Services

Performance Study

  • New Bone regeneration study
  • Example as below:
  • CT graphic example as below:
  • Hemostatic device
  • Wound healing
    Epidermal tissue histopathology photo
  • Degradation study
  • Cell-therapy tumor perfromance study
    IVIS of Lung cancer cell

IVIS of Lung cancer cell

IVIS of Lung cancer cell

Pharmaceutical/Chemical toxicity study

Leon Biotech Preclinical Safety Toxicology Service addresses the requirements of drug product research and development, and conducts preclinical safety assessment tests according to the regulations of health authorities before clinical trials to prove the safety and toxicology of products. Leon Biotech conducts pharmacological safety toxicology tests according to FDA, OECD and other specifications. With TAF OECD GLP, ISO 17025 certified quality system practices, it provides reliable and stable professional services and planning consulting.

  • Pharmacokinetic/pharmacodynamic modeling*
  • Absorption, distribution, metabolism/catabolism, and elimination (ADME) *
  • Genotoxicity Study
    • OECD 473-In Vitro Mammalian Chromosomal Aberration Test(Alternative with OECD490)
    • OECD 490-In Vitro Mammalian Chromosomal Aberration Test/ Cell Gene Mutation Tests Using the Thymidine Kinase Gene(Alternative with OECD473)
    • OECD 474-Mammalian Erythrocyte Micronucleus Test
  • Toxicology study
    • Acute/LD50 toxicological study
    • Sub-acute repeat dose toxicity study (Oral, Dermal, IV, IP)
    • Sub-Chronic repeat dose toxicity study (Oral, Dermal, IV, IP)
  • Histopathological study service

<Chemical Registration Safety Toxicology Service>
According to the chemical standard registration operation specifications announced by the Chemical Bureau of the Environmental Protection Agency, Leon Biotech provides standard registration toxicology testing services as follows:

Recommend testing method

Standard registration

1234
【OECD TG 420】Acute Oral toxicity-Single dose
【OECD TG 423】Acute Oral toxicity - Acute Toxic Class Method.
【OECD TG 402】Acute Dermal toxicity
【OECD TG 404】Acute Dermal Irriation/ Corrosion
【OECD TG 405】Acute Ocular Irritation/ Corrosion
【OECD TG 406】Skin Sensitization
【OECD TG 429】Skin Sensitisation
【OECD TG 471】Bacterial Reverse Mutation Test
【OECD TG 473】In Vitro Mammalian Chromosomal Aberration Test
【OECD TG 474】Mammalian Erythrocyte Micronucleus Test
【OECD TG 417】Toxicokinetics Book ( Proposal Acceptable)
【OECD TG 408】Repeated Dose 28-Day Oral Toxicity Study in Rodents
【OECD TG 408】Repeated Dose 90-Day Oral Toxicity Study in Rodents
【OECD TG 414】Prenatal Developmental Toxicity Study
【OECD TG 416】 Two-Generation Reproduction Toxicity ( Proposal Acceptable)
【OECD TG 451】Carcinogenicity Study ( Proposal Acceptable)

Health food toxicity study

Definition of Classification

Genotoxicity ( 3 items)

Repeated Dose 28-Day Oral Toxicity Study in Rodents

Repeated Dose 90-day Oral Toxicity Study in Rodents

Prenatal Developmental Toxicity Study

Carcinogenicity Study

Reproduction Study

Category 1

Products made from traditional food ingredients and manufactured with normal processing techniques or methods

X

X

X

X

X

X

Category 2

Products made from traditional food ingredients but manufactured with non-traditional processing techniques or methods

X

X

X

X

Category 3

Products made from non-traditional food ingredients

X

X

X

Category 4

Products made from non-traditional food ingredients and may have carcinogenic ingredients

