1. 법률사항

법률사항

Expanded Access Policy

개인정보처리방침

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이메일무단수집거부

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Expanded Access Policy Introduction

  • 1. An investigational product should be used as part of a clinical trial. However, if patient enrollment is not possible for reasons, such as patient ineligibility, lack of ongoing clinical trials or if enrollment in a clinical trial is not feasible (e.g. distance to a trial precludes access), expanded access offers a possible route for gaining access to an investigational product, subject to FDA’s review.
  • 2. The best way for patients to be treated with Investigational Products is through participation in a clinical trial, please visit www.clinicaltrials.gov for more information about the trial and trial sites.
  • Helixmith Expanded Access Policy

    Helixmith focuses on discovering and developing novel gene therapy products. The following is Helixmith’s global expanded access policy for investigational therapies that are intended to treat serious diseases:

  • 1. Contact Information. At this time, Helixmith does not have any investigational gene therapy product candidates available for expanded access. If you have questions about our investigational product candidates or expanded access, please submit them to clinicaltrials@helixmith.com.
  • 2. Request Procedures. Helixmith is not currently making its investigational gene therapy product candidates available on an expanded access basis anywhere in the world. Requests for expanded access to Helixmith’s investigational gene therapy product candidates must come from the patient’s treating physician because only physicians can enroll patients in a clinical trial or expanded access program (EAP).

    General Criteria. Helixmith is not currently making its investigational gene therapy product candidates available on an expanded access basis anywhere in the world. In the event Helixmith Spark Therapeutics decides to consider making one or more of its investigational gene therapy product candidates available through an EAP, Helixmith will evaluate and respond to each expanded access request that it receives on a case-by-case basis using criteria that ensures such requests are considered in a fair and consistent manner.
  • 3. Anticipated Timing. Helixmith anticipates that it will acknowledge receipt of any expanded access questions or requests within seven (7) business days of receipt.
  • 4. Clinicaltrials.gov. As stated above, Helixmith is not currently making its investigational gene therapy product candidates available for expanded access use anywhere in the world. In the event that Helximith decides to make its investigational product candidates available on an expanded access basis, this policy will be updated with a hyperlink to the expanded access record on clinicaltrials.gov after such record becomes active.

    The posting of this policy by Helixmith shall not serve as a guarantee of access to any specific investigational drug by any individual patient. As authorized by and in accordance with the 21st Century Cures Act, Heixmith may revise this posted expanded access policy at any time without prior notice.
CGT Plant바이러스 벡터 및 세포치료제 제조구역
CGT PlantQC (품질분석) 구역

01.Cell Processing System

세포의 세척, 분리, 회수의 공정을 담당하는 장비
Leukapheresis product에서 PBMC를
분리하기 위해 사용함

02.T-Cell Isolator

PBMC에서 T-cell만 선택적으로 분리, 회수하는
장비

03.Wave BioReactor

세포 배양 장비

04.Cell Counter

Reactor에서 배양중인 배양액의 세포의 수를
측정하기 위한 장비 IPC 시 사용

01.BSC (생물안전작업대)

작업자의 안전과 무균작업 환경 유지 장비

02.CO₂ Incubator

정해진 CO₂ 농도와 온도 조건으로 바이러스
벡터를 배양하는 장비

03.CRF (Control Rate Freeze)

최종 포장 시 세포생존율 저하 방지하기 위해
일정 속도로 동결하는 장비

04.LN2 Tank

액체 질소를 이용 초저온 조건에서 보관가능한
장비세포 보관용으로 사용

01.Microplate Reader

물질의 광학적 성질을 이용하여 검체의 측정
물질의 양을 측정. ELISA 시험에 사용

02.Real-time PCR

마이코플라즈마 부정시험(신속법), 복제가능
바이러스시험법(신속법)에 사용

03.FACS

세포 입자의 물리적, 화학적 특성을 동시에 분석
세포의 특성확인시험, 순도시험 등에 사용

04.TOC Analyzer

총 유기탄소량 측정 장비 주사용수, 청정증기 등
제조용수의 유기물 정량 분석

01.BSC (생물안전작업대)

작업자의 안전과 무균작업 환경 유지 장비

02.배양기

약전 등에 정해진 온도로 배양하는 장비.
무균시험, 미생물한도시험, EM에서 배지
배양용으로 사용

03.클린벤치

외부오염 물질의 유입을 차단, 청정도 유지하는
장비. 무균시험, 미생물한도시험 등에 사용

04.Cell Counter

세포 내 단백질과 핵을 염색시켜 세포수를
측정하는 기기. 총세포수, 세포생존율 시험 시 사용