Bold ventures in contract manufacturing

Feb. 10, 2022
Three CDMOs willing to chart new paths


It’s the willingness to jump in the rough waters of a public health crisis. It’s unraveling the unknowns of bringing novel and orphan drugs to market. It’s the desire to harness new technologies that could lead to more sustainable and affordable drugs.

In many ways, the pandemic has reignited and reaffirmed the pharma industry’s passion for finding innovative ways to improve patient health. From novel gene therapies with the power to cure deadly genetic diseases to lifesaving treatments and vaccines for infectious diseases — it’s a thrilling time to be in this industry.

This enthusiasm has boiled over into the contract manufacturing space, where the deal-making and momentum are flowing. New, complex therapies coming through the pipelines are putting immense pressure on supply chains and manufacturing capacity, challenging traditional scale-up and manufacturing processes at the same time — and CDMOs have stepped up into the thick of it all.

This series profiles three CDMOs willing to take on projects with higher chances of failure, boldly pushing the boundaries of the ‘risk-averse’ pharma industry.

Breaking our own tradition here at Pharma Manufacturing, we decided to re-profile Emergent BioSolutions. Last year, in our January issue, we took a closer look at the busy Bayview plant, where employees were working around the clock to produce drug substances for two different COVID vaccines at breakneck speeds. Shortly after we went to press, a lot would change for Emergent.

This year, we sat down with Emergent to re-assess. How did the biodefense powerhouse get its disgraced Bayview facility back up to speed? And perhaps more importantly, what has this experience taught Emergent — and the country — about how to better prepare for the next pandemic? This year’s profile is, very appropriately, a story about how to re-emerge stronger.

It’s easy to forget that in addition to meeting the demands of an ongoing pandemic, pharma is tasked with resolving unmet needs in rare disease treatment. Fortunately, many drug developers are pushing to deliver transformative therapies to suffering patients as quickly and safely as possible. But steering orphan drugs from discovery to market is an ambitious undertaking. AGC Biologics prides itself in tackling complex molecules and despite challenges, continues to welcome partnerships in the niche orphan drug space. This profile highlights what it takes to guide clients through the complexities of orphan drugs, from the lens of a CDMO with multiple successes under its belt.

In conversation with Sterling Pharma Solutions, we continued to see this motif of determination and positive disruption. If there is a promising innovation out there, Sterling will find a way for pharma to use it. With a program dedicated to scouting out the best ways to implement new technologies for continuous improvement and a handpicked network of academic partners, Sterling is helping pave better ways for drug development and manufacturing. This profile highlights Sterling’s efforts in the promising area of biocatalysis and how this is facilitating greater global access to lifesaving antivirals.

[Part 1] The path to re-emergence: How Emergent BioSolutions put itself — and pandemic preparedness — on a better course
[Part 2] Mapping uncharted territories of rare disease: AGC Biologics has an aptitude for guiding developers through the complexities of orphan drugs
[Part 3] Paving a better way: How Sterling Pharma Solutions' dedication to technology is making a global impact

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'