華西亞生醫股份有限公司 www.vaxsia.com

31/03/2026

Announcing VADEX-Z and VADEX Club

22/04/2025

The new publication of our self-adjuvanted protein nanoparticle platform VADEX-Pro is published online on Vaccine already. Follow this link for full text: https://authors.elsevier.com/a/1kzU1,60n7vo56

This article is the basis of our future development of a universal vaccine platform. Please looking forward to it!

15/03/2025

The computer modeled structures of the VADEX polymerization peptide/self-adjuvant is available on modelarchive
AH3: https://www.modelarchive.org/doi/10.5452/ma-06g7k
AH3 dimer: https://www.modelarchive.org/doi/10.5452/ma-bhgiw
AH3 tandem tetramer: https://www.modelarchive.org/doi/10.5452/ma-xhrzb
LY monomer: https://www.modelarchive.org/doi/10.5452/ma-0koys
LY dimer: https://www.modelarchive.org/doi/10.5452/ma-7x5gd

RRLE monomer: https://www.modelarchive.org/doi/10.5452/ma-7x5gd
RRLE dimer: https://www.modelarchive.org/doi/10.5452/ma-ax78l
RRLE tetramer: https://www.modelarchive.org/doi/10.5452/ma-vyybf
LYRRLE monomer: https://www.modelarchive.org/doi/10.5452/ma-ivexo
LYRRLE dimer: https://www.modelarchive.org/doi/10.5452/ma-lptlj
LYRRLE tandem tetramer: https://www.modelarchive.org/doi/10.5452/ma-izbbn
LYRRLE inverted tetramer: https://www.modelarchive.org/doi/10.5452/ma-xomje

ModelArchive provides a stable accession code (DOI) for deposited theoretical models of protein and macromolecular structures

02/01/2025

抗體親和力極限的源起
抗體是脊椎動物兩種後天免疫反應的其中之一, 同時單株抗體也在現代醫藥中佔了極為重要的地位. 抗體作為脊椎動物抵抗外來病原的一種機制, 最主要的特點是抗體可以隨著病原體的不同而產生各種可與病原體結合並抑制其活性的特異性抗體. 已知的病原體有千百種, 脊椎動物是如何產生這麼多種類的特異性抗體呢? 其主要途徑有兩個, 第一個途徑是藉由基因重組: 在生成抗體多樣性的基因區塊中, 有三個由重複基因組成的片段小區, 分別命名為V, D和J小區, 在抗體生成的過程中, 經由基因重組過程中的VDJ排列組合和輕重鏈變化, 人體共可以產生3e11種不同蛋白序列的抗體. 第二個途徑則是發生在和抗原接觸後, 藉由這個特定區域隨機基因突變的機制, 以類似物競天擇的方式, 將和抗原結合的區域, 進行進一步的優化. 突變後結合力更好的抗體, 會得到免疫系統的獎勵, 使表現這些優質抗體的B細胞大幅增生. 而結合力不好的抗體, 就會被逐漸淘汰. 但是抗體的結合力是有極限的.
抗體的結合力可分為兩方面:締合常數(ka)和解離常數(kd). 締合常數是衡量抗體和抗原之間相互結合時所需要的時間和蛋白濃度, 其數值單位為”每秒莫耳”(s-1M-1). 由於締合常數受到分子擴散速度的限制, 因此學界公認抗原和抗體之間的締合常數極限值為1e6每秒莫耳. 而解離常數是計算讓半數抗原/抗體複合物解離開所需要的時間, 其使用單位是每秒(s-1). 抗原抗體之間的解離常數主要是受到內吞作用時程的限制. 因為在B細胞表面的抗體, 和抗原結合後會激發訊息傳遞, 造成這株B細胞的增生. 解離常數越低的抗體, 和抗原結合的時間越長, 也更能刺激細胞增生. 但是由於內吞作用會將抗原/抗體複合物送進細胞內分解, 中止訊息傳遞. 而內吞作用有固定的時程, 因此半數解離的時間遠高於內吞作用時程的A抗體和另一個半數解離時間等於內吞作用時程的B抗體相比, 並不具有更高的細胞增殖優勢. 因此正常狀況下解離常數的極限值受限於內吞作用速率, 其數值為1e-4 s-1.
因此目前學界公認的抗體的締合常數及解離常數極限分別為, 1e6每秒莫耳及1e-4 每秒. 因為抗體親和力的定義為:
解離常數/締合常數, 1e-4每秒/ 1e6每秒莫耳=1e-10莫耳. 所以在正常狀態下, 經由免疫接種所產生的總體抗體親和力極限為1e-10莫耳. 而藉由VADEX-pro平台免疫所產生的總體抗體親和力可以打破學界所認定的抗體親和力極限, 達到1e-12莫耳, 或是更低.
[1, 2]
參考文獻
1. Foote, J. and H.N. Eisen, Breaking the affinity ceiling for antibodies and T cell receptors. Proc Natl Acad Sci U S A, 2000. 97(20): p. 10679-81.
2. Batista, F.D. and M.S. Neuberger, Affinity dependence of the B cell response to antigen: a threshold, a ceiling, and the importance of off-rate. Immunity, 1998. 8(6): p. 751-9.

