From Downstream Products to Five Applications
It starts with the products. PAN-Biotech's downstream range - concentrated buffers and stock solutions, DMF-backed utilities and WFI Beyond - is the foundation five modalities are built on. Each one covered in full, from upstream to downstream, on a single GMP-grade range.
One shared core, five applications covered in full
PAN-Biotech built the downstream range first - the concentrated buffers, universal stock solutions, DMF-backed utilities and WFI Beyond that every purification and formulation step depends on. Downstream is where the modalities converge: monoclonal antibodies, cell & gene therapy, vaccines and mRNA all run on the same buffer chemistry. From that shared core outward, PAN covers each application in full - upstream media and supplements included - so a whole process comes from one manufacturer, one quality system, one regulatory framework.
Select a modality
Each modality is covered in full - upstream through downstream - on the same GMP-grade range. All five processes are live now.
In depth, per application. Edition A02 · Monoclonal antibodies · Edition A03 · Cell & gene therapy · Edition A04 · mRNA · Edition A05 · Vaccines - and for the shared core, Edition D01 · Downstream and D02 · Water. All editions: In-Depth Industry Editions.
The shared downstream core
The reason one range covers five applications is that they lean on the same downstream products. A small set of concentrated stock solutions - WFI, DPBS, NaCl 5 M, Tris-HCl, phosphate, acetate, histidine and citrate - recurs across every workflow; filed FDA Drug Master Files sit behind DPBS and WFI; and every downstream buffer can be taken beyond compendial with WFI Beyond. Add the upstream media and supplements for each modality, and the coverage is complete.
Technical papers
The Open Downstream
Why downstream is where cost, quality and regulatory risk concentrate - and how owning the options takes the risk off the table.
Read the paperBeyond Compendial - Buffers & Reagents
The impurity dossier - elemental impurities, residual solvents, nitrosamines, leachables - mapped to mAb, mRNA, cell & gene and vaccine.
Read the paperFrom Bench to GMP
The make-versus-buy decision for process buffers - the five hidden costs of staying in-house at GMP scale, and how to organise the switch.
Read the paperWFI Beyond
Water for Injection engineered beyond the compendial monograph - the opt-in quality ceiling under every buffer, in every modality.
Read the paperThe Water in the Powder
A liquid medium is about 99% water - why the reconstitution water is the unmeasured half of a media powder's impurity budget.
Read the paperChoosing a Viral-Inactivation Detergent
Four requirements - performance, compliant supply under REACH, animal origin and per-lot documentation - turned into a checklist, with PANclear APG for GMP production and PANclear Octoxynol for research.
Read the paperSwitching off the REACH Trap
Six steps and a checklist for moving viral inactivation off octylphenol ethoxylates subject to REACH authorisation - with a 100 ml to 1000 L scale path on one grade.
Read the paperWFI Beyond - Elemental Stability
All 24 ICH Q3D elemental impurities still below limit at the 18-month stability point - in PET and PETG, 500 mL and 1000 mL.
Read the paper