PRESS RELEASE FROM MILLIPORESIGMA

Restoration of Full Operations at MilliporeSigma’s Shanghai Biodevelopment Center

Posted Apr 27, 2020

Key measures used to safeguard employees and customers during the COVID-19 crisis

MilliporeSigma’s Biodevelopment Center in Shanghai, China provides cell line and process development and non-GMP clinical production at a scale of 200L for customers around the world. The Center is planning an expansion of the 3780m2 (~41k SQFT) facility in 2020 to include GMP clinical production up to 2000L. The Shanghai facility is part of a global network of MilliporeSigma Biodevelopment Centers. Other Centers are located in Martillac, France and Boston, Massachusetts.  The Centers offer contract development and manufacturing services through MilliporeSigma’s BioReliance® End-to-End Solutions, delivered by a team with more than 30 years of experience in process development with more than 250 biologics.

In response to the recent COVID-19 outbreak, MilliporeSigma took proactive steps to protect the Center’s employees and customers and ensure projects continuity. Tina Tao, Director, APAC Delivery, BioReliance® End-to-End Solutions at MilliporeSigma discusses the response and the precautions that have been established to ensure safety going forward.

 

Q:  Is MilliporeSigma’s Shanghai Biodevelopment Center fully operational?

A:  Yes, our Shanghai location is fully operational, and we are taking on new projects from customers around the world who need to outsource their therapeutic drug development. To ensure project continuity, we are closely and carefully monitoring global supply chains, and maximally use MilliporeSigma products to secure stable supply. For example, if a customer comes to us with a cell line development project, we can leverage our in-house CHOZN® cell line and immediately initiate the project. In this situation, our supply chain is independent from other suppliers.

 

Q:  What approach did you take to enable the Biodevelopment Center to remain open throughout this time?

A: At the Biodevelopment Center, we believe transparency and close communication are essential for successful customer engagement. From the earliest days of pandemic, we anticipated potential impacts to ongoing projects and proactively communicated this information to customers via virtual meetings. We also maintained the usual frequency of meetings and ensured timely communication via email.

We maintained essential activities related to cell culture and our bioreactors, but with a limited staff to mitigate the risk to our valued team. Our scientists were able to be present in the lab for essential project activities while all other team members worked from home. Prior to entering the Center, employees had their temperatures checked and were given protective masks.

To support ongoing and new projects, we always have sufficient materials available.  We formed a multi-functional team including representatives from regulatory, procurement, import/export and customs service to ensure the safe and timely arrival of materials, such as cells, from our customers.

We also have a robust quality system in place to assure the complete traceability and data integrity. Our quality team conducts inspections and reviews project data as we always have.

 

Q:  What precautions have been established to help ensure the safety of employees and customers?

A:  We have put in place an extensive set of procedures and precautions to help safeguard our employees and customers. Among these initiatives are:

Asymptomatic employees that are needed to support activities in the lab have returned with their manger’s approval; other employees can continue to work from home.

Employees are encouraged to drive to work and avoid public transportation.

Employees are required to wear face masks and have their temperatures taken before entering the Center.

Employees are expected to practice good personal hygiene and social distancing.

Public areas and offices are disinfected twice daily.

For the time being, visitors are asked not to come to the Center. If an onsite meeting cannot be avoided, visitors are asked to wear a mask, will have their temperature taken and asked about recent travel.

Employees interacting with contractors or suppliers are expected to wear a full set of personal protective equipment.

In addition to these policies, we have established an emergency response procedure should a team member become symptomatic.

 

Q:  Who was involved in developing new procedures and precautions for the Biodevelopment Center?

A:  We have the MilliporeSigma Emergency Response Team China (ERT) which included representatives from key functional areas to develop the crisis strategy which was then implemented by the Shanghai Center. The multi-disciplinary ERT team included members from procurement, legal, compliance, government affairs, corporate communication, human resources and finance, as well as our managing director and the head of our China office.  The ERT worked in close collaboration with our China Management Committee (CMC) and leadership from our Process Solutions division.

The mandate of this combined group was to establish procedures that enabled us to:

Track employee health on a daily basis

Ensure protection of the working environment

Remain updated on governmental policies

Understand and respond to customer needs

Evaluate and quantify the potential business impact

To facilitate and ensure timely communication across our organization, we established a WeChat group to provide daily updates via mobile phone to employees regarding news, policies and guidelines.

 

Q:  What do you feel were the keys to success during this time?

A:  Two aspects of our approach were essential to the continuation of projects and resumption of full services: 

Maintaining close and proactive communication both with employees and customers about decisions that were being made.

Recognizing that the health of our employees is our top priority. We were able to monitor the health of our team members and their family situations. The resulting reports and charts provided important guidance as to whether we could resume full operations and under what conditions. This focus guided our decisions and the timing related to the resumption of full services.

 

The pandemic has certainly been an unprecedented challenge for the entire world. As one of the world’s leading science and technology companies, we are dedicated to advancing the development and commercialization of new medicines for patients in need. The BioReliance® End-to-End Solutions team at our Shanghai Biodevelopment Center are to be commended for their dedication to our organization, their fellow employees, and of course, our customers.  We recognize the important work of our customers around the world, including many developing therapeutics to combat the pandemic, and remain committed to their success.