Formulation and Drug Delivery

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.

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.

Industry experts discuss key considerations in the development of orally disintegrating tablets.

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

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

FDA and industry seek speedy Congressional approval of new user fee plan.

The affinity purification company will set up shop at the former Merck & Co./GlycoFi facility in the Dartmouth Regional Technology Center in New Hampshire.

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.

Gamma-stable fluoropolymers are an alternative material for single-use bags and assemblies in biopharmaceutical manufacturing.

The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immune-oncology.

The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

A new study examines the oral delivery of protein drugs in plant cells and hypothesizes that the cold storage and transportation of biologics could someday be eliminated.

FDA reviewers have found that Sandoz's GP2015, a biosimilar version of Amgen's Enbrel, is highly similar to the original product in terms of purity, safety, and potency.

A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.

The assay will provide information on biosimilar comparability.

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

Teligent is expanding its manufacturing and R&D complex in New Jersey.

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

Early planning for the integration of clean-in-place systems for equipment cleaning is key.

CPhI Pharma Awards seek nominations for excellence in development and manufacturing.

Polymers have played a key role as solubilizing excipients. Industry experts explain why polymer structures and functionalities are important considerations in formulation development.

Lipid-based drug delivery is increasingly being used to tackle oral bioavailability challenges resulting from poor solubility.

Aseptic spray drying provides an alternative to lyophilization as an enabling stabilization technology for parenteral biologic formulations.

FDA approved the Raplixa, the first spray-dried fibrin sealant, in May 2015 to help control bleeding in adults during surgery.

The Titan syringe pump from Syrris is a continuous-flow chemical processing module designed for lab, pilot, and production-scale applications.