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YC Biotech
YC Biotech

éternel & qualité

  • About Us
    • About Our Founder
    • Our Team & Consultants
  • Our Services
    • Clinical and Preclinical Achievements
    • Clinical Services
    • Business Services
    • Elite Biotech Innovations
  • Biomedicine
    • Mesenchymal Stem Cells (MSCs)
    • Exosomes
    • Cell Therapy_Cytokine-Induced Killer Cells (CIK)
    • Cell Therapy_Dendritic Cells (DCs)
  • NEWs
  • Contact Us
  • 中文
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YC Biotech
YC Biotech

éternel & qualité

Search
  • About Us
    • About Our Founder
    • Our Team & Consultants
  • Our Services
    • Clinical and Preclinical Achievements
    • Clinical Services
    • Business Services
    • Elite Biotech Innovations
  • Biomedicine
    • Mesenchymal Stem Cells (MSCs)
    • Exosomes
    • Cell Therapy_Cytokine-Induced Killer Cells (CIK)
    • Cell Therapy_Dendritic Cells (DCs)
  • NEWs
  • Contact Us
  • 中文

What’s New in Biomedicine

Advancements in Biomedical Science

Cytokine-Induced Killer Cells (CIK)
Dendritic Cells (DCs)
Exosomes
Mesenchymal Stem Cells (MSCs)

地址：115臺北市南港區忠孝東路七段510號9F
E-mail：service@yuchunbiotech.com
Tel：+886-2-2695-1268

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Copyright © YC Biotech Co., Ltd.
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PROTOCOL DESIGN

The complexity and demands of protocols have increased in recent years.
That complexity is putting a burden on patients and investigators alike and can heavily impact patient enrollment rates.
Yet amending protocols mid-stream will noticeably increase the time and cost of the development program with no guarantee of outcome improvement.

Chemistry, Manufacturing and Controls (CMC)

All stages of the drug development life cycle, after drug discovery involve CMC.
During preclinical drug development, the proper analytical methods are validated to monitor the product. Stability testing may be initiated, the physicochemical properties of the product are determined, raw materials are chosen and tested.When the drug development process moves into the clinical stage, further analytical method validation is required, and additional characterization of the drug product is needed.
After clinical trials the scale-up process must ensure that the larger batches of product are the same and meet the same specifications as the drug tested in the clinical trials, and after the manufacturing process is qualified, lot release and in-process testing will continue to take place.

Pharmacodynamics (PD), Pharmacokinetics (PK), and Toxicokinetics (TK)

Non-clinical Pharmacodynamic (PD), Pharmacokinetic (PK) and toxicokinetic (TK) analyses are key activities of early drug development, but that does not mean their importance fades after Phase I initiation.
Extensive and formalized PD, PK and TK studies with GLP compliance form the basis of proving drug efficacy and continued success, as well as exploring possible different clinical approaches, such as the route of administration.

 

We can help streamline the process with:

  • PK Sample Analysis
  • Rapid PK Screening
  • ELISA Assays
  • Analysis of Optimal Dosing Regimen

Laboratory Solutions

Laboratory Solutions streamline research processes, offering tailored tools and services to enhance efficiency and quality. From sample analysis to data management, these solutions optimize workflows and drive innovation in drug development and clinical research.

Biostatistics

Biostatistics and offer more than statistical analyses. Our understanding of the science of disease and biologics, as well as knowledge of valuable upfront study design and comprehensive planning assistance.

Investigator payments/Contract management

Timely and accurate Investigator payments are critical for keeping sites motivated and driving site performance in a study. Study protocols have become more complex, and the invoice process and tax management for sites further complicates the task of making timely and accurate payments.

Patient Centered Services

It is critical to understand the needs and key decision-making considerations of the target patient population, as this understanding allows the leverage patient perspective to optimize feasibility, recruitment and retention.
This enables the development of highly effective, focused strategies that increase engagement throughout the patient’s journey.

Site Support/Startup

  • A clinical site requires a surprising amount of support that is not immediately evident. Its infrastructure needs to be documented to the satisfaction of regulatory authorities, and encompasses a wide array of subtopics, including equipment and information storage, system controls, blinding, data transparency, data sharing, record keeping, physical and digital security, technological capabilities, hiring processes, conflicts of interest, operational infrastructure, maintenance, among others.
  • Additional requirements include safety reporting, preventive and corrective actions, participant engagement, risk/benefit communication, informed consent, participant welfare, IRB approval.

