Scorpion Biological Services changes name to Scorpius BioManufacturing post-expansion

The contract development and manufacturing organization (CDMO) Scorpion Biological Services will adopt the name Scorpius BioManufacturing after unveiling expanded manufacturing capabilities earlier this year. The company opened a new biomanufacturing facility in San Antonio in October. Scorpius will be headquartered in the same city.

A string of companies have also changed their name in 2022.

The smoking cessation firm Respira became Qnovia. Adagio changed its name to Invivy

CytRx became LadRx. Bone Therapeutics turned into BioSenic.

Scorpius opted to adopt a new name that “better defines our focus and full-service offering,” explained David Halverson, Scorpius president, in a news release.

In addition to its CDMO offerings, the biologics-focused company also is a contract research organization (CRO).

The company can “take our clients’ biologic innovations through the clinic to commercialization,” Halverson said.

“We have long…

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BioVectra chief commercial officer has played a pivotal role in firm’s success

Two decades ago, the Canadian CDMO BioVectra installed Heather Delage as its director of business development. She was named vice president of business development in 2014. In 2021, she assumed the role of chief commercial officer.

At the outset of her tenure with BioVectra, the company was beginning its journey to invest in large-scale cGMP manufacturing capacity.

A 30-year veteran of the life sciences industry, Delage has been foundational to BioVectra’s evolution from a small, founder-led business offering diagnostic products, intermediates, and raw materials to a full-service CDMO.

She served as general manager in 2018 and 2019 for the company’s large-scale biologics facility startup in Windsor, Nova Scotia.

Founded in 1970, BioVectra was originally named Diagnostic Chemicals Ltd. and focused on making small amounts of specialty chemicals under contract with a U.S. company. Since Delage joined the company in 2000, BioVectra has grown tenfold i…

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Why BioVectra has big mRNA biomanufacturing ambitions

Founded in 1970, BioVectra is a CDMO with specialties in microbial fermentation, complex chemistry and biologics. The company is looking to bolster its mRNA manufacturing capability.

In November 2021, the Canadian company announced its intent to build a new $79.6 million facility dedicated to producing and manufacturing mRNA vaccines and therapeutics. The initiative resulted from a joint private-public investment from the company and federal and provincial governments in Canada.

In April, BioVectra broke ground on the 36,000 ft2 mRNA Vaccine and Biomanufacturing Center located at its campus in Charlottetown, a city on Prince Edward Island.

The funding from the Canadian government followed after officials reached out to BioVectra with the intent of building up domestic manufacturing capability for mRNA- and plasmid-DNA-based vaccines.

Government officials ultimately decided to invest in BioVectra’s expansion, which will be structured into th…

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Fujifilm to spend $1.6B to bolster cell culture manufacturing services

The multinational conglomerate Fujifilm will invest $1.6 billion to improve and ramp up the cell culture manufacturing services of its CDMO subsidiary Fujifilm Diosynth Biotechnologies.

Most of the investment will focus on a site in Hillerød, Denmark. A site in College Station, Texas, will also benefit from a funding injection.

The investment will increase the capacity of its cGMP batch manufacturing with the addition of eight 20,000L bioreactors and two downstream processing streams.

Fujifilm boasts that the Hillerød facility will be the largest end-to-end CDMO in Europe with 20 x 20,000L bioreactors for drug substance production.

The Denmark facility will also have sustainable production features. For example, it will use an electric boiler rather than one powered by natural gas. Fujifilm Diosynth Biotechnologies also will invest in technologies to curb water consumption.

Fujifilm expects the investment to create roughly 450 jobs. There a…

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Novartis refiles paperwork to FDA for novel cholesterol drug inclisiran

Novartis (NYSE: NVS) has resubmitted paperwork to the FDA for inclisiran, a subcutaneously-delivered drug candidate for treating hyperlipidemia in adults whose low-density lipoprotein cholesterol (LDL-C) remains elevated after taking a maximum tolerated dose of statin therapy.

In Dec. 2020, FDA issued a complete response letter (CRL) for inclisiran. A CRL indicates that the agency has decided not to approve a new drug application. In this case, FDA had expressed concern over unresolved inspection-related conditions at an Italian contract development and manufacturing organization (CDMO).

In a statement, Novartis announced that it plans to shift inclisiran production to its facility in Schaftenau, Austria. The company said it planned to move production of the drug to that plant before it received the CRL.

In its CRL, FDA did not relay concerns related to the safety or efficacy of inclisiran.

Novartis won EU approval for the drug in December.

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Answering the CDMO shortage: A new paradigm for drug development

Photo by Isaac Quesada on Unsplash

What can the pharma industry do about the critical shortage of contract manufacturing organization (CMO) and contract development and manufacturing company (CDMO) facilities?

For a growing number of young entrepreneurial drug companies, the answer is a middle ground between building their own facilities and outsourcing to the saturated CMO/CDMO market. This middle ground lies in hybrid flexible cleanroom facilities with wraparound support services, which are gaining greater acceptance in the pharma industry. This model allows companies to leverage their manufacturing expertise while still maintaining control of their intellectual property. This approach is particularly valuable as new therapeutic technologies emerge, which require a different competency than many of the existing CMO/CDMO facilities can handle. Hybrid flexible cleanroom facilities are likely to emerge as a n…

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