EDUCATION:
CONTINUING
EDUCATION:
| 1998 |
|
Quality
Assessment of GLP Contract Laboratories, PDA, Durham,
NC |
| 1996 |
|
Cleaning
Validation Strategies and CIP Integration: ISPE, Rockville,
MD |
| 1996 |
|
High
Purity Water, Advanced: ISPE, Rockville, MD |
| 1995 |
|
Principles
of Validation: International Society for Pharmaceutical
Engineering, Rockville, MD |
| 1993-1994 |
|
CBER
Reviewer Training for: Regulation of Biologics; IND Issues,
PLA and ELA process; Postmarketing Regulations; Inspector
Training, FDA/CBER |
| 1993 |
|
Validation
of Sterile Processes for the Pharmaceutical Industry:
Institute for Applied Technology, San Francisco, CA |
| 1989 |
|
Advanced
Drug and Biologics Law: Staff College of the Center for
Drug Evaluation and Research, Bethesda, MD |
| 1989 |
|
Basic
Drug and Biologics Law: Staff College of the Center for
Drug Evaluation and Research, Bethesda, MD |
| 1988 |
|
Biological
Research HPLC: Waters Corporation, Milford, MA |
| 1966 |
|
Immunogenetics:
Graduate Program at NIH Foundation for Advanced Education
in the Sciences, Bethesda, MD |
| 1966 |
|
Virology:
Graduate Program at NIH Foundation for Advanced Education
in the Sciences, Bethesda, MD |
| 1965 |
|
Immunology:
Graduate Program at NIH Foundation for Advanced Education
in the Sciences, Bethesda, MD |
HONORS
AND AWARDS:
| 1994 |
|
FDA
Group Recognition Award |
| 1993 |
|
FDA
Group Recognition Award |
| 1990 |
|
FDA
Commendable Service Award |
| 1989 |
|
FDA
Commissioners Medallion |
EXPERIENCE:
CURRENT
POSITION: |
Vice
President, Audits & Inspections, Biologics Consulting
Group, Inc., Monrovia, MD. |
1997
to
present |
|
| |
|
| 1993
to 1997 |
Reviewer/Inspector,
Division of Establishment Licensing, Center for Biologics
Research and Review, FDA, Bethesda, MD. |
| |
- Chairperson
of 50+ review committees for establishment submissions.
- Responsible
for complete review of establishment applications
and supplements associated with vaccines, monoclonal
antibodies, allergenic extracts, in-vitro diagnostic
test kits and plasma fractionation.
- Additional
review experience as committee member for other establishment
license applications and supplements as well cross-over
member on product license applications and supplements.
- Reviewed
Master Files.
- Lead
inspector for prelicense and biennial CBER inspections.
CBER inspector 1990-1997.
- Instructor
for courses in product and process controls, and the
changing role of inspections, as part of CBER’s
reviewer training program.
- Member
of the CBER HVAC committee for the development and
publication of guidelines to assist applicants in
addressing establishment issues.
- Coordinated
and conducted meetings with regulated industry and
other sponsors of biologic products regarding issues
pertaining to pending or prospective establishment
applications. Provided guidance and interpretation
of applicable regulations and guidelines.
- Consultant
to product and application divisions regarding establishment
issues.
- Advisor
to CBER Office of Compliance regarding establishment
issues as related to inspections.
- Member
of the committee for development and publication of
guidance for industry in the preparation of the CMC
section of the proposed BLA for allergenic extracts.
- Member
of the committee for development and publication of
guidance for industry in the preparation of the ELA
section of proposed BLAs for various products.
- Comprehensive
knowledge of established and evolving regulations,
guidelines and policies involving facilities and cGMPs.
|
| |
|
| 1985
to 1993 |
Research
Biologist, Laboratory of Allergy and Immunochemistry
(LAI), Division of Bacterial Products (DBP), Center for
Biologics Research and Review, FDA, Bethesda, MD. |
| |
- Responsible
for development and certification of assays for selection,
isolation and characterization of hybridoma cell lines
for monoclonal antibody production
- Developed
a standard CHO cell assay protocol for monitoring
pertussis toxoids for toxins, and defined detection
limits for preservatives and other cytotoxic agents.
- Trained
U.S. and foreign scientists in the assay methodology.
- Inspection
of CBER licensed facilities.
- Review
of ELA supplements for allergenic extracts
|
| |
|
| 1981
to 1985 |
Research
Biologist, Laboratory of Cellular Physiology, Division
of Bacterial Products, Center for Biologics Research and
Review, FDA, Bethesda, MD. |
| |
- Responsible
for all aspects of production of hybridoma cell lines.
|
| |
|
| 1972
to 1981 |
Research
Biologist, Division of Pathology, Bureau of Biologics,
FDA, Bethesda, MD. |
| |
- Development
and characterization of unique cell lines for the
detection, isolation and reproduction of selected
viruses.
- Development
of substrate and test systems with increased sensitivity
for detection of bovine viruses.
- Investigation
into mechanisms by which viral contamination of substrates
could carry over to viral vaccines.
- Development
of a rapid detection system for viral infection of
cell cultures via immunoflorescense.
- Development
of a system for elimination of bacteriophage from
fetal bovine serum via affinity chromatography.
|
| |
|
| 1964
to 1972 |
Research
Biologist, Laboratory of Virology and Rickettsiology,
Division of Biologics Standards, NIH, Bethesda, MD. |
PROFESSIONAL
SOCIETIES:
CERTIFICATIONS
AND AUTHORIZATIONS:
| Nov.
