Global Markets

How to avoid a post-COVID manufacturing crisis

How pharmaceutical companies should plan to catch up after the pandemic and explain what happened to inspectors. It is important to start planning for post-COVID-19 recovery even as the pandemic continues to impact pharmaceutical manufacturing operations, an expert panel told Food and Drug Law Institute members during a 19 May webinar. Manufacturers should set priorities in advance so they can attack the most important backlogged activities first. They also should approach recovery with the right mindset: the need to act…

In brief: GSK inks $231m ‘flexible’ deal with Samsung BioLogics

GSK says the eight-year agreement with the Korean CDMO brings additional and flexible capacity to manufacture its innovative biopharmaceutical therapies. UK-headquartered pharma giant GlaxoSmithKline (GSK) has an extensive manufacturing network to support its biologics product portfolio but has turned to contract development and manufacturing organization (CDMO) Samsung BioLogics to secure capacity for future needs. The deal will see Samsung Biologics provide GSK with additional capacity for large-scale biomanufacturing from its site in Incheon, South Korea. The capacity will be flexible…

AZ aims to ship Oxford’s COVID vaccine from September using BARDA’s $1bn

AstraZeneca says $1 billion from the US Biomedical Advanced Research and Development Authority (BARDA) will fund production of Oxford University’s SARS-CoV-2 vaccine. The Anglo-Swedish drug firm said it would begin production of the vaccine candidate – previously known as ChAdOx1 nCoV-19 and now called AZD1222 – in the autumn. It added that the BARDA funding will also support a support a Phase III trial involving 30,000 participants and a pediatric study. AstraZeneca set the funding as part of an effort to…

Continuous manufacturing back in second Act

House tries again to promote advanced technology for the return of pharmaceutical manufacturing to the US in post-COVID-19 era. The new HEROES Act legislation revives a proposal to establish national centers of excellence for continuous pharmaceutical manufacturing that had earlier made it into the US House of Representatives’ version of the CARES Act but not the final enacted CARES pandemic relief law. The HEROES bill (HR 6800) authorizes $100 million for the centers of excellence, available until expended. That’s up from the $80…

Swiss biomanufacturing revived in 2019 says industry group

Swiss biomanufacturing had a “resurgence” in 2019 according to an industry group which cited plant investments by drug firms and CDMOs as growth drivers. The Swiss Biotech Association – which represents biopharmaceutical companies, biotech and the services sector – made the comments in a recently published report. It wrote that, “Switzerland’s manufacturing prowess has experienced a revival in 2019, following years of “exporting” manufacturing capabilities aboard.” The organization highlighted Biogen’s decision to invest CHF 1 billion ($1 billion) in a…

Takeda warns of failures and bottlenecks in COVID vaccine rush

Takeda says it is looking to partner to enter the COVID-19 vaccine race but warns industry of the difficulties of developing and manufacturing such products. Industry’s response to the coronavirus pandemic has been unprecedented. According to data provided by Pharma Intelligence, there are – as of Friday 15 May – 116 vaccines in development against COVID-19, nine of which are being trialed in humans. But while pharma giant Takeda has welcomed the surge in COVID-19 programs, CEO Christophe Weber has…

BioMarin prepares to launch Roctavian for hemophilia in an uncertain environment

The company lowered revenue guidance due to COVID-19, but announced a new brand name, Roctavian, for its hemophilia A gene therapy, which it said remains on track for FDA approval later this year. BioMarin Pharmaceutical is still on track to launch the first gene therapy for hemophilia A in the US later this year, but acknowledged during its first quarter sales and earnings call on 29 April that the commercial dynamics are uncertain because of the COVID-19 outbreak. Management unveiled a…

UK Gov teams to aid academic gene therapy developers source vectors

Academics developing gene therapies often struggle to source vectors say the MRC and Lifearc, which plan to set up UK viral vector production network. The Medical Research Council (MRC) – a non-departmental government agency – and Lifearc – a research charity – announced plans for the network and a £16 million ($20 million) fund for the project on May 4. The idea is to provide grants UK-based research organizations can use to expand vector suites or repurposed facilities to make…

Pfizer, Sanofi, Novartis and Merck plants open during pandemic

Biopharmaceutical manufacturing is weathering COVID-19 relatively unscathed thanks to multi-sourcing strategies and newly available transport capacity. The coronavirus pandemic and the social distancing measures used to slow the spread of the virus have seen biopharmaceutical companies suspend trials and revise financial forecasts. Manufacturing, in contrast, appears to have suffered less impact judging by recent comments by leading manufacturers. For example, last week Pfizer CEO Albert Bourla told analysts the firms manufacturing sites and related distribution channels operational are operating “without…

COVID-19 an opportunity for outsourcing sector, say leading CDMOs

COVID-19 has increased demand for outsourcing but it is too early to tell what long term impact the pandemic will have, say leading CDMOs. Lonza has received more than 40 inquiries about COVID-19 related projects, says CEO Albert Baehny. He told analysts the pandemic “has already offered some new and important opportunities, which are currently under review.” He added, “Inevitably we cannot engage and collaborate in all of those projects. Instead, we are focusing our efforts on selected key development…