Manufacturing

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

Anthony Qu, PhD, vice president of Scientific Affairs at Halo Pharma, will give a presentation on fixed-dose combination products, drug products containing multiple active ingredients, as an effective approach for simplified dosing at CPhI North America on Wednesday, April 25, 2018 in Philadelphia, PA.

The contract manufacturing organization’s facility in Boulder, CO, has passed general inspection from FDA.

On Tuesday, April 24, 2018, Evan Boswell, senior principal scientist at Pfizer CentreOne Contract Manufacturing, Pfizer CentreOne will give a presentation on scaling up the manufacturing process of active pharmaceutical ingredients at CPhI North America in Philadelphia, PA.

Colorcon Inc. and Applied DNA signed a supply agreement granting Colorcon exclusive right to use Applied DNA’s SigNature molecular tags in film coatings for solid oral dosage forms, and non-exclusive rights to use it in inks and colorants for SOD pharmaceuticals.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

The contract development and manufacturing organization announced the addition of a new building complex that will house its headquarters in Bothell, WA.

Fujifilm acquires cell culture media companies Irvine Scientific Sales Company and IS Japan.

The active pharmaceutical ingredient and excipient provider has expanded its parenteral ingredient manufacturing capacity and lab services.

Designing a mechanical integrity program using existing best practices can help pharmaceutical manufacturers comply with OSHA’s standard for process safety management.

How warehouse execution systems can help in case of a drug recall.

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.

Particle engineering using jet milling or spray drying can be used to obtain appropriate particle characteristics for inhalation drug products.

Keystone Folding Box has added a new line of secondary packaging systems for injectable pharmaceutical products.

Ross Systems and Controls (SysCon) touchscreen purged panels have been certified under the standards of Underwriters Laboratories’ (UL)-698A Code and the National Fire Protection Association’s (NFPA)-496 Code.

CMOs/CDMOs that are easy to work with, have demonstrated performance track records, and plan for the future are preferred.

Nik Leist’s keynote address will explore the manufacturing of digital medicines at the CPhI North America 2018 conference in Philadelphia, PA, on Wednesday, April 25, 2018.

Research suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.

Taking vendor product data at face value puts pharmaceutical manufacturers and their supply chain partners at risk.

Equipment and product innovations improve pharmaceutical manufacturing tasks.

The new premises have been built-to-spec to offer efficient, high quality, and environmentally friendly service to customers.

The company’s close communication with customers has enabled it to bring advanced pipetting products to market.