Manufacturing, Parenterals and Injectables

Given the criticality of fill/finish processes, it is clear that automation is the next technological step.

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

The newly established business under Advent International and Warburg Pincus will be named Simtra BioPharma Solutions.

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

Gerresheimer and Nelson Labs will work together to conduct extractables and leachables testing on upcoming primary packaging solutions.

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

Lubrizol has launched Apisolex technology to improve solubility and simplify the manufacturing of parenteral drug products.

Takeda’s TAKHZYRO prefilled syringe is now available for patients with hereditary angioedema aged 12 years and older in the United States.

Eli Lilly and Company is investing $1 billion to establish a new manufacturing site in Concord, NC, to manufacture parenteral products and devices.

Isolators move into smaller-volume processes, including cell and gene therapy manufacturing.

New equipment meets needs for faster vial labeling and RFID for unit-level serialization.

Trends and technologies in pharmaceutical manufacturing were highlighted on the show floor and in the conference sessions on the INTERPHEX Innovation Stage.

Baxter will invest $100 million in new lyophilization equipment and an additional aseptic syringe filling line at its Halle/Westfalen (Germany) location.

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

Conventional and robotic automation inside closed systems reduces risk.

Terumo Blood and Cell Technologies and PhotonPharma announced a collaboration to develop a novel tumor-specific immunotherapy for solid tumors.

Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.

GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.

In combination with etoposide and either carboplatin or cisplatin, Imfinzi has been approved in the first-line setting of ES-SCLC by China’s National Medical Products Administration.

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

Container and equipment innovations expand applications.

Amgen’s greenfield facility near Columbus, Ohio to assemble and package vials and syringes is expected to be operational by 2024.

Automation offers benefits for sterile manufacturing in 503B outsourcing facilities.

Advances in automation and cleanroom technology improve efficiency for small commercial quantities of aseptically filled drug products.

The semi-automated TipFil Syringe Filler from TurboFil Packaging Machines provides accurate and consistent fills.

Complex formulations, personalized medicines, COVID-19 therapies, and sustainability goals are driving innovations in drug packaging.

Material properties play a role in container closure integrity under frozen or cryogenic storage temperatures.

Intensified and distributed manufacturing approaches create flexible, local capacity.

The site, which is set to be operational in three years, will feature disposable technology and advanced technology filling lines to produce 90 million vials and 50 million pre-filled syringes a year.

The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.