Dosage Forms

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.

Assessing potential formulation and manufacturing issues in early development phases can improve a drug’s chances for success.

Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.

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.

Integration of formulation development, real-time adaptive GMP manufacturing, and clinical testing using a consumer preference panel can save time and cost in performing taste-masking assessments.

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

Colorcon's Opadry EZ provides superior slip and significantly reduces the probability of the tablet sticking to the throat or esophagus.

Fluarix Tetra has been approved for use in children aged six months and above.

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.

Cambrex invests in development and laboratory facilities and adds staff.

A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics.

This article describes how to improve the regulatory journey from classification to market clearance for sponsors of medical device combination products.

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

Growth is expected for the generic drugs and biosimilars sectors, driven by cost pressures on healthcare systems.

Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.

The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.

The company completed its oral solid dose production facility in Suzhou, China.

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

The companies will collaborate on the development of vaccines to expand GeoVax’s cancer immunotherapy program.

The agency published draft guidance on good practices for submitting abbreviated new drug applications.

The development of new packaging solutions that are fit for drugs of the future requires close collaboration between the pharmaceutical manufacturer and its packaging suppliers and machine vendors.

Measurements by a drone-based online pressure monitoring system help identify weak points in the filling line, enabling the process to be optimized.

Glass and plastic are well established primary packaging materials for the pharmaceutical industry but they both have their advantages and disadvantages.

The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.