Manufacturing

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.

Pre-sterilized, nested syringes and vials are seeing increased use in sterile filling.

Comar's 18-mm SecureCap child-resistant closure for eye drops and nasal sprays meets US Consumer Product Safety Commission for products containing 0.08 milligrams or more of imidazolines.

Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board. The Pharma & Biopharma Outsourcing Association (PBOA) has announced that Nelson Patterson, vice-president, sales and marketing at Baxter BioPharma Solutions, has been elected to its Board of Trustees, effective immediately. Patterson was elected after Baxter BioPharma Solutions joined the PBOA as a Sustaining Member.

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

Child-resistant packaging requirements for products containing a specified imidazoline will come into effect June 10, 2015.

Single-use components aid efficiency in automated personalized therapy manufacturing.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

The acquisition of Aptuit's Glasgow, UK and Indiana, US facilities will add sterile injectable formulation development and expand AMRI's analytical services capabilities.

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

New materials and software modeling streamline the blister-package design process.

There are significant differences between small molecules and biologics fill/finish capacity.

Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.