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？
|
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。
|
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。
|
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？
|
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？
|
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？
|
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.
|
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
:
|
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
:
|
