Contract manufacturers are having a moment, and it hasn’t gone unnoticed by the folks at CPhI.

The organization’s annual report found that CMOs will account for four of the five top companies by manufacturing capacity in 2025. Dawn Ecker, a CPhI expert, predicts that the biologics manufacturing volume will grow 8% a year to that deadline, expanding from 2,700kL in 2020 to 3,900kL in 2025.

Nearly half of all capacity will shift from in-house manufacturing to CMOs and hybrid companies, her findings revealed, and if trends stay consistent, the big-dog contractors will have the largest capacity volume. Those four are Korea’s Samsung Biologics, Switzerland’s Lonza, WuXi Biologics, and Fujifilm Diosynth Biotechnologies.

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CPhI week is always a time each year to reflect on the manufacturing world writ large, and this year’s event is no different.

Normally, Endpoints News would be on site this week in Milan — we hired dedicated manufacturing reporter Josh Sullivan to cover events exactly like this, after all — but ongoing concerns over the pandemic have kept us homebound for now. But this week still holds a special place for us, and I thought one way to reflect on where biopharma manufacturing has gone in the past 12 months would be to hit on a few of the biggest trends and events we’ve reported on.

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Just weeks after Catalent opened a newly acquired site in Shiga, Japan, the CDMO giant announced the opening of a new facility in San Diego to up its clinical packaging and distribution solutions on the West Coast.

The facility is 24,000 square feet and located within a mile of the company’s early-phase oral drug product center of excellence. It supports clinical studies for Phases I through III, and end-to-end services.

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In 2019, High Purity New England, a biopharma solutions and equipment supplier and distributor based out of Smithfield, Rhode Island, had just 60 employees. Thanks to a push in demand, largely fueled by the pandemic, it hopes it can end the year 2022 with 350.

The hiring push is all part of the company’s plan to open a new facility in December, a $10 million project that would triple its manufacturing output and bring its total square footage to more than 100,000. All three buildings will be located on the same street, and the new site will be used to create a sixth clean room for manufacturing, a distribution center, a lab and more office space.

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After finding “significant instances of misconduct and violations of federal regulations,” leading two Indian CROs to submit “invalid study data to FDA,” the agency is now calling on certain unnamed generic and brand name drug companies to run bioequivalence tests again for some of their marketed products.

The FDA said that after looking into the clinical and bioanalytical studies conducted by Synchron Research Services in Gujarat, India, and Panexcell Clinical Lab in Maharashtra, India following an inspection in late Nov. 2019, data from either company are no longer acceptable to support a determination of safety or effectiveness for brand name drugs, or to show affected generic drugs are bioequivalent to their brand name counterparts.

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