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Project Main Details
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Budget range $425 - $637.
Jan 23, 2007 08:22:28 (GMT -05:00) Eastern Time (US & Canada) Jan 26, 2007 00:00:00 (GMT -05:00) Eastern Time (US & Canada) No (click here to learn more about
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Script Details
Worldwide there are over ten million new cases of cancer and over six million cancer-related deaths every year
The most commonly occurring cancers, Lung, Colorectal, and Breast account for over a third of all new cancer cases.
Currently, for many cancers detection at an advanced stage implies a poor prognosis.
This unmet medical need requires new therapies to improve patient outcomes.
Despite the use of the best available chemotherapy agents, patient outcome remains poor in advanced stages of cancer.
Significant hope to improve patient outcome came through the new targeted therapies, such as BBB.
BBB® is the first, approved IgG1 monoclonal antibody specifically targeting the epidermal growth factor receptor (EGFR).
BBB was developed over a period of about 25 years.
The early development of BBB began around 19xx in the research laboratory of Dr. CCC and Dr. DDD in the University ZYX.
Since 1996, CCC is president of the University of XYZ.
For almost three decades, Dr. CCC has been at the forefront in research on how growth factors regulate the proliferation of cancer cells.
Blocking of the EGFR by BBB® results in the inhibition of tumor growth, tumor invasion, metastasis, DNA damage repair, angiogenesis.
Monoclonal antibodies are known as ‘biopharmaceuticals’. Biopharmaceuticals are produced using biological processes instead of chemical synthesis. Injecting a specific antigen into mice stimulates their immune system to produce the corresponding antibody. Spleen cells are then taken from mice and fused with special, fast-growing immortal cells to make ‘clone cells’. One clone cell line is then selected to be used for further production of the monoclonal antibody.
This cell line is stored in liquid nitrogen and is the basis for all further product manufacturing.
To produce the antibody in large amounts, the clone cells are grown in aqueous culture medium over multiple steps. The cell suspensions are expanded from small 25 mL cell culture bottles up to over 10.000 L fermenters. This process takes a number of weeks.
The product generated by the cells – the monoclonal antibody – is then extracted over several purification steps.
BBB has to be stored at 2 to 8 degrees Celsius.
The product is filled in vials under sterile conditions. This process involves a machine that washes and dries the vials in several cycles before reaching the bottling station.
Here, the bulk product is filtered directly into vials under sterile conditions, locked by a plug and sealed.
The vials are packed into boxes by hand and then undergo a visual safety check. Each individual vial is thoroughly examined against a 20 point check list, and the results are precisely documented. The staff involved in the safety checks all undergo specific training. Once the control team approves the batch, the product is labeled and packaged.
The BBB label includes important information such as the batch number and expiry date. A conveyor belt transports the labeled vials to the packaging station where they are placed in cardboard boxes together with the package inserts.
All boxes are weighed to ensure there is nothing missing. Finally, they are film-wrapped in packs of five and prepared for shipping.
The BBB that is used in clinical studies is produced at AAA’s headquarters in ZZZ.
BBB represents an important advance in cancer therapy.
It is generally well tolerated and when used in combination, BBB does not increase the side-effects commonly seen with chemotherapy alone.
BBB is the first targeted therapy approved for the treatment of metastatic colorectal cancer (mCRC) in patients after failing prior irinotecan-based therapy.
BBB has already been granted market authorization for this indication in many countries e.g. in Europe, the U.S., Latin America and Asia
Additionally, BBB is approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN) where it has demonstrated a significant survival benefit when combined with radiotherapy compared to radiotherapy alone.
Thousands are diagnosed with cancer every year.
With studies ongoing in several additional indications, BBB is set to offer hope and revolutionize the way cancer is treated.
Corpoarte video Budget range $425 - $637.
Worldwide there are over ten million new cases of cancer and over six million cancer-related deaths every year
The most commonly occurring cancers, Lung, Colorectal, and Breast account for over a third of all new cancer cases.
Currently, for many cancers detection at an advanced stage implies a poor prognosis.
This unmet medical need requires new therapies to improve patient outcomes.
Despite the use of the best available chemotherapy agents, patient outcome remains poor in advanced stages of cancer.
Significant hope to improve patient outcome came through the new targeted therapies, such as BBB.
BBB® is the first, approved IgG1 monoclonal antibody specifically targeting the epidermal growth factor receptor (EGFR).
BBB was developed over a period of about 25 years.
The early development of BBB began around 19xx in the research laboratory of Dr. CCC and Dr. DDD in the University ZYX.
Since 1996, CCC is president of the University of XYZ.
For almost three decades, Dr. CCC has been at the forefront in research on how growth factors regulate the proliferation of cancer cells.
Blocking of the EGFR by BBB® results in the inhibition of tumor growth, tumor invasion, metastasis, DNA damage repair, angiogenesis.
Monoclonal antibodies are known as ‘biopharmaceuticals’. Biopharmaceuticals are produced using biological processes instead of chemical synthesis. Injecting a specific antigen into mice stimulates their immune system to produce the corresponding antibody. Spleen cells are then taken from mice and fused with special, fast-growing immortal cells to make ‘clone cells’. One clone cell line is then selected to be used for further production of the monoclonal antibody.
This cell line is stored in liquid nitrogen and is the basis for all further product manufacturing.
To produce the antibody in large amounts, the clone cells are grown in aqueous culture medium over multiple steps. The cell suspensions are expanded from small 25 mL cell culture bottles up to over 10.000 L fermenters. This process takes a number of weeks.
The product generated by the cells – the monoclonal antibody – is then extracted over several purification steps.
BBB has to be stored at 2 to 8 degrees Celsius.
The product is filled in vials under sterile conditions. This process involves a machine that washes and dries the vials in several cycles before reaching the bottling station.
Here, the bulk product is filtered directly into vials under sterile conditions, locked by a plug and sealed.
The vials are packed into boxes by hand and then undergo a visual safety check. Each individual vial is thoroughly examined against a 20 point check list, and the results are precisely documented. The staff involved in the safety checks all undergo specific training. Once the control team approves the batch, the product is labeled and packaged.
The BBB label includes important information such as the batch number and expiry date. A conveyor belt transports the labeled vials to the packaging station where they are placed in cardboard boxes together with the package inserts.
All boxes are weighed to ensure there is nothing missing. Finally, they are film-wrapped in packs of five and prepared for shipping.
The BBB that is used in clinical studies is produced at AAA’s headquarters in ZZZ.
BBB represents an important advance in cancer therapy.
It is generally well tolerated and when used in combination, BBB does not increase the side-effects commonly seen with chemotherapy alone.
BBB is the first targeted therapy approved for the treatment of metastatic colorectal cancer (mCRC) in patients after failing prior irinotecan-based therapy.
BBB has already been granted market authorization for this indication in many countries e.g. in Europe, the U.S., Latin America and Asia
Additionally, BBB is approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN) where it has demonstrated a significant survival benefit when combined with radiotherapy compared to radiotherapy alone.
Thousands are diagnosed with cancer every year.
With studies ongoing in several additional indications, BBB is set to offer hope and revolutionize the way cancer is treated.
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