6, 1999 |
|
Regulatory
Affairs Certified (RAC) |
| May
24, 1993 |
|
FDA
Certified Regulatory Inspector of Licensed Manufacturers
of Biologic Products. |
| 1993 |
|
FDA
Regulatory Reviewer, Biologics Establishment & Product
License applications. |
| 1991 |
|
FDA
Certified Regulatory Inspector of Licensed Manufacturers
of Biologic Products. |
PUBLICATIONS:
1) |
Probst,
PG, Orr, HC. (1970 Short-Term Storage at 4C of Trypsinized
Tissues. Applied Microbiology 19 #2: 387-388. |
2) |
Montes
de Oca, H, Probst, PG, Grubbs, R. (1971) High Yield Method
for Dispersing Simian Kidneys for Cell Cultures.
Applied Microbiology 20 #1 90-94. |
3) |
Probst,
PG, Rogers, JL, Orr, HC. (1972) A Cradle for Support of
Roller-Bottle Cell Cultures during Microscopic Examination.
Biotechnology & Bioengeneering XIV: 505-507. |
4) |
Orr,
HC, Harris, LE, Bader, AV, Kirschstein, RL, Probst, PG.
(1972) Cultivation of Cells from a Fibroma in a Rattlesnake, Crotalus horridus. J Nat Cancer Inst 48:
259-264. |
5) |
Orr,
HC, Probst, PG, Rogers, JL, Davis, JP, Stocks, NP, Baker,
J. (1973) Derivation and Biologic Properties of Cell Lines
from Ophidian Tissues. J Nat Cancer Inst 51: 827-832. |
6) |
Chu,
FC, Johnson, JB, Orr, HC, Probst, PG, Petricianni, JC.
(1973) Bacterial Virus Contamination of Fetal Bovine Sera.
In Vitro 9: 31-34. |
7) |
Orr,
HC, Probst PG, Littlejohn, DC, Chu, FC, Petricciani, JC.
(1974) Persistance of Bacteriophages in Experimentally
Infected Cell Cultures. ASM 27 #2: 1105-1107. |
8) |
Orr,
HC, Sibinovic, KH, Probst PG, Hochstein, DC, Littlejohn,
DC. (1975) Bacteriological Activity in Unfiltered Calf
Sera Collected for Tissue Culture Use. In Vitro 11 #4: 230-233. |
9) |
Orr,
HC, Weetall, HH, Probst, PG, Littlejohn, DC, Chu, FC,
Johnson, JB, Petricciani, JC. (1976) Elimination of Bacteriophages
from Tissue Culture Serum By Affinity Chromatography.
ASM 3 #4: 402-405. |
10) |
Carter,
PH, Orr, HC, McGrath, PP, Probst, PG. (1978) Virus Like
Particles in WI-38 Cells Infected with Bovine Viral Diarrhia
Virus. W Alton Jones Cell Science Center Symp. Lake Placid,
NY. Oct 23-26. [Abstract]. |
11) |
Weetall,
HH, Luderer, AA, Orr, HC, Probst, PG. (1979) Rapid Immunoflourescent
Detection of Viral Infection In Tissue Culture. Immunology
Letters 1: 11-13. |
12) |
Kenimer,
JG, Kim, KJ, Probst, PG, Manclark, CR, Burstyn, DG, Cowell,
JL. (1989) Monoclonal Antibodies to Pertussis Toxin: Utilization
as Probes of Toxin Function. Hybridoma 8: 37-51. |
13) |
Chandler,
DKF, Olson, LD, Kenimer, JG, Probst, PG, Rottem, S, Grabowski,
MW, Barile, ME. (1989) Antibodies to Mycoplasma pneumoniae Membrane Glycolipids. Infec and Immun. 57:1131-1136. |
14) |
Elizabeth
Leininger, Peter G. Probst and James G. Kenimer (1990)
Characterization of Monoclonal Antibodies Against the Bordetella pertussis Adhesin Filimentous Hemagglutinin.
The 6th International Symposium on Pertussis. Bethesda,
MD. Sept 26-28. [Abstract]. |
15) |
Rouse,
DA, Morris, SL, Karpas, AB, Probst, PG, Chaparas, SD.
(1990) Production, Characterization, and Species Specificity
of Monoclonal Antibodies to Mycobacterium avium Complex Protein Antigens. Infec and Immun. 58:
1445-1449. |
16) |
Olson,
LD, Shane, SW, Karpas, AB, Cunningham, TW, Probst, PG,
Barile, MF. (1991) Monoclonal Antibodies to Surface Antigens
of a Pathogenic Mycloplasma hominis Strain. Infec.
and Immun. 59: 1683-1689. |
17) |
Rouse,
DA, Morris, SL, Karpas, AB, Mackall, JC, Probst, PG, Chaparas,
SD. (1991) Immunological Characterization of Recombinant
Antigens Isolated from a Mycobacterium avium lambda
gt11 Expression Library by Using Monoclonal Antibody Probes.
Infec and Immun 59: 2595-2600. |
18) |
Nancy
A. Roscioli, Carolyn A. Renshaw, Alicia A. Gilbert, Cristina
F. Kerry, and Peter G. Probst. (1996) Environmental Monitoring
Considerations for Biological Manufacturing. BiioPharm 8 No. 9: 32-40. |
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Updated:
June 16, 2008
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