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Cold Chain Excellence: Getting Control Over Freezing of Biologics

HOW CONTROLLED FREEZING ENABLES SCALABILITY: Controlling the freezing behavior of drug substance is the ultimate goal in pharmaceutical manufacturing. It opens doors to process reproducibility, consistent quality of the final drug product by maintaining uniform conditions for the biopharmaceuticals during freezing and consequently for frozen storage and shipment. As one of the most essential parameters to achieve control over freezing & thawing bulk, the freezing rate has been considered and evaluated in different tests. The leverage of the ice front…

Coherus: FDA calls for quality process change in toripalimab CRL

Coherus and partner Junshi will resubmit the BLA for toripalimab by mid-summer after the US FDA requested a quality process change. Coherus BioSciences announced this week itself and partner Junshi Biosciences received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its metastatic nasopharyngeal carcinoma (NPC) candidate toripalimab. Toripalimab was first approved in China to treat melanoma in 2018, but Coherus acquired the North American right to the anti-PD-1 antibody in February 2021 through a…

Takeda opens Ireland’s first stem cell facility

Takeda has opened its $43 million facility in Grange Castle, Ireland, which will help supply cell therapy treatment options to the EU, Canada, and the US. Takeda Ireland, a subsidiary of Takeda Pharmaceutical Company, announced a €36 million ($43 million) investment February 2021 to build Ireland’s first commercial-scale cell therapy production facility. At the time of the announcement, Takeda declined to disclose what cell therapies it planned to manufacture at the site located 10km west of Dublin. However, the firm…

Comprehensive Virus Clearance Evaluation Using Micro-Scale Membrane Adsorbers

This webcast features: Sherri Dolan, Global Technology Consultant for Virus Clearance, Sartorius. When it comes to establishing a viral clearance process, ensuring patient safety is a top priority. To ensure this, regulators require that manufacturing processes have a validated cGMP purification process that can remove and/or inactivate a variety of viruses. Additionally, process efficiency and cost, among other factors, play a role in small- and large-scale manufacturing processes. Many biopharma manufacturers are not yet utilizing the full loading potential of…

Biogen and Aduhelm: ‘Manufacturing capabilities will align with demand’

With minimalized demand for the one-time touted blockbuster Aduhelm, Biogen could be left with 198,000 L of mammalian capacity to fill. Between its Swiss site in Solothurn and a plant in North Carolina, Biogen said last year it has a combined capacity of 198,000 L, capable of producing tens of millions of doses of Alzheimer’s drug Aduhelm (aducanumab). However, despite the US Food and Drug Administration (FDA) approving Aduhelm in June 2021, the commercial future of the monoclonal antibody (mAb)…

Keys to Establishing a Robust Mammalian Cell Line Development (CLD) Platform

Risk management and the establishment of a robust mammalian cell line development (CLD) platform is key in the effort to bring biologics into the clinic as quickly as possible while also achieving high productivity and maintaining expected product quality. Utilizing the same mammalian cell platform early in the lead molecule discovery efforts as that used for eventual GMP production provides critical manufacturability and developability data while also delivering consistent cell culture growth characteristics and product quality and titer information to…

Maturing gene therapy pipelines driving Catalent growth and expansion

As pharma’s gene therapy pipeline matures, Catalent plans to invest more in the sector to meet high viral vector demand and advance growth. For the third quarter 2022, contract development manufacturing organization (CDMO) Catalent reported total revenues of $1.27 billion, an increase of 21% year-on-year. Catalent’s biologics segment came out as the top contributor to the CDMO’s financial performance, showcasing $698 million, representing net revenue growth of 30%over last year. Part of this success was due to “a notable increase”…

Podcast: Biopharma’s evolving relationships with CDMOs

M&A, new modalities, and COVID-19 have all changed the way drug sponsors work with their third-party manufacturers, according to delegates from Samsung Biologics, Catalent, and AGC Biologics. The BioProcess Insider Expression Platform (BIEP) podcast is back, with an in-depth look at the evolving relationships between biopharma and their contract development and manufacturing organization (CDMO) partners. Recorded live from EBD’s BIO Europe Spring event last month, BioProcess Insider discussed the changing dynamic and reliance drug sponsors have with their CDMOs with:…

Pfizer pledges to pull out of Russian manufacturing pacts

Pfizer says it is ceasing all future investment to build manufacturing capacity in Russia due to Vladimir Putin’s war against Ukraine. Putin’s universally criticized invasion of Ukraine has sent shockwaves across the world, with the pharma industry just one of many affected. Clinical trials have been disrupted, and the deepening conflict has driven concerns surrounding supply chains. Big Pharma has had a mixed response regarding its presence in the area, but several companies have announced they have scaled back activities…

PE firm Astorg to buy CordenPharma from ICIG

Astorg Partners has signed an agreement with International Chemical Investors Group (ICIG) to acquire CDMO CordenPharma. According to French private equity firm Astorg, ICIG chose to sell contract development manufacturing organization (CDMO) CordenPharma after a strategic portfolio review, which concluded its aim to focus more on its chemicals portfolio. Under the terms of the deal, ICIG  will reinvest as partners with Astorg to develop CDMO would further. “We look forward to having the opportunity to partner with ICIG and [CordenPharma’s]…