X

Toxicity/Safety study method

OECD 471-Bacterial Reverse Mutation Test
OECD 473-In Vitro Mammalian Chromosomal Aberration Test (Alternative with OECD 490)
OECD 490-In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene (Alternative with OECD 473)
OECD 474-Mammalian Erythrocyte Micronucleus Test
OECD 407-Repeated Dose 28-Day Oral Toxicity Study in Rodents
OECD 408-Repeated Dose 90-day Oral Toxicity Study in Rodents
OECD 414-Prenatal Developmental Toxicity Study
OECD ***-Carcinogenicity Study
OECD ***-Reproduction Study

Medical Device Extractable/Leachable study

According to the ISO 10993-1 standard, medical devices must first comply with ISO 10993-18 to evaluate the chemical characteristics of medical devices. The Extractables/Leachables evaluation occupies important steps in device product development process including process equipment, primary and secondary packaging; Monomer and polymer additives and other harmful substances during the process may migrate into the product under storage conditions. Leon Biotech have rich experience and provides complete test planning consulting services for extractable in products and packaging materials and leachables in final products.

Services

  • Complete consulting solution for analytical testing
  • Extractables & Leachables Customized analytic services
  • Extractable composition analysis (including organic and inorganic)
  • Qualitative and quantitative study of extractables
  • Method development and validation of analytical methods for finished product leachables
  • Chemical test (dissolution test: heavy metals, pH, Non-Volatile Residue (NVR), FTIR)
  • National Pharmacopoeia General Test Plan

無菌試驗簡介

目的
為確實評估規定為無菌之醫療器材產品,在經過滅菌後的滅菌完整性及有效性,故參照美
國藥典USP-30<71>以及ISO 11737之相關規定。

範圍
本試驗方法適用於醫療器材產品經滅菌後之無菌測試;本方法及其結果主要目的為輔助產
品之滅菌確效及增加例行滅菌批次品質保證信心程度,不建議單獨使用於例行滅菌批次放
行,且不用以確保批次中各產品為無菌或滅菌完全放行之依據。

無菌檢查
無菌檢查法包括微孔濾膜過濾法和直接接種法。進行檢品無菌檢查時,所採用的檢查方法
和檢驗條件應與驗證的方法相同。

結果判定一
於培養期間及終了時,定期觀察檢視所有樣品與對照組之微生物生長情形,並依下列原則
判定之:
(a) 對照組:陰性對照組:應呈現無微生物生長之陰性反應。陽性對照組:應呈現有微生
物生長之陽性反應。以上兩種對照組均須依預定之反應呈現結果,否則該批測試結果視為
無效。
(b) 樣品組:陰性反應:表該樣品滅菌完全,無微生物存活。陽性反應:表該樣品滅菌不
完全,有微生物存活。

結果判定二
當樣品呈陽性反應有微生物生長時,若符合下述其一條件者,則表示所生長的微生物非檢
品所含,判定測試結果無效:
(a) 無菌檢測時所使用的設備及環境微生物監測結果不符合無菌檢查之要求;
(b) 檢討試驗流程中,有引起微生物汙染的可能因素;
(c) 陰性對照組有微生物生長;
(d) 樣品組中生長的微生物,經確認是由無菌試驗過程中所使用的物品,或是無菌操作技
術不當所引起的。

Cleaning/ Disinfection process validation

“Reusable medical device ” is reprocessing procedures that follow specific instruction procedures, including cleaning, disinfection, and sterilization procedures. Device manufacturers need to specify reprocessing procedures in the Instruction for use manual and submit a validation report to the review agency.

Leon Biotech Co., Ltd has many experience of planning the “Reusable Medical Device ” reproressing validation plan and submit US FDA/ EU notified body review and accepted, and follow the US FDA guidelines,we can provide planning and implementation of reusable use product validation study.

