Manufacturing, Drug Products

Advances in equipment, instrument, and control systems are enabling online monitoring of continuous API manufacturing.

Although technical paths for continuous solid-dosage manufacturing have been laid out and equipment and control systems have been developed, industry is slow to move forward.

Advances in process analytical technology have been achieved, but significant challenges remain.

Conferences focused on continuous solid-dosage manufacturing aim to spread the word about technical capabilities and alleviate perceptions of regulatory uncertainty.

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

Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity.

Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.

Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.

Advances in materials and equipment for pharmaceutical blister packaging protect quality and enhance shelf life.

FDA and BARDA awarded a contract to Continuus Pharmaceuticals to develop an end-to-end continuous manufacturing process for solid-dosage drugs.

Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.

This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.

Primary packaging and manufacturing technologies minimize product/package interaction, protect quality, support safe travel through the supply chain, and enhance performance at point of use.

This key bioprocessing segment is expecting continued growth

Visual inspection of parenteral vials is the first step in a root cause investigation.

The authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.

PharmTech’s 2016 survey shows general satisfaction with existing solid-dose and parenteral manufacturing equipment, and slow adoption of continuous manufacturing processes.

Innovations protect product quality, improve productivity, enhance sustainability, and simplify usage for patients and caregivers.

Preheating pinch valves prevents drift in the volume of liquid dispensed.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

A US government report on advanced manufacturing promotes continuous manufacturing of pharmaceuticals, which has had recent commercial success but faces challenges for widespread adoption.

Intact enables aseptic filling in non-classified environments, maintains sterility throughout the process, and reduces costs, timelines, and contamination risks.

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.

FDA approved an update in the manufacturing of Prezista (darunavir) using a continuous manufacturing line at Janssen Supply Chain’s facility in Puerto Rico.

Science-based software and testing services expedite the material selection process and ensure blister packs deliver adequate barrier protection for solid-dosage forms without over-packaging.