Drug Development

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.

New legislation and changes in policy at FDA are leading to better control of the API supply chain.

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the manufacturing process following a change in the manufacturer.

Multivariate data analysis (MVDA) is being used to effectively handle complex datasets generated by process analytical technology (PAT) in biopharmaceutical process development and manufacturing.

A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.

The White House confirmed that it would release a plan to tackle the growing problem of antibiotic-resistant superbugs.

Bristol-Myers Squibb acquired an exclusive license for Novo Nordisk’s discovery biologics research program.

Use of modeling software can help improve process understanding, and can be used in open- or closed-loop control.

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.

Real-time, noncontact imaging and spectroscopy techniques provide insight into pharmaceutical processes.

Several chromatographic resins are available for downstream purification.

Sharon Johnson, senior vice president, Global Quality & Regulatory Affairs, will head the organization.

NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.

Innovative equipment, analytical techniques, software, and modeling systems are improving the tableting process.

Taste may be subjective, but it is crucial to patient compliance, particularly for pediatric treatments.

Analytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.

Ionic liquid technologies offer a new way to improve bioavailability.

New cellulosic polymers have been shown to improve solubility in these key amorphous solid dispersion processes.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

Protecting workers, patients, and the environment requires advanced technologies.

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

While the skin offers an alternative route of administration for local and systemic drug delivery, developing semi-solid dosage forms can be a challenge.

Several chromatographic resins are available for downstream purification.

It is vital that companies involved in the manufacturing and handling of cytotoxic drugs ensure that staff are given the highest possible levels of protection.