w*****q 发帖数: 2 | 1 做biosimilar的公司怎么知道一个蛋白的具体gene序列呢?专利上里有吗?如果有,那
做biosimilar的公司真是拣一大便宜啊。
查了几个,发现paper里的序列上都多少有点出入,到底以什么为准呢? |
b******e 发帖数: 3348 | 2 知道同样的序列和做出同样的蛋白是完全不同的事。
【在 w*****q 的大作中提到】 : 做biosimilar的公司怎么知道一个蛋白的具体gene序列呢?专利上里有吗?如果有,那 : 做biosimilar的公司真是拣一大便宜啊。 : 查了几个,发现paper里的序列上都多少有点出入,到底以什么为准呢?
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w*****q 发帖数: 2 | 3
但是不一样的序列更做不出一样的蛋白吧。
【在 b******e 的大作中提到】 : 知道同样的序列和做出同样的蛋白是完全不同的事。
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b******e 发帖数: 3348 | 4 Are you sure?
【在 w*****q 的大作中提到】 : : 但是不一样的序列更做不出一样的蛋白吧。
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b******1 发帖数: 1116 | 5 For Biosimilar, process is the prodcut... slightly different gene sequence
does not matter. |
A*N 发帖数: 1128 | 6 And even how do you confirm "the identical", not straightforward
知道同样的序列和做出同样的蛋白是完全不同的事。
【在 w*****q 的大作中提到】 : 做biosimilar的公司怎么知道一个蛋白的具体gene序列呢?专利上里有吗?如果有,那 : 做biosimilar的公司真是拣一大便宜啊。 : 查了几个,发现paper里的序列上都多少有点出入,到底以什么为准呢?
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e********r 发帖数: 353 | 7 如果查不到,做个蛋白测序即可,
【在 w*****q 的大作中提到】 : 做biosimilar的公司怎么知道一个蛋白的具体gene序列呢?专利上里有吗?如果有,那 : 做biosimilar的公司真是拣一大便宜啊。 : 查了几个,发现paper里的序列上都多少有点出入,到底以什么为准呢?
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N******o 发帖数: 25 | 8 The sequence should be identical to the originator's. Otherwise, don't even
think about it's a biosimilar.
Read through recently published FDA guideline draft if you are interested in
this area.
【在 w*****q 的大作中提到】 : 做biosimilar的公司怎么知道一个蛋白的具体gene序列呢?专利上里有吗?如果有,那 : 做biosimilar的公司真是拣一大便宜啊。 : 查了几个,发现paper里的序列上都多少有点出入,到底以什么为准呢?
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J****a 发帖数: 553 | 9 By my understanding, the DNA or amino acid sequence of the biosimilar
product need not be identical to the innovator product for a finding of
biosimilarity under the statute.There may be advantages to using a different
gene sequence that encodes the same protein.
"In general, FDA expects that the expression construct for a proposed
product will encode the same primary amino acid sequence as the reference
product. However, minor modifications such as N- or C-terminal truncations
that will not affect safety and effectiveness may be justified and should be
explained by the sponsor." --Guideline page 9
even
in
【在 N******o 的大作中提到】 : The sequence should be identical to the originator's. Otherwise, don't even : think about it's a biosimilar. : Read through recently published FDA guideline draft if you are interested in : this area.
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N******o 发帖数: 25 | 10 I guess it's OK to have different gene sequence, but final protein sequence
has to be identical, as FDA mentioned. Minor mofification generally referers
to post-translation modification, including glycosylation, C-terminal Lys
truncation for mAb. FDA does gives small rooms for those known modifications
, especially glycosylation. Those have to be justifitable based on bioassay,
preclinical, even clinical data.
Overall, I believe no sequence variation acceptable in term of biosimilar.
different
be
【在 J****a 的大作中提到】 : By my understanding, the DNA or amino acid sequence of the biosimilar : product need not be identical to the innovator product for a finding of : biosimilarity under the statute.There may be advantages to using a different : gene sequence that encodes the same protein. : "In general, FDA expects that the expression construct for a proposed : product will encode the same primary amino acid sequence as the reference : product. However, minor modifications such as N- or C-terminal truncations : that will not affect safety and effectiveness may be justified and should be : explained by the sponsor." --Guideline page 9 :
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e********r 发帖数: 353 | 11 如果用不同的基因序列去表达相同的氨基酸,还需要考虑code usage的影响。
different
be
【在 J****a 的大作中提到】 : By my understanding, the DNA or amino acid sequence of the biosimilar : product need not be identical to the innovator product for a finding of : biosimilarity under the statute.There may be advantages to using a different : gene sequence that encodes the same protein. : "In general, FDA expects that the expression construct for a proposed : product will encode the same primary amino acid sequence as the reference : product. However, minor modifications such as N- or C-terminal truncations : that will not affect safety and effectiveness may be justified and should be : explained by the sponsor." --Guideline page 9 :
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