Finding the Right CDMO Partner for Tech Transfer

By Emergent CDMO on Nov 18, 2021 4:32:34 PM

Regardless of where a drug candidate is in the development pipeline, performing a technology transfer (tech transfer) presents unique challenges for the partners involved.

Overcoming these challenges is critical to ensuring the ultimate success of the product when working with a Contract Development and Manufacturing Organization (CDMO). There are a myriad of ways in which a tech transfer can fail to meet its potential – unsatisfactory yields, unforeseen materials shortages, unoptimized batch sizes that can impact the quality and timelines of the transferred product.

Topics: Drug Product Fill/Finish White Papers

Benefits of RABS and Isolator Technology in a Changing Regulatory Landscape

By Emergent CDMO on Aug 19, 2021 2:19:21 PM

Mitigating risk is a key consideration for biopharmaceutical companies when planning their clinical trial material and/or drug product manufacturing processes. One of the most prevalent sources is material handling: every step in the drug substance or drug product manufacturing process can introduce risk.

Biopharma innovators and contract development and manufacturing organizations (CDMOs) collaborate to ensure a number of technologies are utilized to safeguard the integrity of these products. One method is to leverage a Restricted Access Barrier System (RABS) or isolator technology during drug product manufacturing.

Download our white paper to learn more about RABS and isolator technologies, similarities, differences, and benefits, and how Emergent CDMO's vast expertise and experience can help support your drug product manufacturing and packaging needs.

DOWNLOAD WHITE PAPER

Topics: Drug Product Fill/Finish White Papers
1 min read

Arrival of the Groninger INTEGRA

By Emergent CDMO on Jul 23, 2021 11:18:00 AM

With the expansion of our viral drug product manufacturing facility in Rockville, Maryland well underway, we have begun outfitting our new viral manufacturing suites. The Groninger® INTEGRA, a state-of-the-art high speed fill/finish line with fully integrated isolator technology and automated inspection, labeling, and packaging, recently made it's journey from Germany to the US. The INTEGRA is an integral part of our strategic plan to continue supporting our clients in the fight against the COVID-19 pandemic and other life-threatening viral diseases. Since arriving at our facility, the Emergent team has been working diligently to complete installation and qualification of the new line and progress continues. 

Check out a few photos of the INTEGRA being shipped to Emergent! 

Topics: Drug Product Viral Manufacturing
2 min read

Supporting the Production of Next-Gen Therapies

By Emergent CDMO on May 27, 2021 12:46:37 PM

“The Vanrx SA25 Aseptic Filling Workcell is a state-of-the-art machine, providing our clients with a high level of sterility assurance and flexibility through an automated handling, filling, and closing process, designed to minimize line losses. If you have a high-value product and require a small-to-moderate batch size, the Vanrx may be the ideal fit for your program.”

- Kevin Gadient
Director, Manufacturing Sciences & Technology 

Topics: Drug Product Fill/Finish

Rockville, MD Expansion Progress

By Catherine Hanley on May 12, 2021 3:56:00 PM

Our drug product manufacturing facility in Rockville, Maryland is undergoing an expansion that will soon house a state-of-the-art high speed fill/finish line with fully integrated isolator technology and an automated inspection, labeling, and packaging line. Take a look at the time lapse video of our progress so far!

Rockville CDMO Expansion
Topics: Drug Product Fill/Finish
1 min read

Ondemand Webinar: ENHANCING OUR CAPABILITIES FOR ASEPTIC FILL / FINISH PROCESSING

By Catherine Hanley on Apr 14, 2021 11:47:00 AM

Watch our latest webinar on the topic of aseptic fill/finish and isolator-based technology for pre-sterilized syringes, cartridges, and vials.

Topics: webinar Drug Product Fill/Finish

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