ASKLEO 把 ISA-88 批次配方、过程分析与本地大模型合成一套可验证的控制系统：工艺专家用自然语言描述变更，系统生成配方、走审核、下发设备、全程留痕。不依赖外网，数据不出厂区。ASKLEO unifies ISA-88 batch recipes, process analytics and an on-premise LLM into one verifiable control system: experts describe a change in plain language; the system drafts the recipe, routes it for approval, runs it on equipment and records everything. No internet dependency, no data leaving site.
生物药工艺的瓶颈往往不在设备，而在知识的传递方式：配方靠文档、变更靠会议、批次数据靠事后补录。ASKLEO 换掉的是这条链路。The bottleneck in bioprocess is rarely the equipment — it is how knowledge travels: recipes in documents, changes in meetings, batch data recorded after the fact. ASKLEO replaces that chain.
同一工艺换一个项目就要重写一遍，参数口径不一致，新人也接不住。Every new project rewrites the same process; parameter definitions drift; new staff cannot take over.
ISA-88 三层配方可复用、可版本化、可追溯ISA-88 three-layer recipes: reusable, versioned, traceable工艺优化以周为单位排队，验证又要重跑一遍。Process improvements queue for weeks, and validation has to be redone each time.
自然语言描述变更，系统生成可审核的配方差量Describe the change in words; the system drafts a reviewable diff谁在什么时候改了哪一个参数、依据哪一版，事后只能靠邮件与截图拼。Who changed which parameter, when, and against which version — reconstructed from emails and screenshots.
链式审计追踪，电子记录随时可导出Chained audit trail; e-records exportable at any time每项能力单独可讲，但只有连起来才成立：能生成、能审核、能执行、能看见、能举证。Each capability stands alone, but only together do they work: author, approve, execute, observe, evidence.
用中文描述工艺意图，ASKLEO 生成 ISA-88 结构配方；规则引擎逐条校验量程、单位与安全联锁，大模型只提议，不直接下发。Describe intent in plain language; ASKLEO produces a structured ISA-88 recipe. A rule engine checks ranges, units and interlocks — the model proposes, it never actuates.
每次变更产生新版本与差量，按角色走审核；未审核的配方无法启动批次。Every change creates a new version and diff, routed by role; unapproved recipes cannot start a batch.
按步骤执行、异常中断可恢复；多台设备并行排程，甘特视图看整条产线。Step-wise execution with resumable interruptions; parallel scheduling across units with a line-level Gantt view.
趋势曲线、工艺流程图与报警同屏；操作员看到的是设备当前状态，不是五分钟前的报表。Trends, process flow diagram and alarms on one screen — operators see the current state, not a five-minute-old report.
过程能力 Cpk/Ppk、参数设计空间评估，把工艺理解沉淀成可复用的判据。Process capability (Cpk/Ppk) and design-space evaluation, turning process understanding into reusable criteria.
HMAC-SHA256 链式记录，任何改动留痕；批次结束自动生成报告，附原始数据。HMAC-SHA256 chained records for every change; batch reports generated automatically with raw data attached.
ASKLEO 负责把配方落到设备、把过程留成记录；ASKLEO-Agent 负责实验数据、配方、技术转移与工艺数字孪生——前者管“做”，后者管“怎么定”。两者都可完全本地部署，且配方可互相流转。ASKLEO turns recipes into machine action and process into records; ASKLEO-Agent owns experiment data, recipes, tech transfer and the process digital twin — one runs the plant, the other decides what to run. Both run fully on-premise, and recipes flow between them.
ASKLEO 是星漩自研的生物药过程控制平台，覆盖配方、审核、执行、监控与记录五个环节。它不追求把所有设备绑成一个品牌，而是让不同厂牌的设备在同一套配方与记录体系下运行。ASKLEO is our in-house bioprocess control platform covering recipe, review, execution, monitoring and records. It does not lock equipment into one brand — it makes equipment from different vendors run under one recipe and record system.
| 配方标准Recipe standard | ISA-88 |
|---|---|
| 记录合规Records | 21 CFR Part 11 |
| 设备接口Equipment I/O | S7 / Modbus RTU·TCP |
| 部署形态Deployment | 厂区服务器 / 工控机 |
| 网络要求Network | 可完全离线 |
| 数据留存Data residency | 不出厂区 |
自然语言或模板 → ISA-88 配方草案Language or template → ISA-88 draft
差量比对 + 角色审批 + 电子签名Diff, role approval, e-signature
参数下发、联锁校验、批次开始Parameter download, interlock check, batch start
趋势、PFD、报警、偏差记录Trends, PFD, alarms, deviations
批次报告 + 原始数据 + 审计链路Batch report, raw data, audit chain
ASKLEO-Agent 把工艺从“老师傅的经验”变成可计算的对象：实验数据统一结构化并做统计分析，结论直接生成或修订配方，配方先进数字孪生试算，再打包成技术转移文件交付生产。文档检索与问答是它的基础能力，不是卖点。ASKLEO-Agent turns process know-how into computable objects: experiment data is structured and analysed, conclusions become or revise recipes, recipes are first tried in a digital twin, then packed as a tech-transfer package for manufacturing. Document retrieval and chat are its baseline, not the pitch.
| 产品定位Category | 工艺数据与知识平台 |
|---|---|
| 特色模块Signature modules | 实验数据 / 配方 / 技术转移 / 数字孪生 |
| 数据接入Data sources | 实验记录 / 设备数据 / 检测结果 |
| 与 ASKLEOWith ASKLEO | 配方可下发执行 |
| 合规框架Framework | ICH Q10 / 21 CFR Part 11 |
| 部署形态Deployment | 厂区服务器 / 离线 |
实验数据与检测结果结构化入库Experiment and assay data structured
批次间比对、统计分析与结论Batch comparison, statistics, conclusions
由结论生成或修订配方，走审核Recipes drafted or revised, routed for review
孪生模型试算参数组合Twin runs parameter combinations
转移包交付生产，执行留痕Transfer package to manufacturing, fully traced
控制侧与知识侧共用同一套配方模型、同一个数字孪生、同一条审计链，差别只在应用面。其中三项核心方法已在中国专利公报公开。Control and knowledge share one recipe model, one digital twin and one audit chain — only the application surface differs. Three of its core methods are already published in the Chinese patent gazette.
