Japan guides
Japan's rules for overseas manufacturers and suppliers
Each guide answers one question a QA, regulatory or site team outside Japan meets when a Japanese partner gets in touch: who files what, which document PMDA reads first, and what to ask before you agree to anything. Every claim maps to a source listed at the end of the guide.
Japan regulation
What overseas manufacturers, CDMOs and suppliers need to know before they make or sell for the Japanese market, built from PMDA and MHLW sources.
Japan regulationForeign manufacturer accreditation in Japan: who needs itJapan's Accreditation of Foreign Manufacturers (PMD Act Art. 13-3): who needs it, the 5 categories, 5-year renewal and how it differs from GMP inspection.Updated Japan regulationJapan GMP Ordinance vs 21 CFR 211 and EU GMP: the gapsJapan's GMP Ministerial Ordinance tracks PIC/S. Where its 2021 revision differs for foreign sites: approval compliance, a separate QA unit and MAH alerts.Updated Japan regulationJapan MAH explained: license, three officers, DMAH optionsOnly a licensed MAH in Japan can market a drug there. License types, the 3 officers, GQP and GVP, foreign special approval, and how to choose a route.Updated Japan regulationJapan Master File (MF) and the in-country caretakerHow Japan's Master File protects API, excipient and cell-material know-how, what the in-country caretaker does, and why MF changes go to the MAH first.Updated Japan regulationJapan Standard for Biological Ingredients: a supplier guideJapan's Standard for Biological Ingredients covers animal and human material in media and reagents. The 2026 ruminant change and what to document.Updated Japan regulationPartial change vs minor change in Japan: which route appliesJapan splits drug post-approval changes into prior-approval partial changes and minor change notices due in 30 days. What decides it, and 3 newer routes.Updated Japan regulationPMDA GMP inspection of overseas sites: what to preparePMDA inspects foreign drug sites at approval and every 5 years. Who applies, how desk review vs on-site is decided, and what to send first.Updated Japan regulationYakkan Shomei: Japan import confirmation for drug samplesJapan replaced the Yakkan Shomei with import confirmation in 2020. When R&D samples and trial drugs need one, how to apply, and what suppliers must send.Updated
Japan CDMOs and suppliers
ADC supply chainADC payload and linker supply: where capacity runs shortADC schedules are set by payload and linker supply, not the antibody. Why containment forces dedicated suites, and what to ask a CDMO before you commit.Updated CDMO contractsCDMO capacity reservation: what a long-term contract costsSamsung Biologics' 7.5-year, $262 million deal and Vir's take-or-pay terms show what reserving CDMO capacity costs, and how to read headline order totals.Updated Chiral HPLC columnsCoated vs immobilized chiral HPLC columns: how to chooseCHIRALPAK AD-H and IA share one selector but not solvent tolerance. How to choose coated or immobilized chiral columns, what ruins them, and a checklist.Updated ADC conjugationHow to choose ADC DAR: why more drug is not always betterA 2004 study found DAR 8 cleared 3x faster than DAR 4 with no extra antitumor effect. How lysine, cysteine and site-specific conjugation set the DAR.Updated Insulin purificationInsulin purification: IEX, RP-HPLC and zinc crystallizationBinding capacity fell to under a third with another test protein. How IEX and RP-HPLC separate insulin look-alikes, and why zinc crystals finish the job.Updated Single-use vs stainlessSingle-use vs stainless steel: how to choose for biologicsVessel size no longer decides single-use vs stainless. Cost shape, the work that replaces cleaning, parts with no second source, and a selection checklist.Updated
Process guides
Gene therapy process guideAAV manufacturing process: transfection to empty capsidsHow AAV vectors are made: HEK293 triple transfection, harvest, affinity capture, empty/full separation and sterile filtration, plus what to ask a CDMO.Updated Cell therapy process guideCAR-T manufacturing process: apheresis to release testingAutologous CAR-T manufacturing step by step: apheresis, activation, gene transfer, expansion, freezing, release testing, and where batches tend to fail.Updated Cell therapy vector choiceCAR-T vector choice: lentivirus vs gamma-retrovirusLentivirus or gamma-retrovirus for CAR-T? Compare dividing vs resting cells, insertional mutagenesis by design, CDMO timelines and non-viral pitfalls.Updated Nucleic acid process guidemRNA-LNP manufacturing process: from IVT to sterile fillmRNA-LNP manufacturing step by step: IVT, capping, purification, LNP formation, TFF and aseptic filling, plus the quality attribute each step carries.Updated Cell therapy process guideMSC manufacturing: cell banks, passages and potency assaysKeeping MSC lots consistent: donor and serum effects, ISCT criteria, the Ryoncil potency-assay lesson, MCB/WCB cell banks and passage limits.Updated Small molecule process guideSmall-molecule API process: synthesis to crystallizationSmall-molecule API manufacturing step by step: starting materials, multistep reactions, workup, crystallization, drying, milling and ICH Q3 impurities.Updated