Customized Solutions

All our solutions are built on the belief that everything should be agile and customized. Our products can always be quickly tailored to the demands at hand.

Regulatory Support

A regulatory plan devised early in product lifecycle is a powerful, strategic tool to preemptively identify key challenges that may arise, as well as a guideline for constant communication and interaction with relevant regulatory bodies.
Navigating this complex landscape ensures the investigational product aligns with regulatory and commercial requirements, but is far from easy.

Bioanalysis

Solid bioanalytic capabilities are indispensable when trying to obtain precise results, and precise results are precisely what regulatory bodies wish to see in a submission.

Screening & Profiling Assays

Assay development is an indispensable aspect of proving the validity of IND-enabling studies.
A custom assay, or an expert evaluation of your own assay before screening begins is a critical safeguard against denial from regulatory authorities.

Pharmacology & Toxicology Studies

Assessing drug profiles early in the development cycle is key to avoiding wasted research, and to progress from discovery stage through to IND stage, as toxicity is the primary reason a drug is not approved for Phase I clinical trials.

Laboratory Solutions

Laboratory Solutions streamline research processes, offering tailored tools and services to enhance efficiency and quality.
From sample analysis to data management, these solutions optimize workflows and drive innovation in drug development and clinical research.

Cell Sourcing

Cell sourcing is the crucial process of obtaining cells for research or therapy. Only a quality source can ensure suitability for various applications in biotechnology and medicine, and we pride ourselves on having some of the best.

Phase II+

The difficult part of drug development doesn’t end after Phase I, and in fact is just the beginning. Regulatory bodies have increasingly higher standards the closer to final marketing approval the investigational product is.
Furthermore, the cost of studies rises exponentially with each passing clinical phase, lowering the leeway for mistakes. A competent regulatory and scientific team is thus mission-critical to continued development and ultimate success.

IND Submission

Together, we can:
  • Eliminate regulatory pitfalls
  • Keep development on track
  • Ensure appropriate strategy at each step
  • Structured data management
Additionally, we also offer a full-service IND strategy, where our guidance spans the entire drug development process, ensuring a flexible and agile approach where solutions are tailored and streamlined to meet individual project needs.
For this, our solutions include:
  • Fact-based decisions to improve probability of success and regulatory approval
  • Risk analysis and mitigation, both regulatory and operational
  • Highly transparent workflow and communication

Contact us for more information.

Regulatory Strategy Consulting

  • Regulatory strategy consulting is essential for navigating the intricate regulatory landscape of the pharmaceutical and biotech industries. Expert consultants provide guidance on developing tailored strategies to expedite product approval processes, ensure compliance with regulations, and optimize market access.
  • From early-stage planning to post-market support, regulatory strategy consulting ensures companies meet regulatory requirements efficiently, enabling them to bring innovative therapies to market swiftly and effectively.

Asset Development

  • All but the largest biotech companies face considerable drug development challenges, as they often need to keep teams small and agile enough to maintain a competitive and innovative edge. Further, they are faced with resource constraints and will likely encounter a problem that cannot be addressed with in-house capabilities. Worse, they have a lack of trustworthy partners to confide in their intellectual properties (IP).
  • Through YC Biotech’s end-to-end solutions, we can simultaneously ameliorate all these concerns and ensure a smooth transition from preclinical to IND.

試驗設計

試驗計劃的複雜性和要求近年來不斷增加，使受試者和研究人員帶來了負擔，也可能影響受試者的參與率。然而，中途修改試驗計劃將增加開發計劃的時間和成本，並不能保證結果的改善。
您可以確保協議的高質量設計，從而提高研究的成功機會，同時降低時間和成本。

