MRNA & PLASMID DNA MANUFACTURING CLEANROOM FOR A BIOTECH CDMO скачать в хорошем качестве

MRNA & PLASMID DNA MANUFACTURING CLEANROOM FOR A BIOTECH CDMO

The pandemic has spawned many opportunities for innovation across several industries. This biotech company has become a key player in the biomanufacturing space, headquartered in Canada. The urgent need for vaccines created a booming demand for messenger RNA (mRNA) and plasmid DNA, and that’s where innovation starts! Our partner, a Canadian biotech contract development and manufacturing organization (CDMO), needed multiple cleanroom spaces to manufacture mRNA and plasmid DNA to meet the need for these resources to develop vaccines. Their biomanufacturing facility contains an ISO 6 fill/finish suite, three ISO 7 manufacturing laboratories, an ISO 7 master cell banking cleanroom, and an ISO 8 gowning room. The total size of the cleanroom area is 2,300 square feet. The mRNA and plasmid DNA manufacturing cleanrooms are GMP compliant, thanks to multiple good manufacturing practice features such as cleanroom coving, doors and pass-throughs with an interlocking system, and flush finish design. CLEANROOM PROJECT SUMMARY: 📍Location: Alberta, Canada 💼Industry: Biomanufacturing / Biotechnology 💉Application: DNA Plasmid & mRNA Manufacturing 📏Size: 2,300 Sq. Ft. 🥼Cleanroom Class: ISO 6, ISO 7 & ISO 8 (GMP Compliant) OVERCOMING CLEANROOM CHALLENGES WITH AGILE PROJECT MANAGEMENT Cleanrooms are rigorous environments where some standards and requirements need to be met without any compromise. Multiple things may go wrong if not planned accordingly. MECART is resourceful in finding solutions and alternatives for each challenge. MECART had to work with: a tight schedule problems related to the supply chain beyond our control due to the pandemic RAPID DELIVERY OF BIOTECHNOLOGY CLEANROOM FOR RAPID MARKET LAUNCH Our client had a quick time-to-market approach for their nucleic acid products. They wanted to hit the market with their mRNA cap analogs and plasmid-DNA as fast as possible. MECART’s customized, fast and high-quality approach to cleanroom manufacturing is perfect for cases like this. This isn’t the first time we’ve worked with a tight, aggressive schedule and come out on top! Our client’s words sum it up best. “The process was seamless. A site visit was quickly organized, and this allowed me to have personal rapport with the project managers. I feel a great sense of ownership from the project managers, so much that sometimes they feel like part of our team…it’s clear that they want us to succeed, and that means a lot to me,” said the VP of this biotechnology company. OVERCOMING SUPPLY CHAIN PROBLEMS THANKS TO IN-HOUSE EXPERTS The global supply chain is still being impacted by issues related to the COVID-19 pandemic, such as delays and interruptions. Almost every sector has been affected directly or indirectly by chain supply issues. In this situation, the HVAC required some items that were out of stock or had significant delays in delivery that jeopardized the final cleanroom project. Instead of accepting the harsh reality of broken supply chains, our in-house HVAC expert found a workaround to solve the problem. MECART has 20 engineers and multiple experts in various domains to solve problems like this, to meet your need for quick lead time! In the end, MECART met the requested delivery time, allowing the biotech CDMO to begin their mRNA and plasmid-DNA manufacturing in their brand new cleanroom facility. Mecart overcame all the challenges along the way. This allowed us to meet the requested lead time and meant our client could begin the mRNA and plasmid-DNA manufacturing in their pristine cleanroom facility. Above, there is a timelapse of the assembly of the modular cleanroom at the customer’s site.