the Cornell-Ithaca campus under the auspices of the Cornell University/Ludwig Institute for Cancer Research Partnership. The focal point of this facility is to produce anticancer recombinant proteins for Phase I clinical trials, a vital first step towards FDA licensing and product marketing. The
Biological Production Facility is an ISO Class7/8 series of manufacturing suites outfitted with latest equipments for the production of recombinant proteins from microbial hosts. From a 30 L bioreactor through to 4 L chromatography columns, the Biologicals Production Facility is equipped for pilot-scale production. The manufacturing process is supported by Quality Assurance and Quality Control. In 2004, two production runs dedicated to a synthetic antibody fragment molecule to colon cancer were completed. These two campaigns served as process optimization runs to address scale-up and process control issues. A third fermentation-only production run for a cancer antigen was completed. The purpose of this run was to optimize scale-up and fermentation process control processes.
Impacts
With the completion of first production campaigns in the Biologicals Production Facility, the Partnership has entered a new frontier; the production of recombinant proteins for use in early clinical trials. This step begins the realization of the Partnerships mission to develop recombinant anti-cancer immunotherapeutic proteins at an academic institution. The two recombinant proteins manufactured in the facility are the first two in a long list of anti-cancer therapeutic candidates destined for phase I clinical trials. The Partnership defines not just the working relationship between Cornell University and the Ludwig Institute of Cancer Research but illustrates the value in establishing unique alliances between institutions.
Publications
- Damasceno, L. M., I. Pla, H-J. Chang, L. Cohen, G. Ritter, L. J. Old, and C. A. Batt. 2004. An optimized fermentation process for high-level production of a single-chain Fv antibody fragment in Pichia pastoris. Protein Expression and Purification. 37:18-26.
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Progress 01/01/03 to 12/31/03
Outputs
The Ludwig Institute for Cancer Research is a global cancer research enterprise staffed by more than 750 scientists, clinicians, and support personnel. It bears the name of its founder, the American industrialist Daniel Ludwig. The Ludwig Institute operates ten research branches located in seven different countries around the world and are augmented by a vital network of collaborations with laboratory and clinical investigators at numerous academic institutions. The administrative headquarters of the Institute are in New York City where it also maintains a research branch at Memorial Sloan Kettering Cancer Center. In 1999, Cornell University and the Ludwig Institute for Cancer Research forged a unique partnership to initiate and nurture a number of research and educational activities with the establishment of the Bioprocess Research Laboratory on the Ithaca campus of Cornell University. In late 2002, a good manufacturing practices (GMP) compliant Biologics Production
Facility (BPF) was established adjacent to the existing Bioprocess Research Laboratory. Working in combination, the research and production activities at Cornell University play a vital role in linking the discoveries at the many branches of the Ludwig Institute for Cancer Research with ongoing clinical trials for cancer diagnosis and treatment. A GMP-compliant recombinant protein production facility affords the Ludwig Institute for Cancer Research and potentially other academic, government and privat-sector partners, the ability to make GMP-grade material will provide an opportunity to gain a proof-of-concept validation in small clinical and other experimental trials. The cGMP-compliant Biologics Production Facility is a series of ISO Class 8 and 7 suites outfitted with latest equipments for the production of recombinant proteins from microbial hosts. The facility is capable of pilot-scale production under cGMP compliant conditions. The facility support systems were successfully
commissioned and the qualificatin of facility equipments are nearing completion. In late 2003, the inaugural production campaign to manufacture a recombinant protein targeting colon cancer was initiated. This campaign is currently in progress.
Impacts
The Biologics Production Facility and the Bioprocess Research Laboratory together are an integral part of a training program for the undergraduate and graduate students, enriching the academic environment of Cornell in the area of bioengineering. The Partnership's mission to develop immunotherapeutic anti-cancer agents within the context of an academic environment provides training opportunities for students and research associates with an interest in translational research. The Partnership defines not just the working relationship between Cornell University and the Ludwig Institute for Cancer Research but illustrates the value in establishing unique alliances between institutions.
