Formulation and Drug Delivery

To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.

Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.

Glass vials have come a long way from mere commodities and are now considered an integral part of final drug product.

Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.

Formulators of parenteral drugs must be cautious of specific considerations and challenges that arise during development and manufacture.

As patient-centered therapies and clinical trials become more important, innovation is providing more control and transparency in the way that pharmaceuticals are delivered.

Industry experts discuss the role of gene-editing techniques in regenerative medicine and cell-line development.

Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.

Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.

Researchers in China are playing a role in advancing gene therapy development.

Neuraxpharm Group has announced it is launching its first products in the United Kingdom.

Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.

Cure Pharmaceutical secured a patent that lets the company load higher drug amounts to its proprietary drug delivery system, CUREfilm.

An agreement with Sanofi gives Catalent access to commercial spray drying facility in Haverhill, UK.

The Native Antigen Company has revealed its appointment of Biozol and Shanghai Bioleaf as its distributors in Germany, Switzerland, Austria, and China

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.

FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.

FDA and USP take sides in debate on biologic drug standards.

The Wellcome Global Monitor has demonstrated an overall positive trust in science but some concerns still remain on attitudes on vaccines.

Several trends are driving change in oral solid‑dosage forms and giving rise to the requirement of ‘fit-for-purpose’ excipients.

Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.

More than 30 lots of losartan drug products have been recalled due to contaminated API manufactured by Hetero Labs.

Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.