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.

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.

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.

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.

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.

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.