Felicity Thomas

Drug companies will have to sharpen their understanding of evolving E&L regulatory expectations in order to remain compliant.

Biologics raise unique formulation and development challenges, and industry is still on a learning curve to get the best out of these diverse and complex therapies.

As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.

Regulatory mandates, niche diseases, and patient-centric solutions have all impacted pharma packaging over the years and are expected to help shape the future of the sector.

PTE looks ahead to 2020’s edition of Pharmapack-the pharma industry’s dedicated packaging and drug delivery event.

Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market.

As the UK heads to the polls for an unusual December general election, industry issues manifestos on medicines while Europe rejoices some movement … finally.

Spray drying is a versatile and rapid technique that can provide companies with a suitable and scalable option to improve the solubility and bioavailability of drug products.

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.

Industry experts examine the fundamentals of dissolution testing, including challenges resulting from an increasing number of poorly soluble molecules under development in the pharmaceutical pipeline.

After years of discussions around pricing, UK governmental bodies and Vertex have finally reached an agreement on cystic fibrosis treatments.

Palatability is crucial for adherence and compliance to oral drug regimens.

A complete understanding of primary packaging physicochemical properties is necessary in the formulation and development of biologics.

With no plausibly approvable deal on the table in the UK government at the moment, it is possible that Brexit could be extended even further.

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.

Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.

As the development pipeline becomes more saturated with complex molecules and patient experience becomes more important, developers are looking to outsourcing partners to provide more specialized expertise and solutions.

Radio-frequency identification on packages aid drug supply-chain security.

Government statistics show that pharma can be an illustrious career for graduates, which must be taken advantage of by industry to avoid skills shortages.

As a potential ‘no-deal’ Brexit looms, pharma companies and industry bodies are preparing for the worst-case scenario but hoping that the UK won’t end up with a disorderly exit from the EU.

In this interview, the main uses and benefits of NIR spectroscopy in tableting are discussed.

Regulatory bodies are taking a more stringent approach to excipient quality, but unlike guidance on GMP for APIs, those for excipients offer a framework only, meaning the onus lies with the manufacturer or supplier.

As vaccines gain prominence within pharma, there is an expectation that specialized CDMO services will provide opportunities.

Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.

The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.

Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.

To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.

Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.

Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.

Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.