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Demand for outsourced contract manufacturing in the pharmaceutical industry continues to grow, but what does it take to be a trusted partner?

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The current pharmaceutical industry landscape creates some interesting opportunities for CDMOs to grow and develop.

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In the last ten years, the contract manufacturing sector has experienced some major changes as a result of consolidation, increasing price pressures and evolving customer expectations.

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Amjad Alhalaweh, one of our formulation scientists at Recipharm, took part in the in-Pharma Technologist Drug Delivery online conference on Thursday 20th April, 2017.

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As the need to manufacture more challenging drugs for smaller patient populations increases so too does the demand for aseptic manufacturing.

Highly potent oncology drugs and injectables are driving the demand for CDMOs to meet the stringent regulatory requirements surrounding the manufacture of sterile products.  

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During the discovery and early stages of drug development the pharmacology, pharmacokinetics and toxicology of a compound are evaluated using a simple liquid formulation. However, low aqueous solubility can prove to be a major obstacle when it comes to the development of liquid formulations, so selecting the right excipients to help solubilise them is vital.

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The complexity of new molecules is fuelling the outsourcing of oral solid dosage (OSD) manufacture. Innovators are choosing to share the burden of challenges relating to bioavailability, formulation, stability, manufacturability and, not to mention, scalability.

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There is an opportunity for consolidation to help customers reduce their supplier base.

The trend of life science pharmaceutical companies partnering up with contract development and manufacturing organisations (CDMO) has grown as newer and smaller companies turn away from investing in large scale in-house production and instead outsource manufactur

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Scale, breadth and depth of services will always be key drivers for pharmaceutical outsourcing, and CDMOs that can offer a wide range of technologies and expertise are uniquely placed to act as a one-stop-shop partner.

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If the industry does not get to grips with serialisation soon, it could be too late.

With the US deadline for pharmaceutical serialisation just around the corner and the EU regulations due to come into force in 2019, track and trace implementation is set to be a major topic for 2017.