Manufacturing, Drug Products

The first generics of Lyrica have been approved by the FDA for neuropathic pain management and adjunctive therapy.

Catalent recently held a groundbreaking ceremony at its Bloomington, Indiana pharmaceutical fill/finish site.

The new cleanroom, designed and built by WHP, is part of ADC Bio’s new bioconjugation facility in the UK.

Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill and finish facility.

Today’s inspection systems catch tinier flaws, manage data, and increasingly rely on artificial intelligence to further boost performance.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

A groundbreaking ceremony was held in Rahway, NJ for Merck’s new FLEx facility that incorporates G-CON’s prefabricated cleanroom units.

A simple, one-part DPI aims to make inhalation drug treatment more accessible and affordable.

Wearable and smart devices allow user-friendly subcutaneous drug delivery.

The UK’s Centre for Process Innovation is collaborating with partners GSK and AstraZeneca to establish a continuous wet granulation manufacturing facility for small-scale development of oral solid-dosage pharmaceuticals.

Educational sessions on the INTERPHEX show floor will include a panel discussion on implementing continuous manufacturing.

3D printing offers a new design freedom for bio/pharmaceutical manufacturing: whether for “printing” a solid-dosage drug or for creating a piece of equipment for bio/pharmaceutical laboratories or manufacturing facilities.

In OSD continuous manufacturing, flexible batch sizes can optimize supply, but equipment and processing challenges are still being addressed.

It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.

Serialization-ready packing equipment and services to manage data assist companies with DSCSA compliance.

FDA guidance on quality considerations for continuous manufacturing should help advance implementation by providing clarity and giving companies more confidence to make investments in the new technology.

New technologies in the digital factory enhance quality, efficiency, and flexibility for bio/pharmaceutical manufacturing.

Containment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.

Eli Lilly and Company experts share the vision and the value of the digital plant for pharmaceutical manufacturing.

ACG Group highlighted its expanded footprint in Brazil through the launch of a new capsules manufacturing plant in Pouso Alegre-Minas Gerais.

In a partnership with Thermo Fisher Scientific Pharma Services, Pacira added a manufacturing suite in Swindon, UK, that doubles the company’s capacity by mirroring the company’s facility in San Diego, CA.

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.

Modular and podular laboratory and manufacturing allow rapid reconfiguration to support development of drugs for diverse patient populations.

Fette Compacting America has introduced the FEC20 Capsule Filling Machine, capable of producing up to 200,000 capsules per hour, to the North American market.

Tornado Spectral Systems, winner of the 2018 CPhI Excellence in Pharma Award for Analysis, Testing, and Quality Control, discusses real-time process measurement for biopharmaceutical and small-molecule drug manufacturing.

Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.

AqVida, winner of the 2018 CPhI Excellence in Pharma Award for manufacturing technology and equipment, identifies advantages of robotics compared to conventional automation in fill/finish operations.

Transdermal patch design, materials, and manufacturing variables, as well as drug formulation and interactions between the API and the adhesive, can affect adhesion and drug delivery.

Drug and adhesive formulation are crucial to the development of microneedle patches for pharmaceutical transdermal delivery systems.