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Erik Haeffler, Vice President of Manufacturing Services and Head of CSR at Recipharm, discusses the DSCSA enforcement delay with Contract Pharma and outlines what companies should be doing now to ensure they are ready ahead of the deadline next year.

Despite the FDA’s decision to delay the active enforcement of the Drug Supply Chain Security Act (DSCSA) in the US until 2018, companies need to continue to press ahead with their preparations for serialisation. 

Recipharm’s Torkel Gren joins Synthonics and Rush University representatives to discuss a new technology that improves pharmacokinetic (PK) properties in metal coordinated pharmaceuticals (MCPs).

Contract Pharma held a roundtable with industry experts from across the contract development and manufacturing space to explore current and future outsourcing relationships within the pharmaceutical industry.

The US Food and Drug Administration (FDA) has made the decision to delay the active enforcement of the Drug Supply Chain Security Act (DSCSA), aimed at combatting the issue of counterfeit medicines entering the supply chain.

With the deadline for new regulations on serialisation looming closer for both the US and European markets, the biggest challenge many pharmaceutical companies face is time.

Oncopeptides have collaborated with Recipharm to help bring their anti-cancer treatment to life.

Oncopeptides is a clinical stage company that is developing a molecule for oncologyindications. The molecule, which originated at Uppsala University, Sweden and the Karolinska Institute, is focused on multiple myeloma as a first indication.

Serialisation represents a significant challenge for CDMOs, with multiple factors to consider, from varying market regulations to data storage and exchange.  

With US serialisation requirements about to come into force and EU regulations on the horizon, more and more businesses are considering what track and trace could mean for them beyond compliance.

ABSTRACT: Aminopeptidases like aminopeptidase N (APN, also known as CD13) play an important role not only in normal cellular functioning but also in the development of cancer, including processes like tumor cell invasion, differentiation, proliferation, apoptosis, motility, and angiogenesis.