Formulation and Drug Delivery

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

GSK reports 5-year vaccine price freeze for countries graduating from GAVI Alliance.

New manufacturing capacity at the Le Mans, France facility is being used to scale up antibody drug conjugates.

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

A global contract manufacturer of biologics discusses the increasing impact of health-based exposure limits in assessing cross-contamination risks.

What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

Catalent's Advasept platform uses blow-fill-seal technology to aseptically manufacture, fill, and seal a polymeric primary container for injectable drugs.

Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.

Once an afterthought, packaging has now become an essential component of biopharmaceutical product development and marketing.

Zero-order release of a freely water-soluble active drug can be obtained using release-controlling polymers.

With the rising threat of antibiotic resistance and a diminishing R&D pipeline for novel drugs, Europe must step up its game to address this growing problem.

Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals.

New formulations and expanded vaccine production are encouraged.

Gallus BioPharmaceuticals enters a cell line optimization and manufacturing agreement with Omni Bio Pharmaceutical.

TAP Biosystems announced that Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.

Experts share insights on how product appearance such as size, shape, color, and imprint can make a difference in reducing medication errors.

Lifecycle management opportunities are impacting the development of controlled-release technologies for solid-dosage drugs.

The author examines the effect of compaction force, gap width, and sieve setup on granule size.

FDA develops an assay that could speed the release of pandemic influenza vaccines.

Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.

Encapsulation technologies for solubility/bioavailability enhancement, controlled release, and formulation of drug combinations and patient-friendly dosage forms.

Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses eClinical supply-chain management.

Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.

Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.