GMP Manufacturing Solutions for Today’s Challenges
From problematic tech transfers to vulnerable supply chains, the challenges of GMP manufacturing are more magnified than ever. At VLE, we deliver pragmatic solutions all along your CMC journey—all under one roof.
Now, nothing stands in the way of your medicine.
Process Development
Based on your process needs, we call on our specialized process development arm, APC, to adapt and refine your existing process in direct collaboration with our GMP team. Wherever you are in your process development, we’ll work to perfect it.
Tech Transfer & Scale-Up
We are making arduous tech transfers a thing of the past through our phase-appropriate knowledge management framework known as iTRANSFER. This novel approach reins in and streamlines process development data, reports, risk assessments and more, bolstered by iACHIEVE, our advanced digital CMC workflow platform that provides unprecedented project management and validation master planning abilities, while creating a governance process to ensure resources & budgets are smartly deployed.
GMP Clinical Manufacturing
From making small test batches in APC’s pre-GMP pilot plant to more robust, clinical manufacturing in our state-of-the-art GMP facilities, our world-class process development scientists and GMP teams will solve any and all clinical GMP manufacturing needs across modalities including Oncolytic Vectors, Cell & Gene Therapies, mRNA, and Monoclonal Antibodies.
GMP QC Analytical Services
We have extensive in-house experience in analytical and bio-analytical quality control, managing a range of testing to support your process including raw material conformance, sample management, in-process testing and at-line testing, while ensuring GMP compliance. We’ll collaborate with you to determine what tests are needed to properly evaluate your product and align it with relevant regulations.
GMP Supply Chain Services
Don’t let supply chain issues derail all the progress you’ve made. Our Supply Chain Centre of Excellence will oversee your end-to-end supply chain from raw materials to distribution while managing day-to-day GMP requirements like sourcing, procurement, inventory and storage management, supplier management, logistics, customs and exporting.
QP & Regulatory Services
Successful releasing your product in the EU, UK and worldwide requires expertly qualified persons (QPs) and a regulatory team that can develop a strategy to ensure key milestones are met on your CMC pathway to clinical and commercial realization. VLE has you covered with expert guidance to support you throughout your product and process life-cycles.
Business Services
As an extension of your internal team, we partner with you to support your business across project management, commercial, finance and legal needs and requirements. You’ll have total clarity with iACHIEVE, our collaborative data management platform for maintaining active communication and robust digital documentation, turning painstaking tech transfers into effortless onramps to manufacturing and regulatory review. We also offer an Operational Excellence team that focuses on constantly optimizing your entire GMP manufacturing process.
Based on your process needs, we call on our specialized process development arm, APC, to adapt and refine your existing process in direct collaboration with our GMP team. Wherever you are in your process development, we’ll work to perfect it.
We are making arduous tech transfers a thing of the past through our phase-appropriate knowledge management framework known as iTRANSFER. This novel approach reins in and streamlines process development data, reports, risk assessments and more, bolstered by iACHIEVE, our advanced digital CMC workflow platform that provides unprecedented project management and validation master planning abilities, while creating a governance process to ensure resources & budgets are smartly deployed.
From making small test batches in APC’s pre-GMP pilot plant to more robust, clinical manufacturing in our state-of-the-art GMP facilities, our world-class process development scientists and GMP teams will solve any and all clinical GMP manufacturing needs across modalities including Oncolytic Vectors, Cell & Gene Therapies, mRNA, and Monoclonal Antibodies.
We have extensive in-house experience in analytical and bio-analytical quality control, managing a range of testing to support your process including raw material conformance, sample management, in-process testing and at-line testing, while ensuring GMP compliance. We’ll collaborate with you to determine what tests are needed to properly evaluate your product and align it with relevant regulations.
Don’t let supply chain issues derail all the progress you’ve made. Our Supply Chain Centre of Excellence will oversee your end-to-end supply chain from raw materials to distribution while managing day-to-day GMP requirements like sourcing, procurement, inventory and storage management, supplier management, logistics, customs and exporting.
Successful releasing your product in the EU, UK and worldwide requires expertly qualified persons (QPs) and a regulatory team that can develop a strategy to ensure key milestones are met on your CMC pathway to clinical and commercial realization. VLE has you covered with expert guidance to support you throughout your product and process life-cycles.
As an extension of your internal team, we partner with you to support your business across project management, commercial, finance and legal needs and requirements. You’ll have total clarity with iACHIEVE, our collaborative data management platform for maintaining active communication and robust digital documentation, turning painstaking tech transfers into effortless onramps to manufacturing and regulatory review. We also offer an Operational Excellence team that focuses on constantly optimizing your entire GMP manufacturing process.
Next Generation GMP
VLE represents the future of GMP manufacturing with unprecedented scientific collaboration from process development to manufacturing, coupled with a flexible facility that means never having to wait your turn for tanks.
Your Process, Perfected
Is your process a little raw? Maybe it needs some fine tuning? Or perhaps it’s ready to go. Whichever the case, our scientists and engineers will ensure that it’s quickly optimized for tech transfer and manufacturing.
All Under One Roof
With VLE’s GMP manufacturing, supply chain management and regulatory services in the same location as process development powerhouse APC, everything you need is under one roof rather than dispersed around the globe.
Redefining Tech Transfer
At VLE, tech transfers are not business as usual. Once your process development is digitized in iAchieve, our comprehensive workflow management tool, we leverage the deep knowledge and expertise of our in-house process scientists for a seamless transition to scale-up and manufacturing, and beyond.
A Better Business Model
We don’t execute flawed processes just to fill tanks. Instead, we cater to the specific needs of your medicine and we partner with you to build customized workflows, assemble targeted subject matter experts and ensure pragmatic solutions. We create and implement optimal processes that expedite the delivery of medicines, getting them into the hands of patients faster, at a lower cost to you.
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