Manufacturing

Better process development is creating industry benchmarks for bioprocessing.

Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.

Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.

Industry experts share insights on the advances in tablet coating technologies and the potential of continuous coating in solid-dosage manufacturing.

Prexima 80 is designed for R&D and small batch production; the single-sided Prexima 300 is for medium production output; and the double-sided Prexima 800 is for high production output.

GEA has entered into a collaboration with GSK to further develop self-contained, POD-based mini-factories for the manufacture pharmaceutical oral solid dosage forms.

While biologics development grabs investor interest, small-molecule APIs still hold two-thirds of the drug-development pipeline.

The Transform hydrate-able film from Lubrizol LifeSciences is compatible with a range of APIs.

Sartorius Stedim Biotech’s Flexsafe 3D Pre-designed Solutions meet ASTM D4169 Standard Practice requirements and are designed for storage and shipping of biopharmaceutical fluids.

IMA Active’s new tablet press machine, Prexima, is designed to deliver higher productivity and efficiency.

Ross’ Batch High Shear Mixer features a four-blade rotor running within a close-tolerance stator at variable tip speeds up to 3000-4000 ft/min.

Although shortages, quality, and regulatory challenges remain, improved technologies and new investments suggest that the worst may be over.

Miriam Beyer, European marketing manager, West Pharmaceutical Services, describes causes of recent parenteral drug shortages.

Catalent Pharma Solutions announced plans to quadruple the cold-chain capacity at its existing clinical supply storage and distribution facility in Shanghai, China. The expansion comes in response to increasing demand from domestic and multinational pharmaceutical sponsors and contract research organizations (CROs).

USP responds to FDA's draft guidance on the naming of biological products.

Rx-360 announced that Mark S. Paxton has been appointed as the new chief executive office of the international pharmaceutical supply chain consortium. This appointment follows the successful growth of Rx-360 since its foundation in 2009 in the aftermath of the adulterated heparin tragedy. Rx-360 has 300 volunteers from more than 100 institutions that are organized in 17 working groups with activities in the US, Europe, China, and India.

According to a third-quarter earnings report, Pfizer’s vaccine business contributed nearly 14% to its total revenue.

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

An industry-led strategy was launched in September 2015, in which senior experts from life-sciences and chemical companies set out how Scotland provides the infrastructure, connectivity, and academic excellence necessary to sustain a thriving manufacturing base.

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

Employing continuous manufacturing and data analytics will help improve the efficiency of pharmaceutical manufacturing in the facility of the future.

The agency gives an update on the regulation of combination medical products.

The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.

The site is expected to become fully operational in 2017 and will produce approximately 40 million packs and 850 million tablets of some 30 innovative medicines every year.

Flexsafe 3D Pre-Designed Solutions feature appropriate components, functionalities, and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling.

Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.

At CPhI Worldwide 2015, The Dow Chemical Company announced the global commercial availability of AFFINISOL HPMC HME, a new generation of cellulosic polymer for drug solubilization. The polymer is designed for use by pharmaceutical companies looking to enhance the solubilization and inhibit the recrystallization of APIs in hot-melt extrusion (HME) formulations.

The Quad Pulse Package PX dust collector from Camfil Air Pollution Control is a compact unit for processes that produce hazardous dusts in high concentrations, with a cleanable filter system that facilitates continuous manufacturing.

Steris Corporation’s steam sterilizer provides reliable decontamination for high-containment facilities.

Ajinomoto Althea, a biopharmaceutical CDMO, is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates (ADCs), the company announced on Oct. 14, 2015. The new facility is located in close proximity to the company’s existing operations in San Diego, CA.