As Catal­ent ven­tures fur­ther in­to the world of cell and gene ther­a­py man­u­fac­tur­ing, the New Jer­sey-based CD­MO has re­vealed its new ade­no-as­so­ci­at­ed vi­ral vec­tor plat­form.

The Up­Tem­po Vir­tu­oso plat­form can stream­line the AAV man­u­fac­tur­ing process to cut back on the time it takes to go from clin­ic to in-hu­man clin­i­cal tri­als. It in­cludes pro­to­cols for cell cul­ture, trans­fec­tion, and down­stream pu­rifi­ca­tion, and can sim­pli­fy the crit­i­cal sup­ply chain. It’s de­signed to pro­duce prod­ucts for the clin­ic in just nine months, Catal­ent says, and cus­tomers will have ac­cess to Catal­ent’s plas­mid DNA of­fer­ings, too.

In a state­ment, C&GT Pres­i­dent Man­ja Boer­man said:

“As one of the first CD­MOs to suc­cess­ful­ly de­vel­op a sus­pen­sion-based tran­sient trans­fec­tion process, and our deep and spe­cial­ized vi­ral ex­per­tise and broad ex­pe­ri­ence across more than 70 vi­ral vec­tor pro­grams, we have built this new process with the goal of pro­vid­ing our cus­tomers with a re­li­able, re­pro­ducible, and scal­able path to clin­ic. As the gene ther­a­py pipeline ex­pands to a broad­er dis­ease port­fo­lio, and in an­tic­i­pa­tion of ris­ing reg­u­la­to­ry re­quire­ments, our op­ti­mized and stan­dard­ized CGMP man­u­fac­tur­ing process is de­signed to meet ro­bust CMC sub­mis­sions for AAV gene ther­a­py prod­ucts, while pro­vid­ing cus­tomers with the ad­van­tage of short­ened time­lines.”

The plat­form will be fea­tured at its Mary­land-based net­work in Bal­ti­more and Gaithers­burg, as well as com­mer­cial scale man­u­fac­tur­ing at BWI Air­port. pDNA pro­duc­tion is car­ried out in Rockville, MD and Gos­selies, Bel­gium.

At the end of May, Catal­ent ex­pand­ed its nasal drug de­vel­op­ment and man­u­fac­tur­ing op­er­a­tions in Mor­risville, NC. Its dou­bling down on an ex­pand­ing in­to new drug de­liv­ery forms, adding on­to its ac­qui­si­tion of the gum­mies mak­er Bet­tera in Au­gust 2021.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.