Drug Development

Articles

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

FDA Develops Alternative Assay to Increase Availability of Influenza Vaccines

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

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

Appropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs

Joan FitzPatrick is director of Business Development and Scientific Affairs at Freund Pharmatec, Unit 1, IDA Business & Technology Park, Srah, Tullamore, Co. Offaly, Ireland, email: joan.fitzpatrick@freundpharmatec.com.

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

Drug Encapsulation for Patient-Centric Dosing

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

The Benefits of eClinical Systems in Supply-Chain Management

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

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.

Navigating the Regulatory Landscape of Combination Products

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

Increased Efficiency Key to Competitiveness in Downstream Bioprocessing

Anil Kane from Patheon spoke to Pharmaceutical Technology about the challenges in the development of FDCs and discussed how to integrate quality-by-design (QbD) in the manufacturing process of FDCs.

Tackling challenges in the development of fixed-dose combinations

Advanced drug delivery technologies can increase efficacy and safety, extend patent lives, and provide competitive differentiation for biopharmaceuticals.

Drug Delivery Technologies Provide Growth Opportunities for Biopharmaceuticals

Pfizer intends to submit a biologics license application for its investigational Meningococcal B vaccine candidate, Bivalent rlp2086, to FDA by mid-2014.

Pfizer Receives Breakthrough Therapy Designation for Meningococcal B Vaccine Candidate

Adocia has reported positive results for the first clinical trial of its combination insulin formulation of fast- and long-acting insulin in patients with type I diabetes. Results showed that BioChaperone Combo provided both short- and long-term control of blood glucose in type I diabetic patients, with a faster onset and a longer duration of action.

Formulation and Drug Delivery