化學、製造和控制（CMC）

藥物開發的生命週期，其中包括多個關鍵階段，其中之一就是化學、製造和控制（CMC）。在臨床前藥物開發階段，需要驗證適當的分析方法，以監測產品並啟動穩定性測試。同時，需要確定產品的理化性質，原材料被選擇並進行測試。當藥物開發進入臨床階段時，則需要進一步驗證分析方法，以提供藥品額外的特性描述。
在臨床試驗結束後，放大生產過程必須確保大批量的產品與臨床試驗中測試的藥物相同，並符合相同的規格要求。並在製造過程經過品質確認後，將繼續進行過程中的檢測和批量放行。CMC並非一個靜態的過程，而是一個不斷演變，不斷監測品質的繁瑣過程。
透過我們的專業支持，客戶可以確保其藥物開發過程順利進行，並符合相關的法規和品質標準，從而實現成功的藥物上市。

藥效學 (PD)、藥物動力學 (PK) 和藥物動力學 (TK)

昱君生技了解非臨床藥效（PD）、藥物動力學（PK）和毒理動力學（TK）分析對於早期藥物開發的重要性。這些分析不僅在臨床一期試驗之前，而且在試驗後仍然具有關鍵意義。這些分析的正式性和符合GLP要求是證明藥物療效並確保持續成功的基石。同時，它們也是探索不同臨床方法（如給藥途徑）的基礎。

 

我們可以透過以下方式幫助簡化流程：
  • PK樣本分析
  • 快速PK篩選
  • ELISA 測試
  • 最佳給藥方案分析
透過我們的專業支援，客戶能夠有效地進行藥物開發流程，並確保最佳的臨床結果。

實驗室解決方案

昱君生技提供的實驗室解決方案，旨在簡化研究流程，並提高效率和品質。從樣本分析到數據管理，我們的客製化工具和服務能夠優化工作流程，推動藥物開發和臨床研究的創新。
我們致力於幫助客戶提升實驗室效率，優化流程，並加速新藥的開發和研究。

生物統計學

昱君生技作為專業的CRO公司，深知生物統計學的重要性。
我們不僅提供統計分析，更將我們對疾病和生物製品科學的理解，以及對寶貴的前期研究設計和全面規劃的協助知識融入其中。提供客戶最佳的資料分析和策略建議，以實現項目的成功。

臨床試驗的財務規劃與合約管理

在臨床一期階段，昱君生技會對臨床試驗研究計畫整體的經費需求進行評估和規劃，以確保財務支出合理且按時給付。我們制定明確的項目範圍、預算、時間表及具體的服務條款，擬定詳細的合作契約，確保合約符合相關法律、法規及監管單位的標準。

 

昱君生技致力於協助委託方減輕財務和管理上的負擔，從而提高臨床試驗的效率和質量。

以受試者為中心的服務

昱君生技深知目標群體的需求和關鍵決策的重要性。這種理解有助於從受試者的角度優化方案，進而提升可行性、招募和保留率。我們致力於提供全面支援，以幫助客戶實現這一目標。
我們將協助客戶實現高效、聚焦的策略，提高受試者在整個試驗過程中的參與，從而促進項目的成功進行。

支援臨床研究中心

以昱君生技的角度來看，臨床研究中心所需的支援項目遠超出表面所見。
首先，基礎設施的建置需要符合監管機構的嚴格要求，包括各種方面，從設備和資訊儲存、系統控制、盲化、數據透明度和共享。同樣重要的是確保數據的安全性，無論是在實體還是數位方面。技術能力、招聘流程、利益衝突和運營基礎設施的運作、維護也是不可或缺的。
此外，我們也必須關注其他方面，如安全報告、預防和糾正措施，以及受試者的招募、參與、福利等。整體的風險和效益的溝通、知情同意程序的透明度，以及 IRB 批准等。
因此，昱君生技的角色是確保臨床研究中心的各項支援項目都得到妥善處理，以利研究的順利進行和受試者的安全。

客製化解決方案

昱君（YC Biotech）以提供定制解決方案為信念，我們深信一切都應該是靈活且可定制的。
我們的產品始終可以根據當前需求快速進行定制。

監管支援

在產品生命週期的研發階段，提前制定法規計畫是一個強大的戰略工具。可以預先識別未來的關鍵挑戰，並作為與相關監管機構持續溝通和互動的指南。在這個複雜的環境中，可以確保研究產品符合法規和商業要求，是非常大的挑戰。

 

