CRO Services-Beijing Cygenta Biotech Co., Ltd.

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Service Platform CRO Services

We can provide customers with plasmid, virus, cell and quality control services in the whole life cycle of early development-IIT-IND-clinical-commercialization, accelerate product development process and solve unmet clinical needs.

Process Development and Optimization

We have years of experience in process development and optimization for CGT products such as plasmids, lentiviruses, AAVs, and CAR-T cells.

service features：

10 + years experience in CGT product process development

Advanced QbD development concept

Extensive experience in project transform from the laboratory to the clinical stage

Successfully supported of IND and NDA of multiple CGT products

Process Development

Cell line screening and domestication development
Cultivation process development
Purification process development
Formulation process development

Analytical Method Development, Validation/Verification

10 + years of experience in the development and validation of analytical methods for biological products

Familiar with Chinese, USA and European Pharmacopoeia, ICH Q2/Q14 and other relevant regulatory requirements

Based on the concept of Quality by Design (QbD), provide analysis method development and validation services for the whole product life cycle

Successfully supported multiple CGT product registration declarations

Services include: CGT-related product analysis method development services; CGT-related product analysis method validation services

QbD

Filling Services

GMP
Production

Supports clinical and commercial grade plasmids, lentiviruses, adeno-associated viruses and other products. Support a variety of packaging materials, such as vials, COP bottles, etc. The filling volume covers the range of 0.25 ml to 10 ml, and the minimum filling volume is 500 ml.

High standards of cleanroom environment levels; stringent contamination control strategies; highly automated process design; comprehensive data management; rigorous quality management system.

Quality Control Services

Assist in the development or optimization of quality standards, including bacteria strain, cell bank, virus seed, plasmid vector, virus vector, CAR-T, AAV products, etc.
Process control and final product release testing
Provide a one-stop service for the formulation, implementation and reporting of stability research programs
Provide external individual testing services, such as safety-related RCL, rCAAV, sterility testing, mycoplasma, endotoxin testing, etc.

Registra
tion

Registration Consultation & Registration Filing

Registration Consultation

Product Development Strategy

Case assessment & analysis

Identification and Resolution of Phase-Specific Challenges Throughout the Project Lifecycle

Explore the development of optimal registration pathway

Quick pre-review and feasibility assessment before filing

Preparation and organization of various CDE communication meetings

Effectively guide and respond to questions raised by regulatory authorities

Registration Filing

Compilation and submission of documents for IND/NDA/supplementary applications

Application for registration of the whole project management

Coordinate drug registration testing

Assist in on-site inspection

Follow up the progress of review and administrative approval

Registration Advantage

20 + years of biological product registration experience, supporting 12 + CGT products approved IND and NDA
Expertise in the registration regulations and technical requirements of both China and the U.S., with a commitment to continuously monitoring and promptly adapting to the latest policy and regulatory changes
Maintain good communication with regulatory authorities to help customers develop/adjust product registration strategy
Be familiar with the requirements of product registration review and approval, and track the whole process of product registration

GMP Consulting

01
GMP quality management system strategy consulting
02
GMP compliance on-site audit and improvement guidance
03
GMP compliance difficult problem handling
04
GMP plant construction drawings review and compliance recommendations
05
Effective guidance to remediate the GMP noncomformities proposed by the inspectors
06
Consultation on Application for Drug Production License

Advantages of GMP Consulting

The team has more than 20 + years of experience in the operation of commercial GMP quality system for biological products, and has received 30 + compliance inspections from domestic and foreign authorities.

In-depth understanding of GMP regulations and guidelines in China and USA, grasp the latest developments of policies and regulations at the first time.

Maintain good communication with government inspectors to help customers build and improve quality management systems.

Confirma
tion Qualification/Validation of Premise Facilities and Equipment

CYGENTA Services Platform is committed to providing customers with a full range of biotechnology services, including qualification/validation of premise facilities and equipment. In order to ensure the quality and reliability of the platform service, CYGENTA will carry out facility equipment qualification/validation according to the requirements of different R&D stages and customer needs.

Clean Laundry Services

Washing and disinfection of cleanroom garments is an essential safeguard for personnel contamination control in cleanrooms. The cost of building a GMP-compliant cleanroom garment washing factory is exorbitant. We provide cleaning and disinfection services for cleanroom garments at different cleanliness levels for users, in accordance with the ISO 9001: 2000 standard, the Good Manufacturing Practice (GMP) for Pharmaceutical Production, the Good Manufacturing Practice for Medical Devices, and the Sterile Medical Device Production Management Standard.