Services

We pro­vide ful­ly anaer­o­bic GMP man­u­fac­tur­ing ser­vices for live bio­ther­a­peu­tic prod­ucts (LBPs), sup­port­ing Phase 1 and Phase 2 clin­i­cal pro­grams as well as GLP tox­i­col­o­gy stud­ies. Our inte­grat­ed plat­form com­bines strain iso­la­tion, process devel­op­ment, ana­lyt­ics, and drug prod­uct man­u­fac­tur­ing to enable reli­able pro­duc­tion of com­plex anaer­o­bic micro­bial con­sor­tia at clin­i­cal scale. 

We part­ner with clients seek­ing high-qual­i­ty man­u­fac­tur­ing for anaer­o­bic micro­bial prod­ucts sup­port­ing Phase 1 & 2 clin­i­cal tri­als or GLP tox stud­ies, with batch sizes up to 250 L. 

GMP man­u­fac­tur­ing slots are cur­rent­ly avail­able begin­ning Q3 2026. 

• Anaer­o­bic con­trol pre­serves via­bil­i­ty of sen­si­tive strains end-to-end.
• Tight tem­per­a­ture con­trol ensures prod­uct con­sis­ten­cy and quality.
• Closed sin­gle-use design min­i­mizes con­t­a­m­i­na­tion risk. Scal­able and flex­i­ble plat­form sup­ports mul­ti­ple pro­grams and vol­umes (5L to 250L).
• Cell con­cen­tra­tion via tan­gen­tial flow fil­tra­tion sys­tems pro­tects frag­ile cells from lysis dur­ing formulation.

• Closed anaer­o­bic work­flow enables end-to-end, oxy­gen-free han­dling to pre­serve the via­bil­i­ty of strict anaerobes.
• High-through­put man­u­fac­tur­ing pro­vides auto­mat­ed cap­sule fill­ing at 1,200 capsules/​hour.
• Inte­grat­ed cap­sule fin­ish­ing includ­ing over-encap­su­la­tion, weight check, and bot­tle fill in one con­trolled assem­bly line.
• Real-time QC, includ­ing in-line cap­sule weight mon­i­tor­ing, guar­an­tees precision.
• GMP-ready prod­ucts that include induc­tion-sealed, bot­tled, and labeled unit doses.