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China’s Emergence in Global Biopharma Manufacturing: Trends in the Chinese Biopharma Industry

This four-part educational series, sponsored by BioProcess International and BioPlan Associates, Inc., highlights key trends emerging in China biopharmaceuticals, using select content BioPlan Associates’ 2018 2nd edition report, Advances in Biopharmaceutical Technology in China, 2nd Ed. The quarterly series, each consisting of articles, an e-book, 40-min webcast, and live presentation at select BPI Events cover China’s Emergence in Global Biopharma Manufacturing: Trends in Chinese Biopharma Industry. The projects include an Overview, Developments in Biologics, Biosimilars, and Global Expansion. The series…

MilliporeSigma plans to ramp up filtration manufacture in NH

MilliporeSigma intends to add an additional 38,500 square feet of manufacturing space at its site in New Hampshire to support demand for filtration devices. The bioprocessing business unit of Germany’s Merck KGaA, MilliporeSigma, has revealed it is planning to expand a site in Jaffrey, New Hampshire that makes filtration equipment for the life sciences industry. “To meet the future demands of the bioprocessing market, we are in the approval process to expand the facility with additional cleanroom and lab space…

Analytical Challenges: Characterization of Oligonucleotide Therapeutics

Recent approvals of oligonucleotide therapeutics are a clear signal for optimism for this product class. This is supported by the strength of the current pipeline which has over 180 active oligonucleotide clinical programs in various phases of development. Improvements in analytical technology and know-how have played a key role in enabling suitable characterization and quality control strategies to overcome the difficulties associated with testing these complex molecules. Despite the lack of dedicated regulatory guidelines related to characterization or quality control,…

China Looks Inward and Outward: Investments in US and EU Biopharmaceutical Companies Are on the Rise

The growth momentum of China’s biopharmaceutical industry continues, with the China Industry Research Institute projecting that the country’s biological therapeutics market could reach 300 billion Chinese yuan (~US$50 billion) in 2019. According to the second edition of our report on advances in Chinese biopharmaceutical technology, this robust growth is boosted by continuing investment into the sector (1). A clear strategic indicator of the country’s intentions in biotherapeutics and biologics has been government investment in bioindustrial hubs, which by next year…

The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production –
Part 2: Regulatory Overview

The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. Corporate members include plasticequipment suppliers, service providers, and users in the biopharmaceutical industry who share this mission. A key focus of BPSA’s core activities is to educate its members and others through sharing of information and development of best practice guides that help suppliers, users, and…

Opportunities for Modern Robotics in Biologics Manufacturing

It should come as no surprise to anyone familiar with biomanufacturing that current designs of bioprocess facilities as well as associated manufacturing spaces and support operations require excessive amounts of manual labor and manual interventions that lead to high labor costs and, consequently, total cost to supply. From receipt of raw materials to process execution and performance review, resolution of quality issues, and product shipping, no industry devotes a greater percentage of operating costs (or cost of goods sold, CoGS)…

Cell and Gene Therapy Data Management: Solutions to Address Complex Challenges

At the Phacilitate Leaders World and World Stem Cell Summit 2019, held 22–25 January, Steve Goodman (head of drug product manufacturing at bluebird bio) and Robert Di Scipio (CEO of Skyland Analytics) shared the podium to address what the product and process data-management ecosystem looks like for cell and gene therapy (CGT) development and manufacturing. A starting point for their presentation was that CGT development presents significant data challenges: capturing and analyzing product development and manufacturing data, tracking the collection,…

Monoclonal Antibodies: Beyond the Platform in Manufacturing

The vast majority of monoclonal antibody (MAb) production processes are based on fed-batch Chinese hamster ovary (CHO) cell culture and protein A affinity column chromatography capture. Increasing cost-consciousness — among innovator companies as well as biosimilar makers — has many companies looking “beyond the platform” for less expensive alternatives that may provide better results. Here the BPI editors review some state-of-the-art alternatives in upstream and downstream MAb drug substance bioprocessing as well as drug-product manufacturing. The current “gold standard” platform…