  • “Reused Medical Device Products” Validation Plan Planning Consultation
  • Test Soil design for clinical specific situations
  • Planning of validation verification scheme for repeated use of initial sterile products
  • Planning of validation verification scheme for repeated use of non-sterile products
  • Planning of validation verification scheme for repeated use of home medical equipment
  • Reuse validation program execution and report writing

服務內容

 

1. ISO 10993及中國GB/T 16886 生物相容性試驗方案規劃

ISO 10993-1 生物相容性試驗風險評估/項目規劃
ISO 10993-3 基因毒性試驗(沙門氏菌回復突變試驗/體外哺乳動物細胞基因突變試驗/體外哺乳類染色體結構畸變試驗/囓齒類週邊血液微核試驗)
ISO 10993-4  血液相容性試驗(溶血試驗/血栓試驗/補體啟動試驗/血小板黏附試驗/凝血試驗)
ISO 10993-5 體外細胞毒性試驗
ISO 10993-6 肌肉植入試驗
ISO 10993-6 皮下植入試驗
ISO 10993-6 骨植入試驗
ISO 10993-10 大白兔皮膚/皮內刺激性試驗
ISO 10993-10 天竺鼠皮膚致敏性試驗
ISO 10993-11 急性全身毒性試驗/亞急性全身毒性試驗/亞慢性全身毒性試驗/慢性全身毒性試驗
ISO 10993-11 大白兔熱原試驗
ISO 10993-17 & ISO 10993-18 材料化學特性分析與毒理風險評估
萃取Extractable/溶出 Leachable 試驗評估
ICP/MS、LC/MS、GC/MS、FTIR等分析方法開發
毒理風險評估計算(NOAEL、LOAEL & MOS)

2. 醫療器械大動物功效性試驗(比格犬、迷你豬、羊、猴子)

3. 重複用醫療器械清潔確效及消毒驗證

4. ISO 18562 呼吸器產品測試方案規劃

生物相容性測試項目

・體外細胞毒性試驗
・致敏試驗
・皮膚刺激試驗
・皮內刺激試驗
・急性全身毒性試驗
・亞急性全身毒性試驗
・亞慢性全身毒性試驗
・慢性全身毒性試驗
・熱原試驗
・染色體畸變試驗
・骨髓微核試驗

・凝血試驗
・血小板粘附試驗
・補體激活試驗
・溶血試驗
・肌肉植入試驗
・皮下植入試驗
・骨植入試驗
・鼠傷寒沙門氏菌
・恢復突變試驗
・基因突變試驗
・血栓形成試驗

Sterilization Validation

The sterilization process is a key part of the aseptic product. LEON Biotech has many years of experience in assisting customers with complete sterilization planning, and is constantly updating the latest global regulatory services and meeting the technical requirements of the review authority, including EO sterilization foundry. With the effective planning, the moist heat sterilization confirmed the ISO 17665, and the sterilization parameters of the reusable device products were confirmed.

  • ISO 11137 (Gamma Radiation)
  • ISO 11135 (EO sterlization )
    • Sterilization process design and consulting
    • Bioburden/BIs validation method
    • Overkill method
    • ISO 10993-7 (EO、ECH residue analysis)
  • Moisture steam sterilization validation
    • ISO 17665 non Sterile device sterilization validation
    • Reusable device sterilization validation (AAMI ST79)

服務內容

  1. 中國 醫療器械質量管理體系諮詢輔導
  2. 美國 QSR/ISO 13485系統輔導諮詢
  3. 歐盟 MDD-MDR 系統轉版輔導
  4. 台灣 GMP 系統輔導

Medical device Package test

The package of medical device plays an important role in maintaining sterile environment and protecting property for sterile medical device. Leon Biotech follow international standards ISO 11607 and EN868, ASTM regulations to provide well-established and validated testing services for medical device package and shipping package, we are based on the following specifications:

Testing target

Test item

Method

Aging study

constant temperature and moisture test storageASTM F1980

Package material

Burst test ASTM F1140
Creep test
Dye penetrationASTM F1929
Microbial barrier test ASTM F1608
Microbial barrier test DIM 58953-6

Intrinsic matter

Sterility test ISO 11737-2

Package material

Seal peel test ASTM F88

服務內容

 

