Paizhen Biotech announces that Asia's first cGMP-level AAV production base with a capacity of 4000L has been put into full production

On September 10, 2021, the world’s leading AAV gene therapy CDMO company- Guangzhou
PackGene Biotechnology Co.

, Ltd.

Guangzhou PackGene Biotechnology Co.

Solving the challenges faced by the gene therapy industry

Solving the challenges faced by the gene therapy industry

In 1972, the American biologist Theodore Friedmann and others first proposed the concept of gene therapy in Science.
After nearly half a century of development, the consensus in the field of gene therapy is: safety, Efficient genetic information delivery carrier is the key to gene therapy
.

Among them, adeno-associated virus (AAV) occupies a dominant position in gene therapy vectors due to its superior safety, long-term stability of expression, and extensiveness of targeted tissues

In 1972, the American biologist Theodore Friedmann and others first proposed the concept of gene therapy in Science.

Paizhen Biotechnology was established in 2014, focusing on the CDMO business of AAV gene therapy vectors.

Pai Zhen biological gene therapy vector cGMP-level production base (Pai Zhen Kun base)

Pai Zhen biological gene therapy vector cGMP-level production base (Pai Zhen Kun base)

The Pai Zhenkun base is located in Huangpu District, Guangzhou, China.
The production base also complies with the cGMP requirements of China's NMPA, US FDA, EU EMA, and Japan MHLW.
It is equipped with a world-leading large-scale gene therapy production platform with a production capacity of 4000L , which will satisfy global partners From innovative concepts to IND declarations, clinical sample production, and commercial production of gene therapy drug development needs
.

Pai Zhenkun Base This production base also meets the cGMP requirements of China's NMPA, US FDA, EU EMA, and Japan MHLW, with a production capacity of 4000L

The design of Paizhenkun base adopts the one-time process design concept, and the liquid preparation , storage, cell culture, fermentation, purification, etc.
that are in direct contact with the product are all disposable, to avoid cross-contamination between different varieties and batches to the greatest extent
.

The design of Paizhenkun base adopts a one-time process design concept,

The Pai Zhenkun base has the world's leading adherent cell production system with an attachment area
of up to 500m2, a top-notch suspension cell production system with a volume of up to 500L, a variety of advanced purification systems, and an automatic isolator filling system .

The Paizhenkun base has multiple production process routes and has achieved GMP large-scale production.

An adherent cell production system with an attachment area of ​​up to 500m2 and a top-notch suspension cell production system with a volume of up to 500L, a variety of advanced purification systems, and an automatic isolator filling system

The production base has complete hardware facilities and quality management system

The Paizhenkun base adopts leading "Single-use Technology" (Single-use Technology) in accordance with the requirements of cGMP construction specifications
.

Compared with traditional reactors, the advantages of "one-time use" consumables are mainly reflected in efficiency, cost and quality

The Paizhenkun base adopts leading "Single-use Technology" (Single-use Technology) in accordance with the requirements of cGMP construction specifications

Kun base camp really in accordance with the concept of quality by design (QbD) of, AAV vector plasmid production workshop production workshop and are provided in two separate buildings, Du effective way out of cross-contamination in the past shared platform CDMO type commonly used in industry exist Hidden dangers

Focus on the present and look forward to the future

With the full-scale production of the Paizhenkun base with an area of ​​8,000 square meters, Paizhen Biologics cGMP-level AAV production capacity will be greatly improved, which also marks that Paizhen Biologics, as the pioneer of domestic gene therapy CDMO, will take the lead in large-scale production capacity.
, Greatly reduce production costs, accelerate the advancement of innovative pharmaceutical companies and the transformation of high-quality results, and empower the leap of the gene therapy industry!

Paizhen Biotech has always adhered to the development mission of "making gene therapy affordable for the common people", committed to solving industry bottlenecks and promoting the rapid development of the entire industry
.

Patricon Biosciences is making continuous strides towards becoming a leading supplier of gene therapy AAV vectors , in the hope that in the future it can help more gene therapy companies to better develop gene therapy drugs that benefit ordinary patients, and bring hope to patients around the world Light

Paizhen Biotech is committed to solving industry bottlenecks and promoting the rapid development of the entire industry
.
Leading gene therapy AAV vector supplier

About Paizhen Biotech

About Paizhen Biotech

Paizhen Biotechnology has long focused on rAAV gene therapy CDMO, rAAV virus packaging, lentivirus packaging, vector cloning services, providing economic, efficient, large-scale, and compliance control for basic research, preclinical development and clinical trials of gene and cell therapy Viral vector solutions
.
Paizhen Biotech has a high-level viral vector development and large-scale production platform, and has core intellectual property rights in the rapid, high-purity, high-titer, and high-infectious rAAV production and virus packaging.
It has core intellectual property rights in vector construction, virus packaging, and clinical-grade plasmids.
He has accumulated rich experience in the production of AAV and is familiar with the regulatory requirements for gene therapy products such as FDA, ICH and NMPA
.
In recent years, Paizhen Biotech has established long-term cooperative relationships with many internationally renowned pharmaceutical companies, Harvard Medical School, Chinese Academy of Sciences, Tsinghua University, Peking University, Sun Yat-sen University and other units, and established a comprehensive strategic partnership with Danaher Pall
.