The Medicine Maker

The Medicine Maker
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The Medicine Maker

 •  August 9

Biological drugs have undoubtedly revolutionized treatment (and the pharma industry), but there is a downside – cost. The complex manufacturing processes and quality control required to develop safe and effective biopharma medicines tend to result in expensive final products, causing problems for cash-strapped healthcare systems (and negative media...

The Medicine Maker

 •  August 9

According to the FDA, continuous manufacturing has many advantages... greater consistency in product quality, reduced inventory, lower capital costs, a smaller ecological footprint, minimized manual handling, shorter process times through integrated processing, the ability to employ real-time release testing approaches... In essence, continuous...

The Medicine Maker

 •  August 9

In June 2016, the FDA announced new draft guidance on reducing elemental impurities in drug products. Elemental impurities can make their way into a drug product from various points in manufacturing processes – and in some cases can be a risk to patients. The aim of the guidance is to help manufacturers of both new and generic small-molecule drugs...

The Medicine Maker

 •  August 9

A collaboration between The Dow Chemical Company and University of Minnesota has yielded a new method allowing the production of excipients that triple the oral bioavailability of drugs, when compared with commercial excipients (1). To further investigate their work, we speak with Theresa Reineke, a professor at the University of Minnesota and Jodi...

The Medicine Maker

 •  August 9

Every molecule – large and small – has a structure that drives its physicochemical and biopharmaceutical characteristics – and its potential as an active ingredient. The smoothest path to market lies in understanding your molecule’s characteristics and applying strategies to overcome any deficiencies as early as possible. With sound expertise and...

The Medicine Maker

 •  August 9

Blockchain – also known as “distributed ledger technology” (DLT) – is essentially a big record book. A DLT acts as a decentralized, digital journal where transactions and data are recorded across many computers or nodes, so records cannot be altered retroactively or individually. Data or transactions are stored in “blocks” on a blockchain, and it...

The Medicine Maker

 •  August 9

Eight trade associations representing the European and British pharmaceutical industries have written to Brexit negotiators, Michel Barnier and David Davis, to underline the importance of close cooperation between the EU and the UK on medicines (1). The letter warned against an “unorderly withdrawal” that would risk medicines being held up at EU/UK...

The Medicine Maker

 •  August 9

President Donald Trump’s budget request for 2018 caused a huge stir in the scientific community because of its potential impact on research. Funding for a number of agencies has been cut, including the National Institutes of Health (NIH). The NIH’s proposed 2018 budget is $26.9 billion, down from $34.6 billion in 2017. All eyes will now be on...

The Medicine Maker

 •  June 26

Serialization deadlines are nigh; the US regulations, part of the Drug Supply Chain Security Act (DSCSA), come into force in November this year – and any company with a commercialized product in this market will need to be compliant, meaning that manufacturers, contract packaging companies, wholesalers and distributors must all be able to exchange...

The Medicine Maker

 •  June 26

In my last article (1), I discussed the benefits of surface plasmon resonance (SPR). As a quick recap, SPR has been around for over 25 years and, in particular, has become a popular method for characterizing biotherapeutics and biosimilars. SPR is label-free, allows for real-time analysis and can characterize binding in terms of kinetics and...