我們可協助客戶成功應對監管單位的挑戰，確保其產品順利通過監管審核，並實現商業模式。

生物分析

在藥物開發過程中，精確的生物分析至關重要。這不僅可以確保研究結果的準確性，也是監管機構認可的關鍵。
我們的專業團隊將致力於為您提供高質量的生物分析服務，以確保您的研究取得成功。透過我們的技術和經驗，您可以放心依賴我們，實現藥物開發過程中生物分析的準確性和可靠性。

篩選和分析

檢測方法是證明 IND 研究有效性不可或缺的一個面向，檢測方法的開發至關重要。
在篩選開始之前，研發客製化檢測項目或對既有的檢測進行評估，是防止被監管機構否決的關鍵保障。

藥理學和毒理學研究

在藥物開發的前期，評估藥物特性至關重要，並確保從發現階段順利進展到IND（Investigational New Drug）階段，因為毒性是導致藥物無法繼續進行臨床一期試驗的主要原因，故準確的評估有助於避免研究資源的浪費。
實驗室解決方案

昱君生技了解到實驗室解決方案對於優化研究流程至關重要，以提高效率和品質。
從樣品分析到數據管理，我們量身定制的工具和服務將有助於推動藥物開發和臨床研究的創新。
我們致力於幫助客戶實現更高效的實驗室運作，加速研究進程，並最終實現成功的藥物開發和臨床研究。

細胞來源

高品質細胞是研究和治療中不可或缺的一步。
我們擁有通過GMP認證的細胞來源，確保其在生物技術和醫學領域的廣泛應用。

法規與監管的戰略諮詢

  • 在新藥開發和生物科技領域，制定有效的策略至關重要。
企業需要全面了解法規與監管要求，另外尋求專家顧問的指導，以量身訂做相關的策略。昱君生技提供專業的指導，以幫助企業應對複雜的法規監管要求，確保合規性，加速產品批准與市場准入的流程。
我們的專家顧問團隊致力於確保客戶能夠順利達成以上目標，從而使創新療法更快地進入市場，從早期規劃到上市後的支持，我們的服務將為客戶提供全方位的支持。

送審IND（Investigational New Drug）

以下是我們的解決方案：
  • 釐清法規內容
  • 保持開發進度維持在正軌
  • 確保在每一步都採取適當的策略
  • 建立結構化的數據管理
此外，我們還提供完整的IND策略服務，我們的指導涵蓋整個藥物開發過程，確保提供靈活和敏捷的方法，客製化和簡化解決方案，以滿足各個專案項目需求。我們的解決方案包括：
  • 基於事實的決策，以提高成功機率和監管批准的可能性。
  • 監管和營運方面的風險分析和解決方案。
  • 高度透明的工作流程和溝通

如果您想瞭解更多信息，歡迎隨時聯繫我們。

臨床二期與後續

在藥物開發過程中，隨著進入 Phase II、III，研究產品逐漸接近最終上市批准，監管機構的標準也越來越高。每個臨床階段的進展都帶來指數級增長的研究成本，因此出錯的餘地被大幅降低。在這樣的環境下，一支專業的監管和科學團隊對於持續發展和最終成功至關重要。

 

昱君生技致力於提供全方位的支持，確保客戶能夠順利應對這些挑戰，實現順利上市和商業成功。

知識產權有效運用與規劃

  • 對於許多新創的生物科技公司而言，藥物開發的道路充滿了挑戰。他們需要在保持團隊的靈活和創新的同時，又需要面對資源上的許多限制。這樣的環境下，他們可能難以內部解決所有問題，也缺乏可信賴的合作夥伴來保護知識產權（IP）。
  • 昱君生技作為一家專業的CRO公司，致力於提供全方位一站式解決方案，協助生物科技公司克服種種挑戰。我們了解到，從臨床前研究到IND申請的每個階段都需要專業的支持和協助。因此，我們提供了全方位的服務，以確保客戶可以順利通過每個研發里程碑。
  • 透過我們的服務，生物科技公司可以專注在核心業務，放心地將藥物開發的其他方面交給昱君生技。我們不僅提供專業的技術支持，還確保客戶的知識產權得到充分保護。使生物科技公司可以在競爭激烈的市場中保持領先地位，實現創新並取得成功。