Manufacturing

UPS Temperature True Packaging provides four prequalified packaging system options for temperature-sensitive products with different time and temperature requirements.

Changsung's Gel Reclaim System (GRS) recovers gelatin scrap from a soft gel line.

Thermo Fisher Scientific adds Advanced Scientific’s custom single-use systems and equipment to its bioprocessing offerings.

Aesica announced that it received continuing approvals from FDA for its bulk manufacturing and packaging operations in Germany.

The Shantha facility will be Sanofi's second, in addition to its site in Frankfurt, for production of Insuman insulin.

The pharmaceutical supply chain continues to be a challenge for the industry despite advances in QbD and PAT.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.

Tooling can be damaged by poor handling or problems in process design or material choice.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

Market forces may limit the success of CMOs.

Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.

New guidelines focused on the materials of construction in biologic therapy packaging will help vendors prepare comprehensive extractable and leachable testing strategies.

Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, cost of goods, and sustainability from the start.

CMO executives share their opinions on where outsourcing is going and what is driving market change.

After launching a new mammalian cell platform, FUJIFILM Diosynth Biotechnologies U.S.A., has acquired fast-track vaccine manufacturing knowhow and a major presence in Texas’ emerging biocorridor with Kalon, its first acquisition.

Better equipment and automated processes will be key. So, too, will the right way of approaching outsourcing relationships.

Catalent will add potent containment for blending and granulation at its New Jersey manufacturing Center of Excellence.

Recipharm has completed a serialization project for China on behalf of one of its customers.

Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.

A draft NIOSH Current Intelligence Bulletin on recommendations for reducing worker exposure to reproductive risks of drugs is available for public comment.

Rommelag's all-electric aseptic blow-fill-seal packaging system encapsulates the filling point and can be installed in a cleanroom.

A horizontal flow wrapper separates vials and individually packs them at high speed using a long-dwell sealing system with ultrasonic or heat-sealing technology.