Manufacturing

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.

Process analytical technology is crucial for understanding a pharmaceutical or biopharmaceutical process. Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

To enable efficient monitoring systems, life-science companies need to effectively apply run rules.

The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

Novo Nordisk plans to invest approximately $2 billion over the next five years in new production facilities in Clayton, North Carolina, US and Måløv, Denmark. The facilities are expected to be operational during 2020.

Mayne Pharma plans to double oral-dose manufacturing space and expand contract services.

Recipharm will be responsible for the supply of the remaining clinical-trial material and ongoing future commercial supply of RHB-105, the lead drug candidate developed by RedHill for the treatment of Helicobacter pylori bacterial infection.

Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA

Shire requests a technical transfer from Sanquin to widen its manufacturer base for the production of Cinryze.

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.

Allergan issued a voluntary nationwide recall in the US of specific lots of ophthalmic ointment after customers complained of black particles, which came from the cap.

Elizabeth Scheu & Kniss will supply replacement parts for Bosch capsule filling machines.

Biopharmaceutical company BeiGene plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.

Virtual pilot programs that simulate scenarios can help the pharmaceutical industry address core issues in the implementation of serialization systems that comply with the US Drug Supply Chain Security Act.

MES has already rewarded early adopters by reducing errors; next-generation technology will enable broader data analysis.

Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

Kate Kuhrt, senior director, Generics and Biotech, Thomson Reuters, spoke with Pharmaceutical Technology Europe about sourcing trends, supply chain challenges, the emerging market outlook, and how it affects European pharmaceutical manufacturers.

GSK reports no employee injuries at the facility and is assessing damage.

The complex task of stabilizing proteins is made more challenging due to the limited number of approved excipients.

The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.

The expansion will enable relocation of its North American headquarters from Grayslake, Illinois.

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).

WuXi PharmaTech and TruTag Technologies successfully applied and detected TruTag's edible microtags on solid-dosage drug products and found no effect on dissolution.

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

The reconfigured Sartobind membrane adsorber capsules from Sartorius Stedim Biotech is said to have higher binding capacities, reduced void volumes, as well as consume less buffer, enabling lower operational costs.

Catalent selects advisory board members to complement Redwood Bioscience Scientific Advisory Board.

GEA's self-contained homogenizer is designed for laboratory applications, including cell dispersions.

The Alpha agitator bead mill from Netzch is designed to mount different grinding systems on the same base platform.