Dear Mr. Breitfeller,
Your email was forwarded to us by CBER (this IND resides in the Center for Drugs Evaluation and Research). We have contacted BMS to check into the availability of ipilimumab and here is the information that BMS provided to us.
"To ensure treatment is not interrupted for patients currently receiving ipilimumab and to provide ongoing supply to the registrational program, Bristol-Myers Squibb and Medarex have suspended enrollment of new patients into the compassionate use program, single patient exemptions and initiation of some non-registrational trials effective September 12, 2008.
Bristol-Myers Squibb and Medarex are working to manage the supply issue and may be able to re-open compassionate use in the future.
The companies are committed to providing uninterrupted treatment to patients who initiate therapy with ipilimumab. Therefore, if and when the compassionate use program reopens, it will be at such time when continuous and unconstrained supply is available."
Please let us know if you have any questions.
Sincerely,
CDER Drug Shortage Team
Well, I did a little research!!!!! See I came from a background of using bioreactors for growing things like detergent enzymes, bacteria ..etc.
1990’s “Degradation of the Ferric Chelate of EDTA by a Pure Culture of an Agrobacterium sp”
John J. Lauff,1* D. Bernie Steele,2 Louise A. Coogan,1 and James M. Breitfeller1†
1Genencor International, 1870 Winton Road, South, Rochester, New York 14618, and Department of Botany and Microbiology, Auburn University, Auburn, Alabama 36899, 2
* Corresponding author.
† Present address: Analytical Technology Division, Eastman Kodak Co., Rochester, NY 14650.
So when Bristol Meyer Squibb contacted me this week and said that they are going to continue the ban on the compassionate use for Critically Ill Melanoma Patients, I was furious. They told me that they serviced 1400 compassionate patients before stopping the program.
So Lets do the Math!!!!!!!
1400 times 10 doses times 10mg/dose equals 140,000 mg or
Answer: 140000 mg = 140 grams of anti-CTLA-4 antibodies
0ne pound = 454 grams
That doesn’t seem like a lot. Are they using a small reactor vessel? I bet they are not.
Well I forgot to take into account the Patients bodyweight.
800 mg per dose, So about 8000 mg for 10 doses for a person weighing 175 lbs.
Thank for checking my math Jerry!!!!!!
So what does it entail to make these antibodies?
Source:http://www.sumanasinc.com/webcontent/animations/content/monoclonalantibodies.html
The making of Monoclonal Antibodies
Once you have them separated and frozen, and stored in cryogenic storage, all you have to do is to take some vials and inoculate your bioreactor with them. With the correct medium, temperature, pH and oxygen and nutrients, they begin to grow.
Figure 4. Comparison of first and second generation MTCM basal media for a HuMAb production using Expression System I.
“HuMAb batch processes with MTCM A and B were developed that can yield up to 1 g/L without feed addition. In general, MTCM B supports better cell growth and longevity of the culture, and as a result, leads to better productivity in batch and fed-batch processes. For example, Figure 4 shows that, cell culture processes in MTCM B not only reached higher peak cell density, but also expressed higher antibody levels for both batch and fed-batch compared to those in MTCM A.”
As you can see it does not take a year to produce these antibodies. Most likely they have quite a number of bioreactors. So when one reactor is down due to sterilization, they can start another run in the other one.
Source:http://biopharminternational.findpharma.com/biopharm/article/articleDetail.jsp?id=601146&sk=&date=&pageID=2
The Impact of Cell Culture Medium on Cell Line and Process Development Timelines and Strategies
So the Million dollar question is, Why did they stop the compassionate use program??
So I wrote back to them and said:
I find it hard to believe that your “process” is taking a year to get under control and be efficient. If it was FDA approved, and you were loosing capital, it would be under control by now. See, I am not your typical Patient. I worked in the Biosciences Industry for a number of years. You can’t sweep this under the table. There are Melanoma Patients dying. I am seeing it first hand. The blood is on your hands!!!!!!!
Your Company states: ” What sets us apart? We believe it's our commitment to patients with serious diseases, our focus on finding innovative medicines that combat those diseases, and our dedication to extending and enhancing human life.”
This is nice PR, but if you don’t walk the walk and it is all talk, then it means NOTHING!!!!!!! And the most ill Melanoma patients don’t have time on their side.
Take care
Jimmy B
Melanoma_Missionary
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