16/12/2024

Patent protection measures for process patents in major European and American countries
The enforcement of patent rights is to obtain the commercial benefits obtained by exclusively implementing the patented technology by excluding third parties from using the patented technology. When it is discovered that a third party is using the patented technology, the patentee can take legal action claiming patent rights, prohibit the infringer from using the patent, or prohibit the sale of the infringing products in the country where the patent rights were obtained, and demand compensation for damages. But how to obtain the evidence required to file infringement litigation? There are two main subjects of protection, one is the subject matter and the other is the process patent. The patentee of the infringed subject matter bear the burden of proof for evidence of subject matter patent infringement. However, for patents on manufacturing process, it is impossible to know the actual manufacturing method of the infringer, so it is often difficult to obtain relevant evidence.
Therefore, Article 34 of the TRIPs agreement signed by various countries when they joined the WTO urges the signatory countries to establish relevant laws to protect process patents, and specifically requires that the burden of proof for manufacturing process patents be shifted to the infringing defendant to provide evidence to prove that its manufacturing process does not violate the process patent in litigation. Currently, major scientific and technological countries such as the United States, European countries, Japan, and South Korea have established relevant laws of shifting the burden of proof to the infringer during manufacturing process patent infringement litigation. So as to protect the rights of the process patent owner.

15/12/2024

歐美主要國家對於製造方法專利之專利權保護措施
專利權的實施是藉由排除第三方使用獲得專利保護的技術,來得到經由獨家實施專利保護技術所取得的商業利益.當察覺有第三方利用該專利技術時, 專利所有權人可經由法律訴訟途徑主張專利權, 禁止該侵權者使用該專利, 或是禁止涉及侵權的產品在取得專利權的國家販售, 並要求損害賠償. 但是提起侵權法律訴訟所需的證據, 該如何取得呢? 專利所保護的主體主要有兩種, 一個是物,另一個是製造方法. 物的專利侵權需由專利所有權人提出侵權的相關證據. 但是對於製造方法的專利, 由於無法得知侵權者的實際製造方法, 因此通常難以取得相關證據. 因此在各個國家加入世貿組織時所簽署的TRIPs agreement Article 34中有敦促簽約國訂立保護方法專利的相關法律, 特別要求將製造方法專利的舉證責任, 轉由侵權被告提供證據證明其製造方法並未侵權.目前美國, 歐洲國家, 日本, 韓國等主要科技大國, 都採用在製造方法專利侵權訴訟中, 將舉證責任轉嫁於侵權人的方式. 以達到保護專利所有人權利的目的.
感想:台灣也應該修法, 向科技大國看齊, 才能達到鼓勵技術創新, 保護智慧財產權的目的.
#舉證責任轉換 #製造方法專利 #專利侵權

13/12/2024

單株抗體親和力和治療效果的關係.
單株抗體的親和力關係著以此單株抗體作為藥物使用時的治療效果. 抗體親和力由兩部分組成, 結合速率(ka)和解離速率(kd). 結合速率高則表示即使在抗體濃度低的狀態下, 也能很快地和抗原結合. 所以結合速率越高越好. 解離速率則是代表抗體和抗原結合後, 解離開來的速率. 一般以秒來作單位, 代表一半的抗體抗原結合物解離開來所需的時間. 這個解離速率越慢, 代表抗體抗原之間的結合越緊密, 不容易分開. 綜合兩者, 結合速率(ka)除以解離速率(kd)的數值則是親和力(KD), 代表結合與解離速率達到平衡時的所需的抗體濃度. 這個數值越低, 代表抗體越有效. 附圖是現有國際醫藥市場上銷量前20名藥物中的抗體藥物及其親和力的比較表. 有黃標的兩種抗IL-23藥物, 因為抗體親和力不同, 影響到藥物的治療效果.
華西亞生醫的VADEX-pro技術, 可以讓抗體親和力降低到1x10的負12次方(M). 可提高抗體治療效果同時降低抗體使用量.

06/12/2024

技術的進步沒有專利的保護只會形成產業的紅海. 華西亞生醫已經將VADEX-pro技術申請專利, 將來只有取得授權的商品才能在專利保護地區銷售, 來防止不肖廠商的惡性競爭. 此類商品包含具有超高親和力的單株抗體(KD

06/12/2024

New VADEX patent application filed!
We had filed patent application to protect our intellectual advancement in the tool for Biologic discovery. The well crafted VADEX-pro technology has shown its potential as the essential technology for generating and screening of Ultra-High affinity (KD

20/09/2024

Our first publication of VADEX platform is featured in Vaccine MDPI for been highly accessed.

A thermally stable vaccine platform is considered the missing piece of vaccine technology. In this article, we reported the creation of a novel protein nanoparticle and assessed its ability to withstand extended high temperature incubation while stimulating a long-lasting humoral immune response. Th...