Manufacturing

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.

The joint marketing agreement allows the companies to expand dedicated blister feed system technologies.

The new sugars are touted to increase the efficacy of active pharmaceutical ingredients and improve cell culture yield.

In the past, contract manufacturing organizations (CMOs) and contract development manufacturing organizations (CDMOs) have been focused most on achieving scale, reaching new clients in new geographic regions, and adding services that were previously unavailable, according to Gil Y. Roth, president of the Pharma and Biopharma Outsourcing Association. In a new report from CPhI, Roth explicates how consolidation has changed how CMOs position their services to clients and how CMOs add value to their businesses.

Upgrades to Mettler Toledo’s weighing and dosing equipment increase productivity using lean laboratory principles.

Cell Therapy Catapult will provide manufacturing scale-up services to enable Asterias’ future clinical trials and commercial supply for Asterias’ allogeneic dendritic cell immunotherapy, AST-VAC2.

Contract manufacturer PiazaBio announces services for Western Pharma companies seeking to enter the China market.

The high cost of disposables is a factor in restricting adoption of single-use devices.

The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.

Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer’s disease.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

The PDA report discusses qualification and operational handling of passive thermal protection systems.

Multi-faceted powder characterization, including measurement of dynamic properties, can be used to correlate powder properties and process performance to support equipment selection, optimization, and troubleshooting.

Manufacturers of parenteral drugs face challenges to increase efficiency, control particulates, control extractables and leachables, and eliminate product/package interactions; new containers and packaging equipment offer increased options.

The complexity of new packaging regulations laid out in the Falsified Medicines Directive could threaten the existence of smaller pharma and packaging companies.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss performing investigations of biological products.

FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.

Despite emergence of biologics, small-molecule APIs benefit from industry growth.

The Alpha modular machine platform from Netzsch is designed to mount different grinding systems on the same base platform as appropriate for a defined drive capacity.

GEA’s Pony NS2006L is a self-contained, high-pressure laboratory and pilot plant homogenizer for product development of advanced fluid applications.

The flexible Dolomite Flow Chemistry Systems from Dolomite Microfluidics can be configured to suit different applications.

An integrated approach can improve the efficiency of cleaning validation studies.