Manufacturing

Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.

Takeda inaugurated expanded capacity of solid-dosage drugs at its site in Oranienburg, Germany.

The European Medicines Agency approved Prezista (darunavir) made via a continuous manufacturing process at Janssen's facility in Puerto Rico.

A survey from The Pistoia Alliance found that just under a quarter (22%) of life-science companies are already using or experimenting with blockchain, but industry collaboration on security and storage standards is needed.

In a new research conducted by SEA Vision and Zenith Technologies, 28% of respondents identified technology selection as the biggest challenge as the industry prepares to meet serialization deadlines.

A loan from the European Investment Bank will give BiondVax resources for Phase III trials and a manufacturing facility for its universal flu vaccine.

The need for flexibility and higher quality are driving advances in parenteral manufacturing and fill/finish equipment.

The company added new products to its InfinityLab LC Series which will be showcased at HPLC 2017 in Prague.

The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.

A recent meeting emphasized the need for more guidance and flexibility from regulators, as well as harmonization, standards and equipment interoperability.

Aptar now manufactures its child-resistant pump, designed to meet US CPC requirements, at its facility in Congers, New York.

Werum’s Plug & Produce solution eases connection with smart equipment and control systems.

At an industry seminar hosted by Leistritz Extrusion, experts explained the use of extrusion equipment to mix polymeric excipients with APIs for solubility enhancement and for multifunctional and specialty dosage forms, including implants.

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

USP describes analytical and microbiology testing required for different types of pharmaceutical water.

Lubrizol Invests $60 Million to Expand Particle Sciences and Other Facilities in 2017.

Takeda will build a new production facility at its existing Grange Castle site in Ireland.

Acasti Pharma and CDMO CordenPharma designed and implemented a continuous process for purifying raw krill oil for production of omega-3 phospholipid.

The author shares his opinion on the challenges presented by the Internet of Things and what companies need to consider when choosing suitable architectures to manage serialization data.

Cambrex announces expansions of its North Carolina API pilot plant and Kalskoga, Sweden large-scale manufacturing facility.

The new UPS facility in Columbia will serve the growing pharmaceutical, biopharma, and medical device industry in Latin America.

As cost pressures mount as a result of multiple biologics being developed for the same indication, manufacturers can harness process efficiencies to maintain the value of legacy products.

The author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.

Serialization and complementary authentication technologies are needed in order to meet DSCSA and FMD regulations.

The past several months have seen new product releases and updates made to already available laboratory equipment.

Modern air jet milling can be used to investigate the feasibility of micronization as a solubilization approach in formulation development.

Follow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device.

The company recalled the tablets due to a packaging error.

Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.

Single-use systems demonstrate advantages over stainless-steel systems for biopharmaceutical manufacturing facilities.