Formulation and Drug Delivery

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.

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

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

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.

Novartis has launched the prefilled syringe formulation of Lucentis (ranibizumab) in Germany, with other markets to follow throughout 2014. The prefilled syringe formulation has been specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.

The Pediatric Praziquantel Consortium has been awarded a research grant from the Japanese Global Health Innovative Technology (GHIT) Fund. The grant will be used to fund the Consortium's clinical development program of a newly developed praziquantel pediatric formulation targeted for use in very young children, including infants and toddlers, infected with schistosomiasis.

To gain insights into the current trends of the biotechnology sector in the United Kingdom, Pharmaceutical Technology Europe spoke with Steve Bates, chief executive officer of the BioIndustry Association (BIA), the trade association for biotech companies in the UK.

HHS plan makes progress in ensuring availability of safe vaccines.

Schott's 20-mL TopPac prefillable polymer syringe simplifies the infusion-therapy preparation process.

Despite the progress made in nanomedicine development, there are several issues that remain unresolved. Raj Bawa, PhD, provides insight.

Accelerated testing and production create challenges in documenting product quality.

Nanomedicines can offer promising benefits in the diagnosis and treatment of diseases but there are still concerns about the safety and quality of these therapeutics partly because of the lack of clear regulatory guidance. Scott McNeil, PhD, director of the Nanotechnology Characterization Laboratory (NCL), spoke with Pharmaceutical Technology about nanomedicine characterization.

Advances in nanomedicine have provided several potential candidates for safe and effective delivery of siRNA.

With nanomedicines on the rise, a new class of non-biological complex drugs (NBCDs), which include nanosimilars, has emerged. As drug regulators are faced with the challenge of defining a framework to ensure the safe introduction of the follow-on nano-therapeutics, Stefan Muhlebach explains why NBCDs cannot be assessed using the standard generic or biosimilar approaches.

A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.

Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.

New methods of encapsulation and filtering address scale-up challenges.

EMA releases an update on its flu vaccine guidance.

Mylan Pharmaceuticals launches Hertraz, the world's first trastuzumab biosimilar in India.

BioOutsource will open a new Biosimilar Center of Excellence in Scotland.

FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.

CMOs may find opportunities in alternative expression services.

Experts discuss factors affecting drug delivery to the lungs and key considerations when developing inhalation formulations.

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

A changing biopharmaceutical industry is going beyond typically outsourced activities and is using CMOs for more challenging processes. Review the top 10 outsourcing trends.

PharmaCell enters an agreement purchase TiGenix therapy production facility.

With numerous biologics set to come off patent soon and the percentage of new therapeutics based on biomolecules growing, demand for contract manufacturing in the biopharma space is heating up.

NCI launches trial to assess the utility of genetic sequencing to improve patient outcomes.

Novozymes Biopharma has released new study data on extending the serum half-life of albumin in vivo.

Products enable testing in accordance with methods described in new USP monograph.