Principal Scientist


Delano R. Freeberg

npchemist@yahoo.com
636.856.0485

208 Split Rail Drive
Wentzville, MO 63385 
USA  États-Unis


Career Highlights
Professional Chronology
Patents, Publications, and Presentations
Honours and Awards
Professional Affiliations
Education
Seminars and Workshops
Volunteer Activities
Selected Achievements
Other Capabilities


CURRENT RESPONSIBILITIES
___________________________________________________________________

Principal Scientist
API Purifications LLC
St. Louis, MO



CAREER SUMMARY
___________________________________________________________________

Leadership and technical expertise in purification process design, DSP from fermentation, and extraction and purification from biological sources for small molecule, protein, secondary metabolite, and trace compound from bench discovery and development through pilot. Team leadership and expertise in HPLC including six-day cGMP method development, validation and HTS method development. Special proficiency in analysis of complex formulations and biological matrices to include trace contaminants analysis. New product discovery and development and process development through pilot to production. Deep expertise in purification process design from animal, botanical, fermentation, marine, cell culture, and recombinant sources. Expertise in purification including extraction, process chromatography, non-chromatographic purification, crystallization and blending and formulation to include incompatible materials. Broad experience in formulations, chromatography, native- and SDS-PAGE, thermal analysis, spectrometry, and wet techniques. Simultaneous management of multiple projects. Consistent individual achievement while fostering a collaborative environment.



CAREER HIGHLIGHTS
___________________________________________________________________

Protein Purification
Team leader and inventor of a dual-column, single-step process for isolation of 99+% pure protein from plant source. 62% to 80% process recovery with column loading of 320 to 450 grams protein per liter. Twelve-fold efficiency increase over best previous process and six-fold reduction in processing cost. Product to go commercial in late 2011.

Fermentation DSP
Sole inventor of four-step isolation of 99+% pure fermentation-derived geldanamycin and all associated analytical methods. Extraordinary efficiency and 69% process recovery allowed sale below worldwide market price. Chemical and Engineering News, March 29, 2004, inside back cover.

Purification from Botanicals
Chief inventor of four steps of a 3rd generation paclitaxel process. Coordinated research and development to pilot and production. Recovery increased 80% over 2nd generation process. Process cost reduced by 42%. Savings of several million dollars over 2nd generation process.

Herbal Supplements
Leading a team of six scientists, developed six herbal supplements for the Wyeth Centrum multi-vitamin line. Kept all six teams on track through an 11-month period to commercialization, including bio-guided assay for extract optimization, process development, formulation and stability studies, and final process. Developed all in-process and release analytical methods.

Analytical Development
Principal scientific contributor to the project team evaluated by the FDA in a Pre-Approval Inspection in December, 2005. The FDA did not issue a Form 483 (notice of non-compliance). First instance of an inspection without 483s in the 26-year history of Paddock Laboratories.



PROFESSIONAL CHRONOLOGY
___________________________________________________________________

API Purifications LLC, St. Louis, MO, 2001 to Present    
Principal Scientist 2001 to Present

Founder, President, and Chief Technical Officer of API Purifications. Consultant to pharmaceutical companies in Canada, the United States, and Europe. Expertise in all matters pertaining to separations, including purification process design, DSP from fermentation, small molecule purification, protein purification, impurity and metabolite isolation, and analytical development and validation. Deep expertise in HPLC method development. Expertise in isolation of actives from biological matrices, including fermentation broth, botanical, marine, animal, cell culture, and recombinant sources.

Achievement Highlight: Technical Consulting
Consulted on-site for a Toronto company, developed chromatographic and process improvements that resulted in a two-fold decrease in labor commitment and 60% reduction in processing costs.

Achievement Highlight: Technical Products
Wrote the 198-page "APIPREP manual" and associated technical software for efficient scaling from analytical HPLC to preparative HPLC. Manual and software licences have been sold in the United States and Canada.

Achievement Highlight: Business Development
Established contractual consulting relationships with 29 client companies across North America. Built a base of 1450 professional contacts at 345 companies across the continent.



Novus International, Inc., St. Charles, MO
Senior Process Scientist 2007 to 2009

Chief new products development chemist. Led a team of four chemists in purification process development, analytical method development, candidate screening, and formulation development. Expertise in actives isolation from biomass, synergy optimization, stabilization, and efficacy determination.

Achievement Highlight: Breakthrough Innovation
Researched and shepherded through bench development a new line of high-efficacy, all-natural antioxidants competitive with or out-performing synthetic antioxidants. This new line constitutes the first such all-natural offering in animal nutrition and animal feed stabilization in the history of the industry.



