Pharmaceutical Technology Europe-08-01-2014

Pharmaceutical manufacturers will be-and are already&mdashfacing enormous challenges to implement the serialization regulations within the given timeframe.

Single-use technologies, which started off as a tool for small-volume solution storage and transport has now become the central, enabling technology around which manufacturing processes and facilities are being designed.

In the past 10 years, safety issues have become increasingly important in pharmaceutical packaging, from needle sticking safety to counterfeit protection.

Single-use technologies have gained broad acceptance in biomanufacturing within the past few years, supporting flexible and cost-effective clinical production.

New chemical entities with poor aqueous solubility require the use of technologies to enable sufficient oral bioavailability of these NCEs following administration.

Developments in chromatography column technology to deliver greater efficiency, speed and inertness benefit the drug development process from discovery to manufacturing and quality control.

Film coating for solid oral dosage forms provide important patient benefits while enhancing brand recognition and adding value to innovator, generic, over-the-counter and nutritional products.

With a number of branded biologics hanging at the patent cliff, the future looks promising for biosimilars.

The success of new biopharmaceutical drugs also relies on innovative solutions such as single-use technologies that suppliers have to offer to the pharmaceutical industry.

IPEC Europe continues to promote the quality, safety and functionality of excipients used in pharmaceutical products.

Innovative therapeutic approaches beyond mAbs will require new methods for future facility construction.

Tool coatings are now seen as an acceptable means of solving production problems, such as sticking and corrosion, resulting in increased product yield.

Quality by design, process analytical technology, and high throughput screening have helped drive progress in pharmaceutical development.

Experts discuss developments and future trends in prefilled syringes.

The European Union has developed a system for evaluating, approving and monitoring the safety of medicines that has also encouraged innovation.

Single use has introduced a level of flexibility into facilities that was either unheard of or very expensive in a stainless-steel environment.

Quality by Design has initiated a paradigm shift in solid dose pharmaceutical manufacturing.

A review of how mergers and acquisitions have shaped the pharmaceutical industry landscape.

Efforts to tackle challenges in tablet manufacture are shaped by quality by design (QbD) and continuous manufacturing.

Global harmonisation would help improve supply-chain security and reduce the flow of falsified and sub-standard medicine into Europe.

Continuous manufacturing is key to the future of pharmaceutical manufacturing.

To realise the full potential for biosimilars, stakeholders must build a better understanding of biosimilars and to take a comprehensive view of how these important medicines can fit into treatment pathways.

Stephen Tindal from Catalent Pharma Solutions speaks with Pharmaceutical Technology Europe about advances in softgel technologies.

The EXCiPACT Certification Scheme ensures patient safety through supplier quality while minimising the audit burden and overall costs for assessing the excipient supply chain.

A breach in the pharmaceutical supply chain is only the tip of the iceberg.

Softgels are now being recognised as one of the preferred dosage forms for the treatment of pain, eye conditions, cough and cold, as well as allergy.

Eric Langer of BioPlan Associates describes the development of biopharmaceutical outsourcing in Europe over the past 25 years.

Pharmaceutical Technology Europe marks its 25th anniversary.

A diverse range of particle sizing solutions is available, from techniques for the characterization of complex formulations through to online PAT tools for real-time measurement.

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