Cell therapy
Tissue engineeringCell sheet engineering: why cornea worked and heart did notA cell sheet is an approved cornea product, but HeartSheet missed full approval in 2024. How sheets work, and how scaffolds and organoids compare.Updated Release testingCell therapy release testing: rapid sterility and mycoplasmaCell therapy may be dosed before final sterility results. Why 14- and 28-day tests do not fit, the rapid alternatives, and what to do on a late positive.Updated Closed-system manufacturingClosed-system cell manufacturing: what counts as closedA closed system also frees people and cleanroom space. Integrated devices, connected containers and open steps compared, plus checks to run before you buy.Updated High-content imagingHigh-content imaging system selection: reproducibility firstOpera Phenix, ImageXpress and CellVoyager compared on what comes first: confocal or widefield, lenses, plates and Cell Painting batch effects.Updated iPSC differentiation and QCiPSC differentiation and QC: why the same protocol variesWhat an iPSC differentiation protocol fixes and what still varies: line effects, lactate purification, residual cells down to 0.002%, allogeneic stocks.Updated Regeneration-inducing drugsRegeneration-inducing drugs: redasemtide vs cell therapyRedasemtide calls a patient's own stem cells to an injury instead of transplanting cells. How it differs from cell therapy, plus its 2026 stroke result.Updated
Downstream processing
Antibody purityAntibody purity: aggregates, fragments, SEC and CE-SDSAntibody purity is the share of aggregates and fragments. Why a 2013 Thymoglobuline batch was recalled, what SEC and CE-SDS each miss, where clumps form.Updated Resin selectionHow to choose a chromatography resin for mAb purificationProtein A capacity drops from about 80 to 40 mg/mL as residence time falls from 6 to 2 minutes. How to pick resins by impurity, cycles and cost.Updated Ion exchange resinsIon exchange resin selection: reading CEX and AEX capacityOne resin binds 175 mg/mL of BSA but 49 mg/mL of thyroglobulin. How to read CEX and AEX capacity, then choose base, bead size, ligand and cleaning life.Updated Planova virus filtersPlanova virus filter grades: 15N, 20N, 35N, BioEX and FG1Choosing among Asahi Kasei's Planova 15N, 20N, 35N, BioEX and FG1 virus filters: pressure and interruption effects, prefilters, integrity tests.Updated Protein A resinProtein A resin selection: alkaline tolerance and elution pHWeak NaOH cleaning can cut Protein A capacity faster than strong. How alkaline tolerance, elution pH and DBC conditions drive resin cost and quality.Updated Virus filter membranesVirus filter selection: membrane material, structure and LRVVirus filters with the same 20 nm pore size and 4-log claim still differ: cellulose, PVDF and PES membranes, pump-stop retention, clogging, reading LRV.Updated
Quality control
Quality control · BioburdenBioburden monitoring: test methods and pre-filtration limitsBioburden is the live microbial count before sterilization or sterile filtration. Test methods, where 10 CFU/100 mL comes from, alert and action levels.Updated Quality control · EndotoxinEndotoxin testing in practice: limits, MVD and interferenceA sample can hide the endotoxin you spiked into it, as low endotoxin recovery (LER) shows. How to set limits, MVD, spot interference and choose LAL or rFC.Updated Quality control · MycoplasmaMycoplasma testing: culture, indicator cell and NAT comparedMycoplasma clouds no medium and can pass 0.2 µm filters. Culture vs indicator cell vs NAT, what Ph. Eur. 2.6.7 changed in April 2026, and how to choose.Updated Quality control · rFCrFC vs LAL endotoxin testing: what to check before switchingrFC replaces horseshoe crab LAL with a recombinant protein. How LAL, rFC and rCR differ, why labs switch, what to compare on your product, common mistakes.Updated Quality control · SterilitySterility testing and RMM: what a negative result provesA negative sterility test does not prove a sterile lot: 1 bad unit in 1,000 gives only a 2% chance of a positive in 20 units. Limits, positives and RMM.Updated Quality control · WaterWater for injection (WFI): grades, specs and loop designWFI vs purified water vs pure steam: how WFI is made by distillation or membranes, where USP, Ph. Eur. and the JP differ, and how to design the loop.Updated