Nicholas Green, Avid Bioservices CEO

A Cal­i­for­nia biotech steps in­to the vi­ral vec­tor space with new site build of $75M

As cell and gene ther­a­py gets hot­ter, a Cal­i­for­nia CD­MO has made a play to open an en­tire­ly new arm of its op­er­a­tions to fill a void in the mar­ket.

Avid Bioser­vices will move in­to the cell and gene ther­a­py mar­ket, with the con­struc­tion of a 53,000 square-foot vi­ral vec­tor cGMP man­u­fac­tur­ing site down the road from its Tustin, CA head­quar­ters.

The site will be com­plet­ed with­in 18 months, with CEO Nicholas Green say­ing that Jan­u­ary 2023 is an an­tic­i­pat­ed open­ing date. If the project stays on track, its an­a­lyt­i­cal and process de­vel­op­ment labs could be ready for par­tial use in the next six to eight months.

The in­vest­ment fol­lows an in­vest­ment in man­u­fac­tur­ing in Tustin, which un­der­went phase two of the build­ing process in Feb­ru­ary. The en­tire build will cost some­where in the range of $65 mil­lion — $75 mil­lion, and brings the com­pa­ny’s po­ten­tial rev­enue ca­pac­i­ty up to around $350 mil­lion.

Avid’s de­ci­sion to en­ter this space comes from the CD­MO in­dus­try’s lack of a pres­ence in high qual­i­ty cGMP vi­ral vec­tor man­u­fac­tur­ing.

”We kind of got a lot of our ducks in a row and saw that part of the busi­ness per­form­ing quite nice­ly,” Green said in a call with End­points News Wednes­day. “We start­ed look­ing around the field at the var­i­ous dif­fer­ent ar­eas of bi­o­log­ics man­u­fac­tur­ing that we thought would be of in­ter­est, and in some of my quar­ter­ly calls, I’ve high­light­ed those dif­fer­ent ar­eas…we kind of did some deep dives and dili­gence, and the feed­back we got was what we con­sid­ered to be our core strengths…and this seemed like a sen­si­ble and log­i­cal move.”

Drew Bren­nan

With the an­nounce­ment, the com­pa­ny al­so wel­comed Drew Bren­nan aboard as the new­ly ap­point­ed gen­er­al man­ag­er of vi­ral vec­tor tech­nolo­gies. He comes from No­vasep, a US CD­MO that fo­cus­es on vi­ral vec­tor man­u­fac­tur­ing in which he spent 12 years, and re­cent­ly over­saw the con­struc­tion of sev­er­al new sites in Bel­gium. There will cer­tain­ly be more per­son­nel an­nounce­ments, as Avid be­gins to put its team to­geth­er. But the chal­lenge lies in the need to find a high­ly com­pe­tent team with pri­or vi­ral vec­tor ex­pe­ri­ence.

“It is very spe­cif­ic tech­nol­o­gy, and there­fore, in­di­vid­u­als who have ex­pe­ri­ence in a wide va­ri­ety of dif­fer­ent vec­tors, a wide va­ri­ety of dif­fer­ent ex­pres­sion sys­tems, that’s a huge plus,” Bren­nan said. “Even though a lot of the tech­nol­o­gy is cen­tered now around AAV as well as lentivec­tor, there’s still a lot of oth­er vec­tors out there, retro­virus, al­phavirus. It’s very im­por­tant that we have a team that is well-versed in these types of vec­tor sys­tems.”

In De­cem­ber, the biotech gen­er­at­ed some $34.5 mil­lion in rev­enue when it closed the of­fer­ing of its pub­lic stock. Dur­ing its 2022 Q1 call, the com­pa­ny an­nounced its rev­enue was up 20% from last year, to $30.8 mil­lion.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Franz-Werner Haas, CureVac CEO (Christoph Schmidt/picture-alliance/dpa/AP Images)

Tak­ing an­oth­er shot at mR­NA glo­ry, Cure­Vac inks on­col­o­gy pact while keep­ing up with Covid work

CureVac may have lost out on the initial mRNA race to bring a Covid-19 vaccine to the market, but it’s still eager to prove that it has what it takes to be a serious player in the field.

As it updates investors on its second-generation vaccine candidates for infectious diseases in Q1 results, the German biotech says it’s beefing up its oncology pipeline.

To that end, it has struck a new collaboration with Belgium’s myNEO, which boasts of a neoantigen discovery and selection platform, to identify new targets for mRNA immunotherapies.

Paul Chaplin, Bavarian Nordic CEO

Bavar­i­an Nordic nets ma­jor vac­cine con­tract to re­spond to mon­key­pox out­break

The current monkeypox outbreak is now at a phase where some governments are approaching a point of concern, at least enough to start stockpiling vaccines.

In response, at least one government is placing its order with vaccine manufacturer Bavarian Nordic to secure sufficient supply for vaccinating individuals. According to the company, it has inked a supply contract with an undisclosed country for the company’s smallpox vaccine, called Jynneos. The aim is to ensure there will be enough supply to meet the undisclosed country’s requirements for vaccinating individuals at risk for monkeypox in the short to medium term. The vaccine is approved for use against monkeypox by the FDA and Health Canada.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.