Dosage Forms

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

With the right excipients, formulators can control when, where, and how an API is released.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.

Recipharm adds inhalation drug manufacturing capacity with the acquisition of Sanofi’s Holmes Chapel, UK site.

Cambrex expands its generic API research and development capabilities at its Milan, Italy site.

MilliporeSigma targets emerging biotechs with US development center and global grants.

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

Bosch Packaging Technology will introduce its newest R&D device for continuous oral solid dosage production at Achema 2018.

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.

Cambrex Corporation has announced facility, equipment, and instrument upgrades at its High Point, NC facility and updated progress on expansions in Cedar City, IA.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.

The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.

Choice of carrier can have a significant impact on the capsule filling process as well as the performance of the DPI formulation.

Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.

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

Public health authorities and the biomedical research community are seeking new strategies to address global health threats.

A skilled workforce is needed to deliver on technology’s promising medical advances.

Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.

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 agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.

Proteus Digital Health is collaborating on a pipeline of digital, oral solid-dosage drugs for various therapies, including cardiovascular and oncology drugs, based on its first NDA, which used ingestible sensors in an antipsychotic treatment.

The new platform is expected to speed up cell line development.

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

INTERPHEX presents advances in pharmaceutical container filling, robotic handling, and serialization.