Paddock Laboratories, Inc., Minneapolis, MN
Senior Analytical Scientist II 2005 to 2007

Senior scientific cGMP responsibility for analytical method development, validation, and transfer to QC. Chief separations and HPLC consultant to the company. Teaching responsibilities in development methodologies and chromatography.

Achievement Highlight: No 483s
Principal scientific contributor to the project team evaluated by the FDA in a Pre-Approval Inspection in December, 2005. The FDA did not issue a Form 483 (notice of non-compliance). This was the first instance of an inspection without 483s in the 26-year history of Paddock Laboratories.



Albany Molecular Research Inc, Mt. Prospect, IL
Senior Research Scientist I (Chemist V) 2002 to 2004
Senior Research Scientist    (Chemist IV) 2001 to 2002

Chief separations scientist for the Biosciences Division of Albany Molecular Research Inc. Primary separations resource for 40 senior-level synthetic chemists. Expertise in purification process design from microbial, botanical, and enzymatic matrices. Development of pharmaceutical purification processes, high-throughput techniques, analytical methods, and purification routines.

Primary responsibilities: Chief technical accountability in all areas of separations. Project management authority in gram- to Kg-scale isolations. Final technical signing authority for all matters pertaining to chromatography, and for all SOPs relating to new leads analytical qualification, analytical and preparative HPLC, and sample preparation. Consultative responsibilities for milligram-scale isolations, HPLC method development and writing, and sample preparation. Bid and proposal preparation, technical project management, and supervisory and consultative responsibilities.

Achievement Highlight: Complete Isolation of Geldanamycin
Sole inventor of cost-effective geldanamycin purification process. Delivered 99+% pure geldanamycin from fermentation broth in a four-step non-chromatographic 
process with 69% process recovery. Able to beat all worldwide competitors on 
price.  C&E News, March 29, 2004, inside back cover.



Hauser, Inc., Boulder, CO
Research Scientist                    (Chemist III) 1997 to 2001
Staff Research Chemist            (Chemist II)   1995 to 1997
Research Chemist                      (Chemist I)    1993 to 1995
Associate Research Chemist                            1992 to 1993

Development of pharmaceutical and nutraceutical purification processes. Research in the isolation of pure and semi-purified actives from botanical and animal sources. Development of bulk isolation processes and supervision of scale-up and initial production.  Expertise in purification process design. Separations and purification research, process development, and scale-up of pharmaceuticals and nutraceuticals. Technical project management, supervisory and consultative responsibilities.

Primary pharmaceutical responsibilities: Senior technical accountability in 
crystallization battery. Major accountability in process research, flash 
chromatography and long column, impurity isolation, analytical method development, and computer process modeling. Significant accountability in structural elucidation. Twelve major projects including paclitaxel, michellamine B, 
cephalomannine, novel taxanes, and saponins of Acacia victoriae. 

Primary nutraceutical responsibilities: Senior technical accountability in new 
process development, including all aspects of extraction and purification, 
analytical method development, and fractionation and isolation for bio-guided 
assay. Major technical accountability and consultative responsibility in contract 
research for outside clients. Fourteen major projects; dozens of minor projects.

Achievement Highlight: Pharmaceuticals

Primary inventor of Paclitaxel crystallization sequence
Chief inventor of four steps in this major pharmaceutical process. Coordinated 
research and development of all four steps to pilot and production. Recovery 
increased 80% over 2nd generation process. Rework reduced by 85%. Process cost reduced by 42%. Savings of several million dollars over 2nd generation process.

Achievement Highlight: Nutraceuticals

Project Leader for major nutraceuticals effort
Project leader for six of ten herbals for a major outside client. Led six teams in 
fractionation for bio-directed assay and isolation of actives over a seven-month 
period. The products were commercially available less than 12 months after 
development.



PATENTS
___________________________________________________________________

Freeberg, D. R.; et al.; U.S. Patent 7,682,637: “Efficient Method for Producing Compositions Enriched in Total Phenols.” Issued 23 March 2010.

Freeberg, D. R.; et al.; U.S. Patent 7,462,370: “Compositions enriched in anthocyanins.” Issued 9 December 2008.

Freeberg, D. R.; et al.; U.S. Patent 7,306,815: “Compositions enriched in phenolic compounds and methods for producing the same.” Issued 11 December 2007.

