Biologic Drugs

Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.

Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.

The author presents best practices for extractables and leachables.

GE Healthcare's partnerships with iBio and Brazil's Bio-Manguinhos/Fiocruz for a new plant-based multipurpose biopharmaceutical and vaccine manufacturing facility move plant-based protein production to the next level.

Since its inception in 2011, Fujifilm Diosynth Biotechnologies has added capabilities and single-use production capacity for mammalian-derived product manufacturing, upgraded development and pilot-scale microbial laboratories, and installed advanced analytical instrumentation.

PSL has developed a microsphere refiner for microsphere formulation, from small scale processes to commercial production.

EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

Facility will use mammalian cell-culture technology and be ready for operations by 2016.

The authors report on the range and distribution of grow-out times for biological indicators exposed to sublethal sterilization processes.

Advances in monoclonal antibody separation technologies are largely driven by the need to increase efficiencies and reduce cost.

Applications of ZFN technology in biopharmaceutical cell-line engineering.

Despite overall manufacturing rationalization in the pharmaceutical/biopharmaceutical industry, the large pharmaceutical companies continue to invest in biologic-based manufacturing. The author provides an update in recent investment activity among the pharmaceutical majors in biologic-drug substance, vaccine, and parenteral drug manufacturing.

With high productivity achieved, makers of cell-culture media are working to optimize product quality through better understanding and control of raw materials and production processes.

Teva and Lonza have announced that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars.

Sound policies are needed to govern the substitution of interchangeable biologics.

A Q&A with Tony Hitchcock, head of manufacturing at Cobra Biologics.

Matthieu Egloff, product director with ATMI LifeSciences, discusses the need for larger, special reactors that can provide the necessary conditions for the production of fragile cells on a larger scale.

Roche and BioLamina have entered into a research and development agreement to jointly develop new cell culture systems for various applications, including stem cell research. The collaboration will assess laminin-based in-vitro cell culture matrices that can offer physiological microenvironments for living cells.

Companies risk drowning in alphabet soup if the latest three-letter acronym improvement strategy isn't clearly linked to business strategy.

Kevin Ott, executive director of the Bio-Process Systems Alliance, discusses the latest trends and issues surrounding single-use technologies and the role of his association.

Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.

The share of biologic-based drugs in the global pharmaceutical market is on the rise.

Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.

Policymakers must balance fundamental issues involving access to medicines and pricing.

The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).

The long-awaited patent cliff that has loomed in the pharmaceutical industry for years has arrived in earnest in 2012, with more than $40 billion in 2011 brand sales facing loss of exclusivity.

There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.

A look at elastomer changeout times shows how industry knowledge improves operations and cost.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.