中國

  1. 國產 /進口醫療器械 中國註冊服務
  2. 中國 醫療器械動物試驗設計及臨床 豁免評估
  3. NMPA 中國醫療器械產品注册及可用性評估
    產品技術要求撰寫
    產品註冊檢驗追蹤
    產品註冊申報資料編寫
    註冊補充資料技術指導
    專家審評會組織協調
  4. NMPA 中國醫療器械臨床試驗
    臨床試驗方案及總結報告撰寫
    臨床試驗項目管理
    臨床試驗監察
    臨床試驗數據管理
    臨床試驗統計分析
    稽查及培訓
    臨床試驗數據採集分析系統
    臨床評價報告(CERCER)撰寫

OECD GLP CERTIFIED BIOCOMPATIBILITY TESTING SERVICE

ISO10993、生物相容、FDA、毒理,動物實驗,醫療器材,健康食品,化學品

LEON Biotech has an international OECD GLP certified laboratory. Generally, the safety and effectiveness of medical devices is the major goal of product certification. Medical devices that directly or indirectly contact with the human body have to complaince with global ISO 10993 series international standard for safety risk assessment to ensure that the products passed pre-market approval. Into the request. With our experienced veterinarians and technical expertise in the companies, Leon Biotech already assist thousands of companies passed US FDA and Notified Body CE techinical review.Our testing report also widely acceptable by worldwide government authoriy for product submission.

Category

In vivo test / In vitro test

Test item

Method

Cytotoxicity

In vitro test

CytotoxicityISO10993-5

Irritaiton

In vivo test

Skin irriation ISO10993-10
Intracutaneous irritation
Oral mucosa irriation
Ocular irritation
Rectal irritation test
Penile irritation test/Vaginal mucosa irritation test

Skin Sensitization

In vivo test

Skin Sensitization

Acute systemic toxicity

In vivo test

Acute systemic toxicity ISO10993-11
Pyrogenic test USP151

Subacute systemic toxicity

In vivo test

14-28 days repeat dose systemic toxicity -Extraction methodISO10993-11
14-28 days repeat dose systemic toxicity -implantation method

Sub chronic systemic toxicity

In vivo test

28-90 days repeat dose systemic toxicity -Extraction method
28-90 days repeat dose systemic toxicity -Implantation method

Chronic systemic toxicity

In vivo test

180-365 days repeat dose systemic toxicity -Extraction method
180-365 days repeat dose systemic toxicity -Implantation method

Subchronic system toxicity (New)

In vivo test

14 days repeat dose systemic toxicity -extraction method

Genotoxicity

In vitro test

Bacterial Reverse Mutation Test OECD471
In Vitro Mammalian Chromosomal Aberration Test/ Cell Gene Mutation Tests Using the Thymidine Kinase OECD473

In vivo test

Mammalian Erythrocyte Micronucleus Test OECD474

Implanation

In vivo test

4-24 weeks Subcutaneous tissue/Muscle/BoneISO10993-6

Hemacompatilbity

In vivo test

in vivo ThrombogenicityISO10993-4

In vitro test

in vitro Hemolysis test(direct and indirect contact)ISO10993-4

In vitro test

Platelets / white blood cells analysisISO10993-4

In vitro test

Partial Thromboplastin Time (PTT)ISO10993-4

In vitro test

Complement Activation, SC5b-9 & C3aISO10993-4

ISO 10993-1:2018 the latest version of medical device biocompatiblity evaluation chart

X= Mandatory , E= Endpoint of final device evaluation , F= USFDA guidance request additional items

服務內容

 

美國

FDA 510(k)申請 (MD&IVD)
PMA申請
De Novo申請
FDA Pre-submission Service (FDA預審查申請及諮詢服務)
FDA Listing (註冊列名)

 

歐盟

1、歐盟醫療器械 CE 法規服務
2、CE 技術檔案建立與諮詢顧問
3、品質系統 ISO 13485 法規輔導諮詢
4、臨床評估報告 Clinical Evaluation Report/上市後監控(PMCF)與上市後追蹤諮詢(PMS)
5、歐體代表(Euro Rep)登錄服務
6、歐盟 Notified body 2195 SZUTEST
7、符合 MDR CE Mark/符合MDD CE Mark-2020/05月

 

台、韓、印、新

1.台灣TFDA I/II/III類醫材註冊
2.韓國KFDA/印度/新加坡國際註冊