Manufacturing

A techno-economic profiling method supports pharmaceutical process development by helping identify the best manufacturing approach.

The US federal Drug Quality and Security Act (DQSA) and more specifically the Drug Supply Chain Security Act (DSCSA), referring to Title II of the law, requires phase-in of requirements to prevent counterfeiting. An expert discusses how companies should be preparing to meet the requirements of the DSCSA.

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.

Hovione announced that its API plant in Cork, Ireland has successfully passed a pre-approval inspection by FDA.

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

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.

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.

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.

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.

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

Continuous manufacturing is key to the future of pharmaceutical manufacturing.

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.

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.

Contract research, development, and manufacturing organizations invested in new facilities and technologies in 2014 for analytical testing, as well as small- and large-molecule drug development.

Contract service providers describe how quality by design has influenced a drug sponsor's expectations of suppliers.

Representatives of contract service organizations that develop biologic-based drugs discussed technology trends such as high-throughput screening and single-use systems.

Contract services ride high as funding floods bio/pharma.

Representatives of contract service organizations that specialize in parenteral drug development and manufacturing describe the evolving trends.

Despite the growth of specialist companies with capabilities across various therapeutic areas in Europe, there is still a need for early development expertise with end-to-end pharmaceutical manufacturing capabilities.

Contract development and manufacturing organizations identify trends, challenges, and emerging technology and service needs for solid and semi-solid dosage forms.

For a bio/pharma industry in flux, contract services are playing a greater-and more diverse-role in drug development.

Pfizer announced an agreement to acquire Baxter International?s marketed vaccines for $635 million.

The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

Packaging Coordinators, Inc. expands its services with acquisition of Penn Pharmaceutical Services.