Manufacturing, Parenterals and Injectables

Use of a small-scale filler can result in increased filling efficiency.

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 stie in Concord, N.C., to manufacture parenteral products and devices.

Build into the chemistry, manufacturing, and control strategy the ability to pivot and be flexible should the course change.

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

A coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.

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.

Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.

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.

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

Container and equipment innovations expand applications.

A best practices approach to pharma’s most challenging-to-inspect container.

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.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

Alcami will provide services for Trevena’s OLINVYK (oliceridine) injection, an opioid approved for the management of acute pain severe enough to require an intravenous opioid analgesic in adults.

Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.

The agreement will accelerate production of SiO2’s plastic vials for vaccines and therapeutics for Operation Warp Speed.

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines.

Risk aversion is impeding the use of closed aseptic systems, and adding unnecessary cost and complexity to aseptic operations in the pharma industry.

FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.

The industry’s aversion to risk has led to its treating closed aseptic processing systems as miniature cleanrooms, resulting in redundant and expensive practices. This article ponders this impasse, examining new technologies and applications in light of past regulatory guidance and more than 40 years of operating evidence.