Upstream & Downstream Processing Archives - Page 31 of 38 - BioProcess InternationalBioProcess International

Rentschler $34m Austrian plant to feed freeze-drying capacity demand

Rentschler Fill Solutions has inaugurated a €30 million ($34 million) fill & finish facility in Austria. The site will produce Mepsevii (vestronidase alfa) drug product for Ultragenyx Pharmaceutical. Construction of the facility began in July 2016, and the plant received GMP approval in August this year. But today (Friday) the contract development and manufacturing organization (CDMO) officially inaugurated the facility in Rankweil, Austria. The clinical and commercial plant forms part of Rentschler Biotechnologie’s strategic alliance with Leukocare, which aims to…

NIIMBL and BPOG publish roadmaps for ADCs, vaccines and gene therapies

by BPI Staff

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), in collaboration with the BioPhorum Operations Group (BPOG), has published a series of technology roadmaps for the biopharma industry. The roadmaps cover manufacturing issues surrounding gene therapies, vaccines, antibody-drug conjugates (ADCs) and bi-specific antibodies, and are based on insight from biomanufacturers, equipment makers, suppliers, academic institutions, non-profits, and federal agencies. They are intended to provide a clear vision of innovation for biopharmaceutical manufacturing processes and platforms and address technology needs and…

Staffing shortage leaving blockbuster biologics undeveloped, says expert

by Dan Stanton

A shortage of bioprocess talent drives high salaries and hinders drug development, says BioPlan Associate’s Eric Langer. As biologics increasingly dominate pipelines, biomanufacturers look to traditional pharma to plug the staffing gaps. Speaking last month at the BIOLive event at CPhI Worldwide in Madrid, Eric Langer, president and managing partner at BioPlan Associates, said hiring is one of the biggest problems facing the biopharma industry. “It is painful [to the biopharma hiring managers] that 40% of the biopharma industry cannot hire…

Collaboration looks to crystallization as alternative to multi-step chromatography

by Dan Stanton

A European Union funded project to improve downstream processing is on track for completion by October 2020, says collaborator Fujifilm Diosynth Biotechnologies. The AMECRYS research project, funded through a €3.5 million ($4 million) grant through the European Union’s Horizon 2020 program, has brought together industry with government and academic institutes to develop alternatives to multi-step batch chromatography platforms. One of the collaborators is biologics contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies, which has reached a milestone in the…

GE to use Wego to make single-use products in China, for China

by Dan Stanton

Wego Pharmaceutical Co. will manufacture single-use bioprocessing consumables on behalf of GE Healthcare from its facility in Weihai, China. The partnership with China’s Wego, financial details of which have not been divulged, will decrease product delivery times of GE Healthcare’s single-use bioprocessing products for Chinese biopharmaceutical companies, the firm says. “This collaboration helps local Chinese biomanufacturers focus on bringing much needed therapeutics to Chinese patients,” Olivier Loeillot, general manager of BioProcess at GE Healthcare Life Sciences, told BioProcess Insider. “Local…

Catalent pumping $200m into biomanufacturing expansions

by Dan Stanton

Catalent plans to double fill/finish capacity at its Bloomington site and add a fourth and fifth train at its Madison drug substance facility. During its fourth quarter FY2018 call, contract development and manufacturing organization (CDMO) Catalent said it was eyeing up a fourth and fifth biomanufacturing train at its Madison, Wisconsin plant. And during its Q1 FY2019 investor call, CEO John Chiminski confirmed the board has approved both the expansion in Madison and a doubling of capacity at its Bloomington,…

Future market needs driving vendor innovation, says MilliporeSigma

by Dan Stanton

MilliporeSigma has brought together its next-generation technologies, both acquired and developed in-house, under the formalized BioContiuum platform. The offering looks to obtain incremental process benefits now, with a mind to the continuous process of the future, the firm says. MilliporeSigma’s BioContinuum platform, its self-described holistic approach to next-generation bioprocessing, is being launched at the AAPS event in Washington DC next week. Ahead of the event, Andrew Bulpin, head of Process Solutions at the vendor, told BioProcess Insider how the offering…

High Octane: Lonza buys 80% of ‘game-changing’ cell therapy tech partner

by Dan Stanton

Lonza has acquired a controlling stake in its partner Octane Biotech and will incorporate the closed and automated Cocoon processing tech into its autologous cell therapy offering. Contract development and manufacturing organization (CDMO) Lonza has collaborated with Octane Biotech for the past three years to develop the Cocoon manufacturing system. But this week, the Swiss CDMO purchased additional equity to hold a controlling stake of 80% in the firm, with an option for outright ownership. “Owning a controlling stake ensures…

Thermo Fisher services biz up 28% as Patheon enters the mix

by Dan Stanton

Construction is underway at the ‘largest outsourced single-use site in North America’ says Thermo Fisher, a year after acquiring CDMO Patheon. In April 2018, Thermo Fisher Scientific announced a $50 million (€44 million) expansion at a plant in St Louis, Missouri to add 16,000 L of single-use capacity. The facility is run by contract development and manufacturing organization (CDMO) Patheon, acquired by Thermo Fisher in August 2017 for around $7.2 billion. And during a Q3 financial call, Thermo Fisher CEO…

Single-use, double-digits: Robust quarters for Pall and Sartorius

by Dan Stanton

The “large molecule dynamic” underpins Pall Corporation’s continued quarterly double-digit growth, says owner Danaher. Fellow bioprocessing vendor Sartorius also saw double-digit gains in sales revenue and earnings. “Pall had a great quarter, producing double-digit core revenue growth,” Tom Joyce, CEO of Pall’s parent company Danaher Corporation told stakeholders during its recent third quarter financial call. “In particular, our biotech business, including single-use technologies was up mid-teens in the quarter.” For Danaher’s total business, Q3 sales were $4.85 billion (€4.25 billion),…