Manufacturing

Recent revisions to the European Union’s good distribution practices, which were updated in 2013, reflect increased regulatory focus on the supply chain.

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

An MIT-developed system uses microbes for manufacturing small amounts of vaccines and other therapies.

Stability testing programs should provide drug owners the information needed to establish the proper handling, shipping, and shelf-life recommendations for drug products.

The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties. \

Quality, innovation, and new approval pathways open drug development options for the Chinese market, including injectable contract manufacturing.

Bio/pharmaceutical contract service provides continue to invest in development, facility upgrades, technological advancement, and mergers and acquisitions.

New approaches add flexibility and reduce risk for contract development and manufacturing organizations (CDMOs) and their clients.

While isolators may offer advantages in high-speed commercial manufacturing lines, RABS continues to be a flexible alternative solution for small-scale production of drugs for clinical use.

Planning ahead is key to enabling a continuous and secure supply chain that adapts to changes in market demand.

Now past the “wait-and-see” standoff, most pharmaceutical companies and their contract partners are considering long-term requirements, including distributors’ needs.

The author reviews some of the key considerations when selecting a vendor and crucial parameters that must be defined in the tech-transfer process to ensure the greatest chance of success.

Training and mock audits are the key to preventing data integrity issues with partners offshore, but the process must start at home. Compliance consultant John Avellanet shares best practices and ways to minimize costs.

Multiple methods are required for detecting and removing protein impurities.

The investment will be spread across three sites: Barnard Castle in County Durham; Montrose, Scotland; and Ware, Hertfordshire.

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.The recent resurgence of yellow fever incidences over the past six months has prompted health officials to ramp up the fight against the virus. Like the Zika virus, yellow fever is transmitted primarily through the bite of infected female Aedes aegypti mosquitoes.

The project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator to achieve an occupational exposure limit of less than 1 microgram per meter cube, 8-hour time weighted average.

The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

Zenith appointed Carlos Machado as serialization director to lead the company’s sales, operations, and post project support services.

The company manufactures biological drug products and intermediates for the allergy vaccine market.

The company voluntarily recalls all lots of lyophilized HCG and sermorelin.

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.