First Public Disclosure of the Environmental Impact Assessment for the R&D and Production Building Construction Project (Third Floor) of Beijing Minhai Biotechnology Co., Ltd.

Release date:

2019-04-26

Author:

Source:


Abstract

(1) Project Name: Construction Project for the 13‑Valent Pneumococcal Conjugate Vaccine Workshop and the Acellular Pertussis (Component) Vaccine Bulk‑Drug Substance Workshop of Beijing Minhai Biotechnology Co., Ltd. (2) Site Location: The reserved workshop on the third floor of the R&D and Production Building at the Beijing Minhai Biotechnology Co., Ltd. within the Daxing Biopharmaceutical Industry Base of the Zhongguancun Science Park, Daxing District, Beijing.

(1) Project Name: R&D and Production Building Construction Project (Third Floor) of Beijing Minhai Biotechnology Co., Ltd.

(II) Site Selection: The third-floor workshop space reserved within the R&D and Production Building of Beijing Minhai Biotechnology Co., Ltd., located at the Daxing Biopharmaceutical Industry Base in the Zhongguancun Science Park, Daxing District, Beijing.

The overview of the existing facilities and the environmental protection measures at Beijing Minhai Biotechnology Co., Ltd. are presented in the table below.

Overview of the Existing Project and Summary of Environmental Compliance Procedures

Serial number

Project Name

Main Construction Contents

Approval Reference Number

Approval Category

Environmental Acceptance upon Completion

1

Daxing Production Base Project of Beijing Minhai Biotechnology Co., Ltd.

Total land area: 80,889.6 m² 2 , including an office and R&D building, a production facility for the acellular diphtheria–tetanus–pertussis–Haemophilus influenzae type b combination vaccine, a production facility for the measles–mumps–rubella–varicella vaccine, an animal facility, a hazardous materials storage warehouse, a cafeteria, and a centralized wastewater treatment station, among others.

Beijing Environmental Review [2007] No. 777

Report

It passed acceptance inspection in December 2011, with approval document number Jing Huan Yan [2011] No. 284.

2

Minhai Biotechnology’s “Human Diploid Cell Rabies Vaccine” Industrialization Project

Lyophilized powder for injection of human diploid cell rabies vaccine, with an annual production capacity of 5 million doses (sufficient for 1 million people).

Jingxing Huan Shen [2012] No. 0212

Report

It passed acceptance inspection in March 2016, with approval document number Jingxing Huanyan [2016] No. 36.

3

23-valent Pneumococcal Polysaccharide Vaccine Industrialization Project

Annual production capacity of 10 million doses of the 23-valent pneumococcal polysaccharide vaccine.

Jingxing Huan Shen [2012] No. 0171

Report

It passed acceptance inspection in May 2016, with approval document number Jingxing Huanyan [2016] No. 78.

4

Construction of a Pilot-Scale Technology Platform for Biological Vaccines

Annual production capacity includes 100,000 doses (for 100,000 people) of a three-component pertussis vaccine, 400,000 doses (for 100,000 people) of a 15-valent pneumococcal conjugate vaccine, 300,000 doses (for 100,000 people) of an ACYW135 meningococcal conjugate vaccine, 100,000 doses (for 100,000 people) of a pentavalent rotavirus vaccine, and 500,000 vials per year (for 100,000 people) of a lyophilized human diploid cell–derived rabies vaccine.

Jingxing Environmental Review No. [2012] 0251

Report

Cancel construction

5

Pre-Filled Vaccine Workshop Construction Project

Annual production capacity of 36 million pre-filled vaccine doses.

Jingxing Huan Shen [2013] No. 2

Report Form

It passed acceptance inspection in March 2016, with approval document number Jingxing Huanyan [2016] No. 32.

6

Innovation Capacity Building Project for the Beijing Municipal Engineering Laboratory on Novel Vaccines

An engineering laboratory equipped with four platforms: a protein‑conjugate vaccine platform, a multivalent and polyvalent vaccine platform, an oral vaccine platform, and a vaccine quality‑evaluation platform.

Jingxing Huan Shen [2012] No. 0288

Report Form

Currently commissioning the final environmental protection acceptance inspection.

7

Pre-Fill Filling Workshop Construction Project

36-million-unit-per-year pre-filled syringe filling workshop

Jingxing Environmental Review

[2014] No. 220

Report Form

The environmental impact assessment for the address change has been approved. Jingxing Environmental Review [2019] No. 17

8

Beijing Minhai Biotechnology Co., Ltd. R&D and Production Building Construction Project

It includes a sub-packaging workshop, a finished-product cold storage facility, and a purified water station. The production facilities comprise one lyophilized rabies vaccine line with an annual capacity of 15 million doses and one liquid sIPV vaccine line with an annual capacity of 20 million doses.

Beijing Environmental Review

[2016] No. 203

Report

The acceptance criteria have not yet been met.

9

Minhai Biotechnology’s International Vaccine Industrial Base (Phase I) Construction Project

Total land area: 90,013.218 m² 2 , including a new production workshop, an R&D building, a sub‑packaging and storage building, an animal facility, a wastewater treatment plant, and associated ancillary facilities such as a hazardous waste and dangerous goods warehouse, a canteen, and a comprehensive service building, with a total floor area of 149,320 m². 2 Annual production capacity includes 25 million doses of pneumococcal conjugate vaccine; 20 million doses of an adsorbed acellular DPT–inactivated poliovirus–Haemophilus influenzae type b pentavalent vaccine; and the measles‑mumps‑rubella‑varicella vaccine series: 20 million doses of the measles‑mumps‑rubella combined live attenuated vaccine, 5 million doses of the measles‑mumps‑rubella‑varicella combined live attenuated vaccine, and 10 million doses of the lyophilized varicella live attenuated vaccine.

Beijing Environmental Review

[2019] No. 53

Report

/

 

(4) Name of the Project Owner: Beijing Minhai Biotechnology Co., Ltd.

Contact: Xia Zhanxiong

Contact number: 010-59613634

Email: xiazhanxiong@biominhai.com

(5) Environmental Impact Assessment Report Preparation Unit: Beijing Zhonghuan Bohong Environmental Resources Technology Co., Ltd.

(6) Online link to the public opinion form: http://www.biominhai.com/xwzx_xi/newsId=363.html

(7) Methods and channels for submitting public comments.

Phone: 010-59613634

Email: xiazhanxiong@biominhai.com

During the preparation of the draft environmental impact assessment report, the public may submit comments related to the environmental impact assessment to the project proponent.

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