Manufacturing, Drug Products

The companies will utilize Avid’s upstream and downstream process development and drug substance manufacturing services in conjunction with Argonaut’s parenteral drug product fill-finish services for the delivery of CGMP parenteral drug products for use in clinical studies.

Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial.

Filling and packaging of primary containers is a crucial piece of COVID-19 vaccine and therapeutic production.

Using a specific addition method to wet the powder bed in twin-screw granulation using a foam binder improves robustness for continuous solid-dosage drug product manufacturing.

Aji Bio-Pharma launched Ajility, a flexible platform for manufacturing vaccines and therapies.

Consider how to assess risks and understand possible sources of disinfectant residues in pharmaceutical manufacturing.

Leadership was announced for the US government’s Operation Warp Speed program, which aims to deliver COVID-19 vaccines, therapeutics, and diagnostics.

Equipment and process optimization must be considered for scaling up these developmental technologies to commercial production.

Civica Rx plans redundant manufacturing capacity to relieve and prevent shortages of generic, sterile injectable drugs.

Risk levels should be considered when designing containment for pharmaceutical tableting equipment to enhance operator safety.

Whether refitting existing spaces or building new, the need for quick build times, flexibility, and production efficiency is driving trends in bio/pharma facility construction.

This article examines multi-tip tool technology for pharmaceutical tablet compression and the process control and validation issues that must be carefully evaluated to assess the potential for success.

Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes.

WuXi Vaccines, WuXi Biologics’ joint venture with Shanghai Hile Bio-technology, has signed a 20-year vaccine manufacturing contract with a global vaccine leader for $3 billion.

Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products.

Sartorius and the German Research Center for Artificial Intelligence have established a research laboratory for AI in the biopharmaceutical industry.

The expansion plans to build upon the company’s high potent drug manufacturing and development capabilities, including both clinical and commercial supply.

The expansion will enhance the company’s specialty drug product capabilities.

Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.

Trends affecting primary pharmaceutical packaging include the shift to more complex drug-device combination products.

Hovione Technology worked with Harro Höfliger on powder filling of blisters for the reusable Papillon DPI.

CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization.

The agency has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for reducing the risk of HIV-1 infection.

Pii is now responsible for commercial drug product production of fulvestrant, a breast cancer drug, while Sagent Pharmaceuticals, its abbreviated new drug application holder, will sell, market, and distribute the drug product in the United States.

EMA plans to issue new guidance, as US and European regulators respond to reports of nitrosamine contamination in H2 blockers, including Zantac, that contain rantidine.

The supply agreement comes after an eight-year collaboration between the companies.

At-line NIR measurements can replace a laboratory HPLC measurement for API content in oral solid-dosage drug manufacturing.

RINVOQ for the treatment of adults with moderately to severely active rheumatoid arthritis has been approved by FDA

Optima Pharma opened a new assembly hall, the CSPE Center, that will give the company space to build complete, multi-story pharmaceutical manufacturing facilities.

Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.