Manufacturing, Parenterals and Injectables

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.

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.

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

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

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

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 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.

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.

The company has officially opened a local brand office in South Korean to support its existing business in the region.

The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

The company is investing EUR 170 million (US$201 million) to expand its vaccine manufacturing site in France for its newest influenza vaccine.

Manufacturers introduce innovations in glass and plastic packaging for injectables.

Focused around Purdue University’s LyoHUB, a new blueprint aims to bring innovation to equipment and processes. One goal? Continuous freeze drying.

Poly(lactide-glycolide) has been used for drug-delivery applications because of its beneficial physicochemical properties, long safety record, and reliable commercial supply.

Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.

Parenteral packaging will be well-represented at INTERPHEX, especially technologies associated with fill/finish of ready-to-use vials, cartridges, and syringes.