The Kilo Lab phase is an important foundation phase that can save tremendous costs in the long-run. Our Kilo Lab Facilities and Kilo Lab Services are one of the best in the industry and we ensure that the kilo lab phase ensures that manufacturing is a smoother, more efficient process.It helps the sponsor and our team to be sure we understand the steps involved, the parameters, and also even the impurities that get produced as we scale up to get ready for GMP manufacturing.
At GVK BIO, the kilo lab phase is so important that we are reluctant to work with sponsors that won’t make the short-term investment. We have found that the kilo lab can pay off big time in minimizing the possibilities of set-backs that can delay the project and increase the costs.
Kilo Lab Facilities are specifically designed and equipped for safely conducting phosgenation and related reactions. Specialized analytical skills support new product research and process development. GVK BIO’s R&D and Process Engineering staff are experts in identifying the appropriate chemistry and most advantageous production scheme needed to bring your ideas to life. To help ensure a seamless transition from your development lab or manufacturing site to ours, we work closely with your technical staff during the development and scale-up stages of the project. GVK BIO has fully staffed and modern Kilo Lab facilities in which all new processes are vetted before being transitioned to the manufacturing facility. By going through this critical stage, better estimates of costs and technical hurdles can be determined.
Our scientists utilize this lab for complex chemistry and process development requirements with the goal of producing large scale reactions and kilo scale batches of synthetic molecules for preclinical testing, CMC stability and characterization analysis.
Analytical equipment includes liquid and gas chromatographs, ultraviolet and infrared spectrophotometers, potentiometric titrators and an atomic absorption spectrometer.
- Carlisle glove box synthesis isolator – Hastelloy C filter and contained tray drying
- 100 liter glass reactor in Howorth full containment fume booth
- 100 liter Hastelloy C hydrogenation reactor (50 psi)
- Broad processing temperature range – (-)80ºC to (+)200ºC
- Certified to handle compounds down to 0.10 ug/m³ – SafeBridge Category 4 capable
- Kilo-scale non-cGMP custom synthesis
Services include new product synthesis, process development, lab-scale production and the development of analytical procedures. GVK BIO is experienced in chemical research, and process development leading to laboratory, pilot plant and full-scale production. Expertise, flexibility and resources are available to produce a wide range of specialty chemicals.
Why is the Kilo Lab Phase Important During Drug Development?
The kilo lab phase is important because it can often minimize unpleasant surprises when the process is tested in the pilot plant for the first time and provides the ability to produce relatively small amounts (1 – 20Kg) of non-GMP compounds to address customers’ needs in a timely manner.
In some cases, clients don’t want to pay for 1 or more runs in the kilo lab facility, but we feel it is an important step that can actually save time and money.
Kilo labs are a cost-effective step to prove the substance can scale.
In the kilo lab, you can produce a first kilo to make sure that everything works as expected. Kilo labs offer the ability to mimic plant conditions to ensure, for example, that the desired polymorph of the API is obtained – but the benefit is that because it’s non-GMP, it limits the expense. Also, keep in mind: you want to get this phase right because it takes more time and money if you go directly to GMP manufacturing and have to start over again at the Optimization Phase. Beyond the cost, there is also the time delays since equipment, personnel and raw materials have to be scheduled again.
It’s much less expensive to discover your substance doesn’t scale up in a kilo lab than during cGMP manufacturing.
Because FDA requirements include the necessary paperwork and compliance efforts as well as the preparation for possible inspections, GMP manufacturing is much more expensive. You can chew up tremendous resources if you find out during cGMP that the process does not scale up.
Making it through the kilo lab once does not guarantee success once you start the scale up or manufacturing phase.
In fact, at GVK BIO, we run the process in the kilo lab facility three times to make sure the chemistry works and to collect the appropriate information.
The goal is to work through the three times as quickly as possible to get the substance into GMP manufacturing. If it doesn’t work after three times in the kilo lab facility, we look for the issues, which may entail going back to the Optimization Phase.
One of the most important parts of the work in a kilo lab is the tech transfer at the end of the process.
Once we demonstrate that there are no issues during the scaling up phase in the kilo lab, we assign a chemical engineer to work with the kilo lab team in order to prepare a master batch record.
The step-by-step details of the process that will go into GMP manufacturing. Even if everything does work, if you’re going to make changes to the process, this is the time to do it.
This part is very important because this is the start of the documentation that will be included in any potential filings, including the Drug Master Files (DMFs) and any Investigational New Drug Applications (INDs).
How Can GVK BIO though its Kilo Lab Services?
GVK BIO can help with early stage hit confirmation and expansion by:
- Lead optimization through chemical modification of hit structures leading to a larger pool of active compounds
- Supplying milligram to gram quantities of lead compounds for primary screening studies
- Manufacturing gram scale quantities for primary screening confirmation, dose-response curves, orthogonal testing and secondary screenings
- Evaluation of synthetic route feasibility and detailed cost estimation for each hit
- Working with your legal team to evaluate freedom to operate and patentability
GVK BIO can continue to provide kilo lab services beyond lead optimization by:
- Providing route selection and optimization services
- cGMP synthesis of targets for pre-clinical and clinical studies
- Documenting process design work for regulatory filings
- Performing validation batches and writing associated validation reports
- Conducting stability and forced degradation studies
- Co-developing stability-indicating analytical methods
- Identifying and synthesizing process impurities and degradants
- Manufacturing your NME for delivery to your selected forumlator
- Providing tech transfer support if a larger manufacturing facility is required
Leverage our expert solutions to achieve faster cycle times and increase process scale efficiencies and yields. We provide integrated capabilities in discovery, development and manufacturing for seamless project transition.