Outsourcing channel feed

CPhI: The time of the CMO is up­on us as mas­sive in­dus­try growth dri­ves surge in out­sourc­ing ca­pac­i­ty

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: As pan­dem­ic reach­es its fi­nal stages, an in­dus­try busier than ever re­flects on lessons learned

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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Catalent CEO John Chiminski (Jeff Rumans)

Catal­ent wraps up San Diego site build­out as it con­tin­ues to make waves with glob­al ac­qui­si­tions

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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Charles Riv­er Lab­o­ra­to­ries has been on an ac­qui­si­tion spree. But Tues­day, it of­floaded two as­sets

Following a summer filled with mergers and acquisitions, Charles River Laboratories has divested its research operations in Japan and a CDMO site in Sweden, engineering two separate deals expected to cut down $20 million in revenue.

Tuesday, Charles River sold its gene therapy CDMO site to a private investor group for about $52 million in cash, with the potential for contingent payments up to $25 million. The site was in the company’s possession for only a few months, as it was acquired from Cognate BioServices on March 29.

Mark Sitcoske, High Purity New England CEO

New Eng­land-based dis­trib­u­tor HP­NE looks to dou­ble its work­force to keep up with de­mand

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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Henrietta Lacks (Via Johns Hopkins Medicine)

Es­tate of Hen­ri­et­ta Lacks sues Ther­mo Fish­er over the im­prop­er sale of her im­mor­tal cells

The family of a black woman whose immortal cells were unethically taken from her at Johns Hopkins hospital in 1951 is now suing Thermo Fisher Scientific for profiting from the cells for decades.

The world-famous cell line, known for Henrietta Lacks as HeLa and the subject of a bestselling book about a decade ago, have proven to be incredibly important in human history, helping scientists to make major strides, from the polio vaccine to in vitro fertilization.

FDA calls for re­peat bioe­quiv­a­lence stud­ies af­ter un­cov­er­ing 'in­valid' da­ta from two In­di­an CROs

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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Con­tract re­search is hav­ing a mo­ment right now. Will M&A splash­es dri­ve the in­dus­try to even greater heights?

Contract research organizations are a fairly mysterious bunch. They’re typically considered the skilled laborers behind big drug development — the stage crews who run the trials behind some of the most (and least) successful data reveals in biopharma history.

But all that is changing.

This year, a couple of huge, out-of-the-blue M&A deals sounded the alarm on just how much money is flying around in this corner of the industry.

John Kreger, an analyst at William Blair, estimates that about half of all clinical trial work is outsourced to contract research organizations, also known as CROs. In recent years, the companies have slowly begun to take on a new look, with services now ranging from consulting to manufacturing and commercialization. It’s an industry that’s projected to reach $90 billion by 2026, according to Fortune Business Insights. 

“No one has great data about how big this market is or how much is outsourced. Everyone’s dealing with estimates,” Kreger said.

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Catalent CEO John Chiminski

Catal­ent inks deal with Phath­om to make GI drug at re­cent­ly-ren­o­vat­ed Ken­tucky site

Summer’s over, but New Jersey-based CDMO Catalent had time to squeak in one last deal.

Catalent has signed an agreement to commercially manufacture Phathom Pharmaceuticals’ lead drug, vonoprazan, for the treatment of gastrointestinal diseases. If the drug is approved by the FDA, Catalent will manufacture and package the drug at its large-scale oral solid dose site in Winchester, KY. Phathom has the rights to develop and commercialize vonoprazan in the US, Europe and Canada.

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Kent Payne, BioDuro-Sundia

Bio­Duro-Sun­dia plants its flag at for­mer Par man­u­fac­tur­ing site in CA

A former Par Pharma site in Irvine, CA, will now have a new tenant.

BioDuro-Sundia will acquire a 40,000-square-foot oral solid dose manufacturing site in Irvine, the company announced Monday.

The site will allow the company to scale up and cater to companies that need larger-scale production, Kent Payne, the president of development and manufacturing, said in a press release. The new site should be operational by the start of 2022. It will be able to produce 1 billion tablets and capsules a year, the company said.