Delving into the Latest Updates on CSL Behring (Australia) Pty Ltd. with Synapse

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Other Diseases

Hemic and Lymphatic Diseases

Congenital Disorders

Immunoglobulin

Biological products

AAV based gene therapy

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

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Targets

Most frequently developed targets

Disease Domain	Count

Hemic and Lymphatic Diseases	4
Immune System Diseases	2
Infectious Diseases	1

Top 5 Drug Type	Count

Immunoglobulin	2
AAV based gene therapy	1
Recombinant coagulation factor	1
Biological products	1
Blood components	1

Top 5 Target	Count

Tetanus toxin	1
factor IX(Coagulation factor IX)	1
C1-INH(serpin family G member 1)	1
ELA2(Leukocyte elastase)	1
Immunoglobulin x Rh factor	1

Introduction Four-factor prothrombin complex concentrate (4F-PCC) is recommended for vitamin K antagonist reversal in patients with major bleeding or in need of surgery. The most important risk associated with the use of 4F-PCC is the occurrence of thromboembolic events (TEEs). In this review, we aim to evaluate the safety profile of a 4F-PCC (Kcentra®/Beriplex® P/N; CSL Behring, Marburg, Germany) by reviewing pharmacovigilance data. Methods A retrospective analysis of postmarketing pharmacovigilance data of Kcentra®/Beriplex® P/N from February 1996 to April 2022 was performed and complemented by a review of clinical studies published between January 2012 and April 2022. Results A total of 2,321,443 standard infusions of Kcentra®/Beriplex® P/N were administered during the evaluation period. Adverse drug reactions (ADRs) were reported in 614 cases (∼1 per 3,781 standard infusions) and 233 of these cases (37.9%) experienced suspected TEEs related to 4F-PCC (∼1 per 9,963 standard infusions); most of these cases had pre-existing or concomitant conditions likely to be significant risk factors for thrombosis. TEE rates were similar when 4F-PCC was used on-label or off-label for direct oral anticoagulant-associated bleeding. Thirty-six cases (5.9%) reported hypersensitivity type reactions (∼1 per 64,485 standard infusions). No confirmed case of viral transmission related to 4F-PCC use was reported. The published literature also revealed a favorable safety profile of 4F-PCC. Conclusion Analysis of postmarketing pharmacovigilance safety reports demonstrated that treatment with 4F-PCC was associated with few ADRs and a low rate of TEEs across multiple indications and settings, thus confirming a positive safety profile of 4F-PCC.

03 Sep 2017·Journal of Immunoassay and Immunochemistry

Improvement of ELISA procedures through simultaneous addition of antigen and detection antibody and elimination of washing steps

Article

Author: Bertolini, J. ; Gurevich, V. ; McCann, K. ; Kotharu, P.

The enzyme-linked immunosorbent assay (ELISA) is extensively used for measurement of proteins utilized for various research and diagnostic purposes in the biological disciplines. However, it is a labor-intensive and lengthy procedure due to a number of incubation and washing steps required for performing the assay. The ELISA procedure in the current study has been simplified through the simultaneous addition of antigen and detection antibody and elimination of washing steps. This resulted in a decreased time required to perform the procedure and without affecting assay capability. This approach offers the possibility of increasing ELISA productivity in low throughput laboratories without the need for alternative analytical platforms which would require significant assay redevelopment and capital expense.

03 Aug 2017·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Rubella antibodies in Australian immunoglobulin products

Q3 · MEDICINE

Article

Author: Bertolini, Joseph ; Young, Megan K. ; Kotharu, Pushpa ; Maher, Darryl ; Cripps, Allan W.

Rubella antibodies are not routinely measured in immunoglobulin products and there is a lack of information on the titer in Australian products. To facilitate future studies of the effectiveness of passive immunisation for preventing rubella and congenital rubella syndrome, this study measured the concentration of rubella-specific antibodies in Australian intramuscular (IM) and intravenous (IV) human immunoglobulin products suitable for post-exposure prophylaxis using a chemiluminescent immunoassay. The GMT ± GSD for the IM product was 19 ± 1.2 IU/mg (2980 ± 1.2 IU/mL). The GMT ± GSD for the IV product was 12 ± 1.5 IU/mg (729 ± 1.5 IU/mL). At present, Australian guidelines recommend offering non-immune pregnant women exposed to rubella 20 mL of intramuscular immunoglobulin within 72 hours of exposure. This equates to 42,160 IU of rubella antibodies if the lowest titer obtained for the Australian IM product is considered. The same dose would be delivered by 176 mL of the Australian IV product at the lowest measured rubella-specific antibody titer.

100 Deals associated with CSL Behring (Australia) Pty Ltd.

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100 Translational Medicine associated with CSL Behring (Australia) Pty Ltd.

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Pipeline

Pipeline Snapshot as of 23 Jan 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Approved

6

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Etranacogene dezaparvovec ( factor IX )	Hemophilia B More	Approved
Fibrinogen (Liminal BioSciences)	Afibrinogenemia More	Approved
Rh immunoglobulin-VF ( Immunoglobulin x Rh factor )	Hematologic Diseases More	Approved
Alpha-1-Proteinase Inhibitor (Human)(CSL Behring) ( ELA2 )	Emphysema More	Approved
C1 Esterase Inhibitor (Human) ( C1-INH )	Hereditary Angioedema More	Approved