Contract Manufacturing, Biopharmaceutical Production

There are significant differences between small molecules and biologics fill/finish capacity.

Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.

Experts from Baxter BioPharma Solutions provided the following commentary on trends in bio/pharmaceutical development outsourcing.

Representatives of contract service organizations that develop biologic-based drugs discussed technology trends such as high-throughput screening and single-use systems.

Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.

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

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.

Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

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

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

A UC Berkeley survey provides insight into biopharma's risk concerns and strategies.

Innovation resulting in improved productivity continues unabated and is a primary driver for many of the current biopharmaceutical trends.

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

In a quick-fire interview, Dr Stephen Taylor, Vice President & Commercial Director at Fujifilm Diosynth Biotechnologies, looks at some of the challenges facing biologics outsourcing.

The author provides an overview of QbD implmentation for biopharmaceuticals.

More crucial biomanufacturing operations are expected to be outsourced.

Last week, Lonza (Basel) agreed to support the ongoing development of GlaxoSmithKline?s (GSK, London) biopharmaceutical pipeline by supplying manufacturing capacity for five early-stage monoclonal antibodies.

Every biopharmaceutical is unique and products are defined as much by their manufacturing process as their analytical characterisation. Because of this, the development of biologics has many inherent complexities over small molecule projects.

Merck & Co. Acquires Avecia Biologics; Ambrilia Biopharma Closes Manufacturing Facility; And More.

Company and People Notes: Also, Pfizer and Protalix enter agreement; Watson acquires Arrow Group; and more.

A joint biopharmaceutical manufacturing facility in India by Kenwell and Boehringer Ingelheim ushers in new era.

Kemwell (Bangalore, Karnataka, India) plans to build a new biopharmaceutical manufacturing plant in Bangalore, India, in a strategic collaboration with Boehringer Ingelheim (BI, Ingelheim, Germany), according to a Kemwell press release.

Strong growth in biopharmaceuticals bodes well for contract manufacturing, but the perils and the promises of pipelines remain.

Biopharmaceuticals are the most rapidly growing segment of the pharmaceuticals market. Developing and marketing biopharmaceuticals are huge roles in almost every major pharmaceutical company's strategy. However, they are extremely complex molecules and are highly sensitive to the manufacturing processes used to produce them. These processes require exquisite control of living production systems, making, without a doubt, biopharmaceuticals one of the most challenging products of any type to manufacture.

A surge in capacity in contract microbial and mammalian cell-culture is underway to meet rising production needs for biopharmaceuticals.

The authors analyze the supply–demand trends for contract biologics manufacturing and the strategies of pharmaceutical and biotechnology companies and their suppliers in the value chain.

One of the biggest barriers research and academic institutions face is the ability to get discoveries made in the lab into clinical testing. Because only small amounts of drugs are used in these early studies, they represent fewer potential risks for people in these trials.

Is the lack of finance necessarily spelling doom for the European biotech industry?

A CMO in Singapore manufacturing commercial biopharmaceuticals is the result of a partnership between two biopharmaceutical companies.