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FIVE MAIN AREAS OF RESEARCH
• Neurology:         MS, Parkinson’s disease
                     AVONEX® and TYSABRI®
                     Silence the inflammation

• Immunology:         Rheumatoid Arthritis
                      RITUXAN® ; IgG1kappa Ab – against CD20 Ag
• Oncology:           Non hodgkins lymphoma
                      RITUXAN® ; tergets CD20 Ag
• Hemophillia:        rFIXFc
                      Fc fused blood clotting factor
• Cardiopulmonary: ADENTRI® (Phase 2), Lixivaptan (phase 3)
                      A1 adenosine receptor antagonist.
                      address hyponatremia and renal failure.
PHASES               DRUGS
FDA APPROVED DRUGS
PHASE 1              ANTI-LINGO, NEBULASTIN, CD40L,
                     ANTI-TWEAK, BIIB037 (HUMAN
                     ANTI-AMYLOID B MAB)

PHASE 2              OCRELIZUMAB (HUMANIZED
                     ANTI-CD20 MAB).

PHASE 3              PEG IFN (PEGYLATED
                     INTERFERON BETA-1A), BG-12
                     (DIMETHYLFUMARATE),
                     DACLIZUMAB, LONG LASTING r
                     FACTOR IX, LONG LASING r
                     FACTOR VIII, GA101 (HUMANIZED
                     ANTI-CD20 MAB),
                     DEXPRAMIPEXOLE.
PHASE 4              -------
FILLING              -------
WORK DONE IN QUALITY ASSURANCE
 DEVELOPMENT, MAINTENANCE AND MANAGEMENT OF QUALITY SYSTEMS

 ENSURE THAT EXCEPTIONS ARE ANALYZED FOR PREVENTIVE ACTIONS AND
 PRODUCT IMPACT.

 DEVELOP AND MAINTAIN DATA ANALYSIS AND TRENDING SYSTEMS FOR PRODUCT
 SPECIFIC DATA GENERATED AT THE FACILITY.

 PROVIDE TECHNICAL EXPERTISE FOR PRODUCT QUALITY DECISIONS.

 MAINTAIN PRODUCT DISPOSITION PROCEDURES.

 EVALUATION OF FACILITY, PROCEDURES, EQUIPMENT, PERSONNEL AND
 PROCESSES.

PROCESSES USED
MASS SPECTROSCOPY: ESI TOF MS, MALDI MS,LC UV MS.

CHROMATOGRAPHY: HIC, RPLC, SEC, ION EXCHANGE CHROMATOGRAPHY,

SDS PAGE

cIEF

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Presentation1

  • 1. FIVE MAIN AREAS OF RESEARCH • Neurology: MS, Parkinson’s disease AVONEX® and TYSABRI® Silence the inflammation • Immunology: Rheumatoid Arthritis RITUXAN® ; IgG1kappa Ab – against CD20 Ag • Oncology: Non hodgkins lymphoma RITUXAN® ; tergets CD20 Ag • Hemophillia: rFIXFc Fc fused blood clotting factor • Cardiopulmonary: ADENTRI® (Phase 2), Lixivaptan (phase 3) A1 adenosine receptor antagonist. address hyponatremia and renal failure.
  • 2. PHASES DRUGS FDA APPROVED DRUGS PHASE 1 ANTI-LINGO, NEBULASTIN, CD40L, ANTI-TWEAK, BIIB037 (HUMAN ANTI-AMYLOID B MAB) PHASE 2 OCRELIZUMAB (HUMANIZED ANTI-CD20 MAB). PHASE 3 PEG IFN (PEGYLATED INTERFERON BETA-1A), BG-12 (DIMETHYLFUMARATE), DACLIZUMAB, LONG LASTING r FACTOR IX, LONG LASING r FACTOR VIII, GA101 (HUMANIZED ANTI-CD20 MAB), DEXPRAMIPEXOLE. PHASE 4 ------- FILLING -------
  • 3. WORK DONE IN QUALITY ASSURANCE DEVELOPMENT, MAINTENANCE AND MANAGEMENT OF QUALITY SYSTEMS ENSURE THAT EXCEPTIONS ARE ANALYZED FOR PREVENTIVE ACTIONS AND PRODUCT IMPACT. DEVELOP AND MAINTAIN DATA ANALYSIS AND TRENDING SYSTEMS FOR PRODUCT SPECIFIC DATA GENERATED AT THE FACILITY. PROVIDE TECHNICAL EXPERTISE FOR PRODUCT QUALITY DECISIONS. MAINTAIN PRODUCT DISPOSITION PROCEDURES. EVALUATION OF FACILITY, PROCEDURES, EQUIPMENT, PERSONNEL AND PROCESSES. PROCESSES USED MASS SPECTROSCOPY: ESI TOF MS, MALDI MS,LC UV MS. CHROMATOGRAPHY: HIC, RPLC, SEC, ION EXCHANGE CHROMATOGRAPHY, SDS PAGE cIEF