Dosage Forms

Despite the advantages intensified processes can offer developers, there are still some obstacles to overcome before broader application of new technologies will be implemented.

Alternative approaches to freeze-drying are gaining popularity and will help to overcome some of the challenges associated with conventional lyophilization.

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.

This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.

EnteroBiotix is harnessing the power of the microbiome to target an array of diseases.

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

Quotient Sciences’ facility expansion is designed to increase support for fully integrated drug development programs.

In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.

Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.

Efforts to optimize the delivery of sensitive biotherapeutics continue to evolve.

This new pioneering phase of mRNA is loaded with potential, but also obstacles and false dawns.

Materials enhance sustainability and efficiency.

Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?

Manufacturers must consider key components of manufacturing solid versus semi-solid drugs to create a successful end product.

TreeFrog Therapeutics is leaping ahead in cell therapies through resources such as new technologies and investor partnerships.

The latest report from Clarivate has been published, highlighting 15 potential blockbusters to watch out for in 2023, the majority of which are personalized medicines.

One can improve method precision and productivity by replacing one step in sample preparation with an automated approach.

Unique solutions are required to protect inherently unstable messenger RNA.

Unique dosage forms, personalized medicine, and flexible manufacturing are possible with 3DP.

SPX-001, a respiratory drug candidate, will be submitted through a combined Clinical Trial and Ethics Committee application for further advancement in the clinical stages.

Advancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.

This article introduces a control chart technique using F statistic for continued process verification of oral solid dosage forms.

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

Creating building blocks for good manufacturing practices is essential.

Moderna is suing Pfizer and BioNTech for allegedly infringing on patents the company filed from 2010 to 2016.

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

Biosimilar data analysis must demonstrate a correlation between structure and function.