11.28.22 -- Outsourcing History And Core Values

This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

In its commitment to the delivery of novel molecular formats, Lonza has designed a CMC strategy for bispecific molecules that enables delivery of a data package for IND submission within 13 months.

Engaging a partner with the expertise and protocols for a comprehensive tech transfer is key to mitigating risks, such as unsatisfactory yields, unforeseen materials shortages, or unoptimized batch sizes.

Conceived by the EPA more than 30 years ago, “green chemistry” prompts solutions to real-world environmental problems resulting from industrial processes, emissions, and waste.

Environmental considerations in pharmaceutical manufacturing strategies have become increasingly important in the face of additional calls to address pollution and sustainability practices globally.

Together, nuclear magnetic resonance (NMR) and MS analysis can definitively identify reference standards, active pharmaceutical ingredients (APIs), or final drug product composition.

A new manufacturing platform offers significant benefits for clinical production of lentiviral vectors and further enables support for the continuing global demand for high-quality gene and cell therapy products.

Once you've identified a CMO partner, how do you ensure success? The secret: planning as early as possible — while your product is still in preclinical or clinical development.

A strategic partner should seek innovation that improves your compound or product’s value. Pfizer CentreOne’s Tom Wilson shares tips for picking the perfect API partner.

Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.

We evaluated and compared HyClone characterized FBS originating from the United States, New Zealand, and Australia for cell culture and production performance.

Any changes to the equipment and processes used to produce a semi-solid dosage form may affect the physicochemical characteristics, bioavailability, and sensory qualities of the final product.

Nasal spray administration of medicine offers advantages over oral and intravenous (IV) delivery. Experts discuss the advantages and opportunities of adopting unit- and bi-dose nasal delivery technology.

Review tips and considerations for robust viral vector analytical characterization, including strategies to overcome challenges in assessing impurities and defining critical quality attributes (CQAs).

A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.