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Endpoints Manufacturing

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Man­u­fac­tur­ing roundup: New Hous­ton-based bio­man­u­fac­tur­ing site com­ing; UK cell and gene ther­a­py cen­ter opens

A joint venture between Vitrian, a provider of biomanufacturing facilities, and the Howard Hughes Corporation will bring manufacturing facilities to the Houston suburb of the Woodlands, TX.

According to a press release, the area has several companies nearby, including Millipore Sigma and KBI Biopharma. The joint venture aims to meet the needs of local companies by providing a manufacturing facility in the Woodlands for use by local biotechs and CDMOs as well.

LG Chem nets $200M con­tract to man­u­fac­ture sev­er­al vac­cines

The South Korean chemical and life science producer LG Chem has roped in a multimillion-dollar contract to produce its polio vaccine.

LG Chem has secured a manufacturing contract worth $200 million for UNICEF to produce its polio vaccine called Eupolio and the pentavalent vaccine Eupenta, which is designed to prevent diphtheria, tetanus, hepatitis B, meningitis and pertussis.

LG Chem will produce $100 million-worth of its polio vaccine for two years, from 2024 through 2025. The contract for Eupenta will produce $100 million-worth of the vaccine for the next five years, starting this year through 2027. While no exact production amounts were given, LG Chem stated in its release that it will be supplying vaccines for around 80 million children globally.

Steven Favaloro, incoming Genezen CEO (L) and Mark Womack, incoming BioCina CEO

Con­tract man­u­fac­tur­ers BioCi­na and Genezen name new CEOs

A pair of CDMOs are bringing in new CEOs.

Taking the helm at BioCina is Mark Womack. According to his LinkedIn profile, Womack has been in leadership positions at several contract manufacturers. His career spans more than 30 years, including roles such as CEO of the contract manufacturer KBI Biopharma and Selexis SA. Before that, he was CEO of Stelis Biopharma and chief business officer of Seattle-based manufacturer AGC Biologics.

Brook­ings pan­el of ex­perts lays out case for on­shoring man­u­fac­tur­ing

As the US and Europe continue to consider onshoring pharma manufacturing to shore up the international supply chain, a panel of experts, hosted by the Brookings Institution, addressed how to shore up supplies and resiliency as drug shortages and other supply issues persist after the pandemic’s initial impact.

Speaking on lessons learned from the pandemic, Tom Bollyky, director of the Global Health Program and Senior Fellow for Global Health, Economics and Development at the Council on Foreign Relation, said that while there was general success in moving billions of doses of the Covid-19 vaccine once it became more widely available, there were still some difficulties. More than two-thirds of countries had export restrictions on essential medical products during the pandemic, Bollyky said.

Bris­tol My­ers blasts off with SpaceX to study bio­man­u­fac­tur­ing in space

The launch of SpaceX’s Dragon spacecraft from Cape Canaveral last night had more on board than just supplies for the International Space Station. It also contained research materials, including some from Bristol Myers Squibb.

BMS’ project to study the crystallization of biotherapeutic compounds in microgravity is one of about 20 research projects on board, according to a press release from the International Space Station National Laboratory. The BMS research will investigate how the crystallization process could improve biomanufacturing and eventually provide delivery of higher doses of proteins.

The Avextra team (L-R): co-CEO Bernhard Babel, COO Neil Smith, co-CEO David Reckeweg-Lecompte and CSO Marla Luther

Ger­man cannabis med­i­cine man­u­fac­tur­er lands $17M+ in fund­ing

The German-based cannabis medicine producer Avextra has reeled in some new funds while also looking to expand its reach within Europe.

Avextra announced Wednesday that it secured a total of €17 million ($17.9 million) in a capital raise. The company said in a release that the cash will be going toward several avenues of its business, which include expanding the sales of its current products in new markets in Europe and boosting the development of new cannabis-based medicines and products. Avextra also plans to expand its research and development work and grow its presence in Portugal, where the company has a cultivation facility.

EU lays out pros and cons to on­shoring more API pro­duc­tion

As the US embarks on a billion-dollar initiative to onshore active pharmaceutical ingredient (API) manufacturing, the European Union released a report earlier this month weighing the pros and cons of any possible reshoring of API production.

The 58-page report notes that over the past decade, medicine shortages have been increasing throughout Europe, as they have across the pond, with concerns raised that outsourcing API manufacturing abroad may have contributed to disruptions in the supply chain. A proposal to reshore API manufacturing to EU member states has been proposed, but it’s unclear if it will gain traction.

Salim Haffar, PCI Pharma Services CEO

PCI Phar­ma Ser­vices to in­vest $50M to boost pro­duc­tion at Illi­nois cam­pus

Philadelphia-based contract manufacturer PCI Pharma announced on Tuesday plans to invest $50 million to build a new 200,000-square-foot manufacturing facility at its campus in the city of Rockford, Illinois.

According to a statement from the company, the new facility will have over 20 manufacturing suites and the ability to assemble and package vials, pre-filled syringes and other injectable medicines. It will also produce medicines designed to treat diabetes and obesity as well as manufacture drugs for oncology and autoimmune diseases.

GAO to FDA: Do more to en­cour­age drug man­u­fac­tur­ing in­no­va­tion

The Government Accountability Office on Friday released a report calling on the FDA to better encourage the adoption of advanced drug manufacturing practices, particularly as interviews with 15 stakeholders from industry said delays in adopting advanced tech are related to regulatory uncertainties.

In addition to not encouraging more advanced manufacturing practices, like continuous manufacturing, GAO found that the FDA “lacks information on the extent to which its industry engagement and policy and guidance efforts encourage adoption of advanced manufacturing.” What’s more, the FDA has not even defined or documented its goals in this area, GAO found.

Mod­er­na looks to the West Coast for lat­est ex­pan­sion

Moderna’s physical presence in the US has mainly been confined to the East Coast. But now it will be planting its flag on the West Coast.

The mRNA biotech announced Friday that it will be opening two new offices in South San Francisco and Seattle this year. Moderna chief information officer Brad Miller told Endpoints News the Seattle office is slated to open April 4.

The Seattle location will be housing Moderna’s efforts in technology and implementation of AI and cloud tools across its platform. Miller said that Seattle is home to a rich market of tech talent, which makes it an attractive choice for an office. Moderna will look to hire around 100 employees but has room to bring that number up to around 220.