JA

Joe Adams

30 years · Boehringer Ingelheim · former VP Process Chemistry

Process ChemistryPeptide SPPSGMP Scale-upHydrogenation

JA · in his own words

“We lost a 14-kg lot at BI in 2017 because someone skipped post-Aib capping. The rule wasn't in any SOP. It was in three of our heads. That kind of one-line constraint is exactly what Krux now flags before a draft goes out.”

Background

Joe spent 30 years at Boehringer Ingelheim across the Petersburg, VA and Ingelheim, Germany sites, leading process development teams from gram scale through commercial launches. As VP of Process Chemistry his groups delivered the cGMP launch routes for two top-30 small molecules and contributed to four peptide programs that reached Phase 3.

He retired from BI in 2024. Before joining Krux as a founding advisor, he was on the technical advisory boards of two CDMOs and consulted directly with three top-10 sponsors on peptide scale-up.

Joe authored 22 patents, most of them on hydrogenation and SPPS coupling protocols still used at BI today. His Aib coupling protocol (pre-formed Fmoc-Aib-OPfp esters with mandatory post-Aib capping) became internal SOP at BI in 2018 after the 2017 incident.

One save that mattered

Caught a 22-kg API failure mode in pre-clinical, before it scaled.

In 2019 a partner CDMO running BI's peptide on contract was about to release the GMP campaign on the basis of a single coupling-yield audit. Joe flagged the ninhydrin recoupling cadence on the Aib step, ran one extra audit across cycles, found an off-by-one error in the recoupling threshold, and had the campaign re-run. The corrected campaign released first time. The original would have failed Phase 1 specs.

→ Direct save: ~$2.4M campaign + 11 weeks. Indirect save: kept the IND timeline intact for a $400M-NPV program.

4 codified protocols

What Joe taught Krux.

Each protocol below was captured 1-on-1 over interview sessions, validated against batch records, and is now grounding live RFP responses for TCG GreenChem.

kb-a-1Process Chem

Aib coupling: pre-formed OPfp protocol

HBTU/HOBt gives 70–85% coupling on Aib due to steric hindrance from the gem-dimethyl group. Industry standard since ~2015 has been pre-formed Fmoc-Aib-OPfp esters with 90-min cycles. Capping post-Aib is non-negotiable. Lost a 14 kg lot at BI in 2017 by skipping it.

captured 2026-03-14 · used in 5 drafts

confidence94%

kb-a-4Pricing

GLP-1 analog peptide market: pricing band

GLP-1 analog peptide CDMO programs Phase 2 supply, 30–50 kg scale, currently price $1.8–2.6M. Top-3 CDMOs at +18% premium. Tier-2 winning on price + speed combination, not price alone. Don't go below $1.7M unless commercial rights are firm.

captured 2026-04-02 · used in 4 drafts

confidence88%

kb-a-6Process Chem

Hydrogenation: when to pre-screen for Pd leaching

If a route uses Pd/C above 70 °C and the API has a heteroaromatic accepting group, run an ICP-MS Pd-leaching pre-screen on a 10-g engineering batch BEFORE committing reactor time. Saves a campaign re-run when the spec is <10 ppm.

captured 2026-03-22 · used in 3 drafts

confidence91%

kb-a-9Capability

Cryogenic ramp validation: 3-run rule

Never claim cryogenic capability above the validated batch size. A 20→50 kg scale-up requires three engineering runs at the new ceiling. Anything less and FDA will RFI on it. Ramp validation cost is roughly $180K plus 6 weeks of plant time. Plan it as a separate work package, not a freebie inside a GMP campaign.

captured 2026-04-04 · used in 6 drafts

confidence93%

Try it

See Joe’s protocols flagging an RFP

Open the BX-3142 workspace → look for JA citations →

Other founding advisor

CR

Chris Reyes

See codified protocols →