Freeberg, D. R.; et al.; U.S. Patent 6,960,360: “Efficient method for producing compositions enriched in total phenols.” Issued 1 November 2005.

Freeberg, D. R.; et al.; International Patent WO2005072762. “Compositions Enriched in Phenolic Compounds and Methods for Producing the Same.” Issued 11 August 2005.

Freeberg, D. R.; et al.; U.S. Patent 6,780,442: “Efficient method for producing compositions enriched in anthocyanins.” Issued 24 August 2004.

Freeberg, D. R.; et al.; European Patent EP1328282: “Efficient Method for Producing Compositions Enriched in Anthocyanins.” Issued 23 July 2003.


PATENTS PENDING
___________________________________________________________________

Freeberg, D. R.; et al.; Canadian Patent 2,506,651: “Procédé de Production Efficace de Compositions Enrichies en Phenols Totaux.” Patent Pending; in National Phase.

Freeberg, D. R.; et al.; Canadian Patent 2,421,109: Procédé de production à haut rendement de compositions enrichies en anthocyanes.” Patent Pending; in National Phase.

Several other patents pending.


PRESENTATIONS
___________________________________________________________________

Freeberg, D. R.; et al.; “Generation of Semi-Synthetic Opiates and Scale Up via Whole Cell Biocatalysis”; Society for Industrial Microbiology annual meeting, Minneapolis, MN, August 10-14, 2003.

Freeberg, D. R.; et al.; “Generation of an Alkaloid Metabolite via Wholecell Biocatalysis”; Society for Industrial Microbiology annual meeting, Minneapolis, MN, August 10-14, 2003.

Freeberg, D. R.; Z. Liu; et al.; “Isolation and Structural Elucidation of Selected Saponins of Acacia victoriae”; American Society of Pharmacognosy national meeting, Seattle, Washington, USA; July, 2000.

Freeberg, D. R.; “Physical and Chemical Characterization of Phase I and Phase II Sodium Tripolyphosphates”; Albright and Wilson Chemical Company; Toronto, Ontario, CANADA; April, 1991.


PUBLICATIONS ___________________________________________________________________

Jayatilake, G. S.; D. R. Freeberg; et al.; "Isolation and 
Structures of Avicins D and G: In Vitro Tumor-Inhibitory Saponins Derived from 
Acacia victoriae"; J. Nat. Prod. 2003, 66, 779-783.

Freeberg, D. R.; "Alkali Metal Ion Catalysis in the Reactions of Hydrogen 
Peroxide and Halide Salts"; Abstracts of the 29th International Science and 
Engineering Fair; Science Service; Washington, D.C.; 1978.

HONOURS AND AWARDS
___________________________________________________________________

Honorary Doctoral Degree in Chemistry
U.S. Air Force Systems Command
Dayton, OH, USA.

Outstanding Service Award
For outstanding service to Hauser Inc.
Hauser Inc., Boulder, CO.

International Science Fair First-Place Awards
     First Place, Chemistry, United States Air Force
     First Place, Chemistry, National Aeronautics and Space Administration
Awarded at the International Science and Engineering Fair
Anaheim, CA, USA.

American Chemical Society Scholar

Rosenfield Scholar


PROFESSIONAL AFFILIATIONS
___________________________________________________________________

American Chemical Society
American Society of Pharmacognosy
American Oil Chemists Society
Canadian Society for Pharmaceutical Sciences
Canadian Society for Chemistry
Canadian Historical Association
National Peace Corps Association


EDUCATION
___________________________________________________________________

B.A. in chemistry and Russian, Grinnell College, Grinnell, IA, USA.
Certificate in French, Level 4, Foreign Service Inst., U.S. State Dept., Wash., D.C.
Hazmat Incident Command Certification, OSHA CFR 1910.120, Denver, CO, USA.


LANGUAGES
___________________________________________________________________

English: Native language.
French: Full professional fluency. Taught in French for two years.
Spanish: Written fluency, conversational competency. Six years in high school.
Russian: Conversational competency. Bachelor's degree in Russian.
German: Limited competency. One year of university German.


