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.

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

A relatively quiet Minneapolis-based CDMO is making waves, announcing its third acquisition in just one week.

Pace has acquired Velesco Pharmaceuticals Services, which will add to its liquid, semi-solid and oral solid dose manufacturing, the company said. The CDMO has also brought on BC Laboratories out of California and ProScience Analytical Services

The Velesco acquisition allows Pace to broaden its drug delivery options, and tailor them for clients’ modules, dose range and drug delivery route. With the acquisition, Pace will get Velesco’s clinical trial manufacturing capacity, which includes specialized, small-scale customized experiments, softgel capsule, suspension and non-sterile liquid drug support and expertise in non-clinical toxicology studies.