Manufacturing, Biologic Drugs

Samsung BioLogics begins construction on their third facility in Songdo, Korea.

Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.

FDA confirmed quality focus while Congress moved to bolster biomedical innovation.

Biotech boom, niche markets, smaller batch sizes and high potency manufacturing are among the key trends shaping the pharmaceutical industry of the 21st century, according to Christian Treitel from Bosch Packaging Technology.

South Africa’s Biovac Institute, which develops and produces vaccines for the country, launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.

While biologics development grabs investor interest, small-molecule APIs still hold two-thirds of the drug-development pipeline.

According to a third-quarter earnings report, Pfizer’s vaccine business contributed nearly 14% to its total revenue.

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

The PDA report discusses qualification and operational handling of passive thermal protection systems.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss performing investigations of biological products.

Despite emergence of biologics, small-molecule APIs benefit from industry growth.

There is growing interest in the development of liquid formulations in prefilled syringes and autoinjectors, which offer convenience and ease of administration in a home setting.

Industry Expert Q&A with Robin M. Silva, Partner, Morgan, Lewis, and Bockius LLP

The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

A study now underway on vaccine manufacturing examines the effects of focusing on consistency during manufacturing, instead of post-production testing.

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

Despite the buzz about biologic-based drugs, small molecule-based drugs are still the mainstay treatment.

The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

Medicago's new production facility will make plant-based vaccines and therapeutics.

AstraZeneca announces that it will invest $285 million in a new manufacturing facility in Sweden.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Catalent’s Zydis technology will be used to develop thermo-stable and cold-chain independent vaccines.

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.