Publications
- No publications reported this period
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Progress 01/01/02 to 12/31/02
Outputs
In 1999, Cornell University and the Ludwig Institute for Cancer Research forged a unique Partnership to initiate and nurture a number of research and educational activities. The research activities include the establishment of the Bioprocess Research Laboratory and the planned Good Manufacturing Practices GMP BioProduction Facility. Working in combination they will link discoveries at the many branches of the Ludwig Institute for Cancer Research and research and development at Cornell University to ongoing clinical trials. The Ludwig Institute for Cancer Research is a global cancer research enterprise staffed by more than 750 scientists, clinicians, and support personnel. It bears the name of its founder, the American industrialist Daniel Ludwig. Research operations are on-going at ten Ludwig Institute Branches located in seven different countries around the world and are augmented by a vital network of collaborations with laboratory and clinical investigators at a
host of academic institutions. The Institute's administrative headquarters of the Institute are in New York City and the Institute maintains a research Branch at Memorial Sloan Kettering in New York City as well. In the A Good Manufacturing Practices (GMP) BioProduction Facility to produce therapeutic anticancer agents for Phase I clinical trials has been established on the Cornell-Ithaca campus under the auspices of the Cornell University/Ludwig Institute for Cancer Research Partnership. Both for the Ludwig Institute for Cancer Research and potentially other academic, government and private-sector partners, the ability to make GMP-grade material will provide an opportunity to gain proof-of-concept validation in small clinical and other experimental trials. Success from these demonstration trials will provide an impetus for further development and eventual entry of these therapeutic into the marketplace. The GMP BioProduction Facility and the Bioprocess Research Laboratory together
are an integral part of a training program for undergraduate and graduate students, enriching the academic environment of Cornell in the area of bioengineering. The GMP BioProduction is a class 10,000 series of clean rooms outfitted with a complete suite of equipment for the production of recombinant proteins from microbial and eukaryotic hosts. From a 30 L bioreactor through all of the equipment needs for downstream processing including cell disruption, concentration and purification, the GMP BioProduction Facility is capable of large-scale production under cGMP compliant conditions.
Impacts
The Partnership's mission to develop therapeutic anti-cancer agents within the context of an academic environment provides training opportunities for students and research associates with an interest in translational research. The Partnership defines not just the working relationship between Cornell University and the Ludwig Institute of Cancer Research but illustrates the value in establishing unique alliances between institutions.
Publications
- No publications reported this period
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Progress 01/01/01 to 12/31/01
Outputs
In 1999, Cornell University and the Ludwig Institute for Cancer Research forged a unique Partnership to initiate and nurture a number of research and educational activities. The research activities include the establishment of the Bioprocess Research Laboratory and the planned Good Manufacturing Practices GMP BioProduction Facility. Working in combination they will link discoveries at the many branches of the Ludwig Institute for Cancer Research and research and development at Cornell University to ongoing clinical trials. The Ludwig Institute for Cancer Research is a global cancer research enterprise staffed by more than 750 scientists, clinicians, and support personnel. It bears the name of its founder, the American industrialist Daniel Ludwig. Research operations are on-going at ten Ludwig Institute Branches located in seven different countries around the world and are augmented by a vital network of collaborations with laboratory and clinical investigators at a
host of academic institutions. The Institute's administrative headquarters of the Institute are in New York City and the Institute maintains a research Branch at Memorial Sloan Kettering in New York City as well. In the Spring, 2001, construction of an interim Good Manufacturing Practices Bioproduction Facility was begun. This facility will provide small quantities of therapeutic agents for Phase I clinical trials. The 1500 square foot facility will be built in Stocking Hall and as an added benefit, a new food microbiology teaching laboratory will be established. The interim GMP facility will not only provide a link in the process from the discovery of therapeutic agents to clinical trials but will also provide a platform for training students in biotechnology.
Impacts
The Partnership's mission to develop therapeutic anti-cancer agents within the context of an academic environment provides training opportunities for students and research associates with an interest in translational research. The Partnership defines not just the working relationship between Cornell University and the Ludwig Institute of Cancer Research but illustrates the value in establishing unique alliances between institutions.
Publications
- No publications reported this period
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Progress 01/01/00 to 12/31/00
Outputs
A laboratory has been established to express tumor antigens in a recombinant system
Impacts
Novel treatments for cancer will be developed and tested in clinical trials.
Publications
- No publications reported this period
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Progress 01/01/99 to 12/31/99
Outputs
Expression systems for the recombinant production of the tumor antigen A33 are being developed. Hosts including Escherichia coli, Saccharomyces cerevisiae, Pichia pastoris and baculovirus are being developed in a parallel fashion.
Impacts
Tumor antigens have potential value as immunotherapeutics.
Publications
- No publications reported this period
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