APIs and Excipients

Assessing potential formulation and manufacturing issues in early development phases can improve a drug’s chances for success.

Drug companies must consider all factors impacting the cost of drugs, including high costs of early development stages.

Highly complex APIs developed to treat rare and orphan diseases present big technical questions for contract developers.

The performance of nanoparticles used as carriers in drug delivery is intimately linked to their physical properties. Nanoprecipitation is a common method for the preparation of drug-loaded polymer nanoparticles, but until recently, the reproducibility of the two primary dimensional descriptors-the average particle size and the breadth of the size distribution-has been a challenge due to the intrinsic variability of batch processes. Microfluidics-based flow techniques, however, reduce variation in drug-loaded polymer nanoparticle synthesis.

The authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

The study suggests that circumventing evolution in cell factories can enable the commercialization of new biobased chemicals to large-scale.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

Through its Janssen pharmaceutical companies, Johnson & Johnson, has partnered with Theravance to develop and commercialize a therapeutic for inflammatory bowel diseases.

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.

Cambrex invests in development and laboratory facilities and adds staff.

Avista Pharma's strengthens early phase drug development offerings with acquisition of Solid Form Solutions.

Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

The acquisition will strengthen Sanofi's R&D strategy and expands its franchise for rare blood disorders.

Corning will feature its 3D bioprinting technology and tools to support 3D cell culture at booth #1029 during the SLAS 2018 conference on Feb. 3-7, 2018 in San Diego, CA.

Comecar will provide cell culture equipment for biopharmaceutical company CO.DON AG's new production site in Leipzig, Germany.

Hovione has installed a new MG2 Tekna Precision Capsule filler at its Portugal site.

A ceremony was held at Cambrex’s Karlskoga facility to mark the commencement of a long-term manufacturing agreement with AstraZeneca for a key intermediate.

The acquisition, valued at EUR 520 million (US$631 million), would expand Takeda’s late-stage pipeline in gastroenterology and would extend an already existing collaboration between the two companies.

Graham Reynolds, vice-president and general manager, Global Biologics at West Pharmaceutical Services, Inc., shares insights on key considerations when developing a biologic drug product in a prefilled syringe.

The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig’s disease.

The companies aim to discover and develop locked nucleic acid oligonucleotides as orally available therapies for treating inflammatory bowel diseases.

The development of new packaging solutions that are fit for drugs of the future requires close collaboration between the pharmaceutical manufacturer and its packaging suppliers and machine vendors.

The Wilden Quattroflow QF10k size pump from PSG, a Dover company, has been designed to fill the gap between the existing QF4400/5050 and QF20k pump sizes.

FDA looks to achieve near-record level of new drug approvals following slowdown in 2016.

The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.