SEMINARS ___________________________________________________________________

American Oil Chemists Society Annual Meeting, May 2008, Seattle, WA, USA.
Analytica 2006, April 2006, Munich, GERMANY.
Pittcon 2004, March 2004, Chicago, IL, USA.
Prep 2003, July 2003, San Francisco, CA, USA.
HPLC 2002, July 2002, Montréal, QC, CANADA.
Combinatorial Chemistry and HTS Workshop, July 2001, Albany, NY, USA.
HPLC Method Validation, October 1999, Bellevue, WA, USA.
CU-Hauser Natural Products Symposium, May 1999, Univ. of Colorado, 
          Boulder, CO, USA.
An Overview of Natural Products Chemistry, April 1994, Hauser Chemical 
          Research, Boulder, CO, USA.
X-Ray Diffractometre Operation (for certification), March 1990, 
          University of Minnesota, Minneapolis, MN, USA.
Interfacial Chemistry, February 1991, Ecolab, Inc., St. Paul, MN, USA.
Rheometrics Fluid Spectrometre Operation, April 1990, Univ. of 
          Minnesota, Minneapolis, MN, USA.
Adhesion Theory, February 1989, Ecolab, Inc., St. Paul, MN, USA.


Workshops
___________________________________________________________________

Aseptic transfer, Low Endotoxin Conditions, July, 2010, St. Louis, MO, USA.
Melamine Regulatory Workshop, May, 2010, St. Louis, MO, USA.
Depth Filtration, 3M Filtration Products, October, 2009, St. Louis, MO, USA.
Antioxidant Behavior, May 2008, Seattle, WA, USA.
Advanced HPLC, May 2006, Minneapolis, MN, USA.
LC/MS Workshop II, February 2004, Chicago, IL, USA.
Separations Science Workshop, February 2004, Chicago, IL, USA.
LC/MS Workshop I, September 2003, Chicago, IL, USA.
HPLC Method Development Workshop, July, 2002, Chicago, IL, USA.
Aseptic Transfer, June, 2001, Iowa City, IA, USA.
Selectivity Considerations in HPLC, April 2001, Denver, CO, USA.
Mac-Mod HPLC Open Forum 10, November 2000, Boulder, CO, USA.
HPLC Method Development, March 1999, Denver, CO, USA.
NovaPrep 800 Operation, LC Support, March 1998, Boulder, CO, USA.
Hitachi HPLC 7000 Series Operation, January 1998, Boulder, CO, USA.
Mac-Mod HPLC Open Forum 4, October 1997, Boulder, CO, USA.
Advances in HPLC Seminar, July, 1996, Denver, CO, USA.
Preparative HPLC Operation, R&S Technology Inc., March 1995, Boulder, CO, USA.
Rheometrics Fluid Spectrometer Operation, April 1990, U of MN, Mpls, MN, USA.
X-Ray Diffractometer Certification Course, March 1990, U of MN, Mpls, MN, USA.


VOLUNTEER ACTIVITIES
___________________________________________________________________

Peace Corps Volunteer
U.S. Peace Corps, Sokode, Togo, West Africa, 2 Years of Service
Professeur des Sciences Physiques

Taught Chemistry and Physics at all Lycée Levels
Taught chemistry and physics to over 700 students in 9 programmes at 3 levels.
All lectures, tests, and class activities were conducted in French.

On-going Volunteer Activities
Regular blood donation (3-4 times per year).
Active in several capacities at my place of worship on a weekly basis.
Adult Leader in Boy Scouts of America. Active in various Returned Peace Corps Volunteer organizations.
Frequent Science Fair judge.

SELECTED ACHIEVEMENTS
___________________________________________________________________

Complete isolation of Geldanamycin
Sole inventor of cost-effective geldanamycin purification process. Delivered 99+% pure geldanamycin from fermentation broth in a four-step non-chromatographic 
process with 69% process recovery. Able to beat all worldwide competitors on 
price.

Glycosylated protein purification
Designed radical mobile phase that allowed simultaneous elution inversion and 
resolution enhancement with a 75% reduction in processing time. This and other 
changes allowed the isolation of certain glycosylated proteins at any scale with 
excellent purity and recovery, with no native protein in final product.  Sole inventor.

Doxorubicin purification
Developed first purification process capable of quantitative recovery of 
doxorubicin.  Sole inventor.

Cyclosporin analog purification
Created innovative, low-cost process for efficient isolation of a cyclosporin 
analog from complex matrices. Multi-dimensional LC was used to achieve this goal.  Sole inventor.

Major nutraceuticals programme
Project leader for six of ten herbals for a major outside client. Led six teams in 
fractionation for bio-directed assay and isolation of actives over a seven-month 
period. The products were commercially available less than 12 months after 
development.

Paclitaxel crystallization sequence
Chief inventor of four steps in this major pharmaceutical process. Coordinated 
research and development of all four steps to pilot and production. Recovery 
increased 80% over 2nd generation process. Rework reduced by 85%. Process cost reduced by 42%. Savings of several million dollars over 2nd generation process.

