Formulation and Drug Delivery

Study provides first substantive reference data on key quality attributes of empty capsules

Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009.

Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.

New International Council on Biotechnology Associations advocates biotechnology growth.

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.

PolySciTech's new launch, SpinSwiper, has the potential to speed up microparticle production.

Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

Industry experts share their perspectives on key advances in controlled-release drug delivery and future innovations in this arena.

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

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Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.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

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.

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.