Manufacturing

Jacobs Engineering Group was awarded a contract to provide engineering services and procurement for Alnylam Pharmaceuticals’ new manufacturing facility in Norton, Massachusetts.

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

Three-dimensional printing allows unique benefits to be built in to solid-dosage forms.

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.

CMOs are working hard to improve performance by investigating new technologies for filtration and purification.

Regulators and manufacturers address economic and ethical issues for scarce medicines.

New technology introduced in 2016 aids innovation growth for pharmaceutical manufacturing.

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.

A Q&A with FDA to gain insight on FDA's views of three-dimensional printing and its regulation in drug manufacturing.

PharmTech’s 2016 survey shows general satisfaction with existing solid-dose and parenteral manufacturing equipment, and slow adoption of continuous manufacturing processes.

The acquisition will add to the company's cell therapy base and potential impact in treating rare diseases.

Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.

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.