Nutraceutical isolation schemes
Primary inventor of 14 innovative, non-chromatographic purification processes for major nutraceutical products, such as anthocyanins from bilberry. Process patents pending. 

Developed crucial pharmaceutical purification step
Designed innovative filtration step for the third-generation Paclitaxel 
purification process. Collaborated in research and development of flush column and long column. Collaborated in structural elucidation of processing artifacts.

Computer modeling of chromatography and extraction
Developed liquid/liquid, HPLC, and bulk chromatography models capable of accurate modeling. Particularly useful in understanding scale-up from HPLC to prep-HPLC.

Innovated chromatography method using available media
Created homemade TLC plates from tech-grade powder, discovered good isolation of a pharmaceutical product. Modified available tech-grade granules by grinding, sieving, and solvent purification to isolate gram quantities of 95+% pure 
active compound using a one-meter normal-phase column.

Tocopherols from SDD
Primary inventor of simple, non-chromatographic process for isolation of pure mixed tocopherols from Soy Deodorizer Distillate.  Invention disclosure filed with U.S. Patents and Trademarks Office.  Project management authority.  Directed the work of one Ph.D. chemist and one entry-level chemist.

Coordinated the large-scale production of Michellamine B
Innovated scale-up procedures for a five-step isolation process, supervised two 
chemists and three technicians, collaborated in all research leading to production. 
Sole author of final report to the U.S. National Cancer Institute.

Innovative thermal analysis
Independently discovered concerted TGA/DSC/Microcalorimetry method of quantifying mixed hydrates. Cost reduction of several hundred thousand dollars per year in stabilizing solid phase detergents containing incompatible materials.

Formulation reverse engineering
Designed and analyzed experiments showing a physical chemical correlation to 
phosphate degradation in powder detergent. Reduced degradation 20%, annual savings of $120,000.

Nonionic surfactant titration
Close collaboration in development of a reliable, reproducible method of nonionic surfactant titration in real-world washwheel effluent samples from industrial and commercial laundries.

Wash sequence efficacy test
Developed first known in-washwheel test for wash sequence efficacy by simultaneous determination of soil load and surfactant concentration.  Useful to commercial and industrial laundry operations.

Functional textile accelerated aging test
Sole inventor of accelerated aging test for functional textiles (e.g. - reusable incontinence pads).  Model accurate for usage, laundering, drying, and storage. Applied as primary selection criterion for functional textiles by a major nursing home chain.  After several months, test was found to be accurate predictor.

Lycée-level advanced chemistry course
Designed an advanced summer school course, "L'Histoire de l'Atome", for several students at the premiere and terminale levels.  Taught the course in Sokodé, Togo, West Africa.

Synthesis of photochemical Truce-Smiles precursors
Under the direction of Prof. Dr. Gene Wubbels, synthesized and isolated potential precursors for use in photochemical Truce-Smiles rearrangement reactions.

Confirmation of adjusted Debye-Huckel
Original findings (Salt-solvent interactions in hydrogen peroxide reactions) were confirmed by Raju et al. in Ind. J. Chem. and again at Grinnell College one year later.

Laboratory assistantship
Second Freshman in history of Grinnell College to serve as a laboratory assistant.

Salt-solvent interactions in hydrogen peroxide reactions
Discovered new salt/solvent effects on degradation of hydrogen peroxide in the presence of halide salts.  Work suggested adjustments to the Debye-Huckel theory of solvent-electrolyte interactions.  This two-year research effort won two first-place awards at the International Science Fair in Anaheim, CA and was the basis for the conferring an honourary doctoral degree by the U.S. Air Force Systems Command, Wright-Patterson AFB, Dayton, OH.  Work was funded by IBM and the Mayo Clinic.

OTHER CAPABILITIES
___________________________________________________________________

Project management. Management and Supervisory capabilities in bench- and 
pilot-scale work. Stabilization of incompatible materials in final formulations. Extraction, including SPE, LLE, solvent, and trituration. Filtration, including membrane, depth, depth with body feed, and RDF. Chromatography, including HPLC, LPLC, MPLC, flash, and capture, in normal, reversed, mixed- and bio-modes of operation. Crystallization, non-chemical separations, hydrolytic conversions including enzymatic processing, and innovative process techniques. Method development in HPLC, photometry, and HTS analytical methodology. S Translation of technical articles from French. 

HazMat Capabilities 
Incident Command level evaluation and response.