操作员一句话就能改参数，指令 500 ms 内响应；参数越限前即被拦下，不用人一直盯屏。模型跑在普通工控机上，私有化部署不需要 GPU 集群。Operators change parameters by speaking, with a response inside 500 ms, and out-of-range values are stopped before they are sent. The model runs on an ordinary industrial PC — no GPU cluster needed on site.
过程漂移在报警之前就被识别，并按风险分四级处置：提示、纠正、保护、快停。人工介入次数下降，高风险场景仍能自动兜底。Drift is caught before any alarm fires and handled at four escalating levels — notify, correct, protect, stop — so operators intervene less while high-risk events are still covered automatically.
层析峰形与柱压可以提前预测，少做试批、少做离线标定；模型在 CPU 上运行，可直接部署到现场控制器。Peak shape and column pressure are predicted in advance, cutting trial runs and offline calibration; the model runs on a CPU and deploys straight to a site controller.
带签名的扩展包才能装载，可回滚、有台账。Only signed packs load — with rollback and a ledger.
急停直连继电器，物理断电 <1 ms，不过软件。E-stop cuts power through a relay in under 1 ms, bypassing software.
HMAC-SHA256 链式留痕，可按批次导出。HMAC-SHA256 chained records, exportable per batch.
没有依据就不回答，回答必带出处。No basis, no answer — every reply cites its source.
以上为已公开的发明专利申请，公布日与申请号取自专利公报与受理通知书；技术方案以公开文本为准。These are published invention applications; publication dates and numbers come from the gazette and CNIPA notices. The published documents are authoritative.
谁改了什么、为什么改、依据哪一版——在 ASKLEO 里都是系统事实，不是事后整理的说明。Who changed what, why, and against which version are system facts in ASKLEO — not narratives assembled afterwards.
配方按单元 / 操作 / 阶段组织，工艺与设备解耦，换设备不必重写工艺。Recipes by unit / operation / phase; process decoupled from equipment, so changing hardware does not rewrite the process.
唯一账号、权限矩阵、链式审计追踪、电子签名路径。Unique accounts, permission matrix, chained audit trail, e-signature paths.
按风险分级交付：URS / FS / DS、测试脚本与追溯矩阵。Risk-based delivery: URS / FS / DS, test scripts and traceability matrix.
原始记录不可覆盖，时间戳与操作人完整留存，可导出举证。Raw records are non-overwritable; timestamps and operators retained and exportable.
ASKLEO 是控制层，下面接什么设备取决于工艺。以下是当前在用的三类场景。ASKLEO is the control layer; what sits beneath it depends on the process. Three current scenarios:
连续流碱裂解 + 澄清 + 超滤 + 层析的配方化执行，桌面型设备由 PC 端远程操作。Recipe-driven continuous lysis, clarification, UF and chromatography; benchtop hardware operated remotely from a PC.
从质粒制备到 LNP 包封的多设备串联调度，工序间参数与记录打通。Multi-unit orchestration from plasmid prep to LNP encapsulation, with parameters and records linked across steps.
同一车间多台设备按甘特排程并行运行，配方与批次记录统一归档。Multiple units in one suite scheduled in parallel, with recipes and batch records archived in one place.
实验室工艺连同偏差与结论打包转移给生产，接收端按同一份依据执行，参数不再靠邮件口头传递。Lab processes transferred to manufacturing together with deviations and conclusions; the receiving site works from one shared basis instead of email and folklore.
装备只是执行端。星漩同时做设备与软件，所以这套控制层可以按你的现有设备改造接入，不要求整线更换。Equipment is only the execution end. Because we build both hardware and software, ASKLEO can be retrofitted onto your existing units — no full-line replacement required.
星漩数据科技（苏州）有限公司专注细胞与基因治疗领域的工艺自动化与过程控制软件。我们把工艺专家的经验写成配方，把配方落到设备动作，再把过程数据变成可申报的记录。ASTRAWHIRL DATA TECHNOLOGY (SUZHOU) CO., LTD. builds process automation and control software for cell and gene therapy. We turn process know-how into recipes, recipes into machine action, and process data into filing-grade records.
团队同时具备 CGT 工艺、自动化与软件工程背景。三项已公开的发明专利，分别覆盖设备自然语言控制、过程多级自动干预与层析数字孪生。The team combines CGT process, automation and software engineering. Three published invention patents cover natural-language equipment control, multi-level process intervention and chromatography digital twins.
无论是新建产线还是给现有设备加一层控制，都可以先聊一次。通常 1 个工作日内回复。Whether it is a new line or a control layer on existing equipment, start with a call. We usually reply within one business day.
试用为受邀制：提交申请，审核通过后开通演示账号。Trials are invitation-based: submit an application and a demo account is provisioned after review. 提交试用申请 →Submit a trial request →
本入口面向受邀客户。提交后 1–2 个工作日内评估并联系开通，试用为只读演示环境。This entry is for invited customers. Applications are reviewed within 1–2 business days; the trial is a read-only demo environment.