Manufacturing, Drug Products

Under the contract, AMRI will focus on the development and manufacture of APIs and drug product for Phase I clinical studies.

The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.

PDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration.

The UK’s University of Sheffield opened a new chemical engineering teaching plant for continuous oral solid-dosage pharmaceuticals using GEA’s multipurpose platform.

Glatt Ingenieurtechnik has added compact continuous agglomeration equipment and new control systems to its "modular plant engineering" portfolio.

As more continuous processes move toward commercialization, users and equipment vendors are working to speed changeovers and address other needs.

The tablet tooling manufacturer will showcase its products and services, which include an online training package and a tool management system for proactive monitoring of tooling rotations, inventory, and maintenance.

L.B. Bohle’s QbCon 1 laboratory-scale, continuous twin-screw granulator and dryer offers fully continuous drying for R&D in continuous solid-dosage manufacturing.

Romaco will display the IHD series for processing hot melt coatings at Achema 2018.

Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

The pharmaceutical industry is adopting Industry 4.0 and emerging technologies to improve product quality and manufacturing efficiency.

Pharma 4.0 envisions highly efficient automated processes, which could be continuous, batch, or a hybrid of these, driven by an integrated manufacturing control strategy.

Process analytical technology and advanced process control strategies can be applied to either batch or continuous manufacturing of solid-dosage drugs.

Puncture and aerosolization tests measure the effectiveness of hard-shell capsules used in dry powder inhalers (DPIs) for inhaled drug products.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.

Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.

Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully.

FDA approves Vertex's cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.

Ompi EZ-fill vials and Daikyo Seiko PLASCAP press-fit closures are a confirmed product set for use with Vanrx Pharmasystems' Aseptic Filling Workcells.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.

A systematic framework and software are needed to implement material traceability in continuous pharmaceutical tablet manufacturing.

New technologies, such as NIR and Raman, enable online measurements of blending and content uniformity in the production of solid dosage forms.

Hovione has installed a new MG2 Tekna Precision Capsule filler at its Portugal site.

The company is seeking approval from FDA for use of the drug, migalastat, to treat Fabry disease in patients who have amenable mutations.

The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.

The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.

Optimizing water and HVAC systems can reduce resource use in all pharma facilities, and, for biopharma manufacturing, the supply chain of consumables should be evaluated.

A QbD approach can address manufacturing complexities in transdermal patch manufacturing.