Manufacturing, Parenterals and Injectables

Telstar has a dedicated process analytical technology (PAT) corner at its booth to display new developments for pharmaceutical freeze drying systems and aseptic manufacturing processes.

The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.

Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.

Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.

Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.

Grand River Aseptic Manufacturing announces equipment purchase to add vial filling capacity.

INTERPHEX presents advances in pharmaceutical container filling, robotic handling, and serialization.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

The company will build a high-volume manufacturing facility for their glass packaging product in Durham County, NC.

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

New filling and inspection machines and new containers and closures for injectable drugs will be on display at INTERPHEX 2018.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

The active pharmaceutical ingredient and excipient provider has expanded its parenteral ingredient manufacturing capacity and lab services.

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.

Grand River Aseptic Manufacturing announces first planned investment in capacity expansion.

Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully.

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

The Flexicon PF7 peristaltic tabletop aseptic liquid-filling machine from Watson-Marlow Fluid Technology Group is suitable for GMP-regulated biotechnology and pharmaceutical operations.

A manufacturing disruption has led to an EpiPen shortage in Canada, which currently has no alternative auto-injectors available on the market.

Meissner Filtration Products has acquired PDC Aseptic Filling Systems, a supplier of aseptic filling systems and sealers, to expand Meissner's automated platform offerings.

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

Measurements by a drone-based online pressure monitoring system help identify weak points in the filling line, enabling the process to be optimized.

Sterile-molded filling assemblies from AdvantaPure are suited for single-use vial and syringe filling.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.

The company will expand two of its Ohio facilities, investing approximately $145 million to support manufacturing and warehouse operations.

In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.