The Medicine Maker

The Medicine Maker
Share

The Medicine Maker

 •  December 22, 2017

How a customer focused mission to boost single-use assembly product quality and supply security led to the Mobius® MyWay Program and a manufacturing site transformation.
Back in 2016, Merck began a multi-phase program to prepare themselves – and their customers – for a high quality, scalable and secure single-use future.Phase 1 of the “Mobius®...

The Medicine Maker

 •  December 22, 2017

Poloxamer 188 has become an essential component of cell culture media, but lot-to-lot variability has been a problem for many biopharma manufacturers. By working with customers directly we’re able to supply a product that can be trusted.
In previous articles in this series, my colleagues have discussed the importance of well-characterized raw...

The Medicine Maker

 •  December 21, 2017

Characterization and quality control (QC) regulations demand that manufacturers demonstrate consistency and control over the manufacturing process. To have the best chances of success in getting your biopharmaceutical molecule from development to regulatory approval, I believe it is imperative to think about “developability” and “manufacturability”...

The Medicine Maker

 •  December 21, 2017

Continuous manufacturing has been a growing trend in pharma for some time, but now researchers are urging cell therapy manufacturers to get in on the act. “Given the increase in the number and relative success of cell therapy clinical trials, treating a larger number of people is expected over the next decade,” says Che Connon, Professor of Tissue...

The Medicine Maker

 •  December 21, 2017

With extensive experience in vapor jet printing small molecular organic electronic materials, a team from the University of Michigan led by Max Shtein (professor of materials science and engineering) has more recently recognized that the technology could have potential in small-molecule drugs (1). By thermally evaporating an API into a stream of...

The Medicine Maker

 •  December 21, 2017

In November, the relocation of the European Medicines Agency (EMA) from London to Amsterdam was confirmed, with the loss of around 1000 UK-based jobs, many of which are highly skilled. The unsurprising but nevertheless bad news is a direct and inevitable consequence of Brexit, and there will certainly be further reaching effects on employment and...

The Medicine Maker

 •  December 21, 2017

Whether better ensuring patient safety, improving process efficiency, or just making life in the lab or facility easier – meet the companies advancing pharmaceutical development and manufacture. iQ™. The Global RTU Standard A holistic concept standardizing ready-to-use containers within a single tub format to run on the same filling line. A time...

The Medicine Maker

 •  December 21, 2017

Risk management has become an important discipline for firms developing new prescription drugs. It is said that only one of the 10,000 molecules entering drug discovery will ultimately reach the market – and, even then, it is not certain that expensive development costs will be recouped. There can be few industries where the risk of failure is...

The Medicine Maker

 •  December 4, 2017

What actually is next generation bioprocessing? How are industry players defining next generation bioprocessing and how will they pursue and successfully implement this approach? And is continuous bioprocessing always the ultimate end goal drug manufacturers around the globe are, or should be, striving for? In this dedicated supplement, experts...

The Medicine Maker

 •  November 28, 2017

Sara Bell is fortunate to have been on both sides of the fence, spending 11 years in operations at Amgen before joining Merck KGaA, where she is now Senior Marketing Manager of their single-use portfolio. Sara knows full well the challenges faced in biopharma manufacturing – and why single-use is seeing increased uptake. Here, we talk to Sara about...