Case study:
Humacyte Chooses Access Orchestrate To Help Manufacture A Groundbreaking Biopharma Innovation
Access Orchestrate was ‘head and shoulders above’ when it came to choosing advanced planning manufacturing software.
Business size
Medium
Industry
Biopharmaceuticals
Product
Access Orchestrate
Challenge
With plans to scale-up production of its innovative Human Acellular Vessel (HAV) product, Humacyte’s complex planning schedule was kept together with Excel and Outlook.
Approach
Humacyte chose Orchestrate Advanced Planning Software to tackle bringing the product out of clinical trials and towards commercial use.
Results
Humacyte now has a system ready to handle the months-long manufacturing process of a live product, with no concerns over human error leading to financial loss.
Based in North Carolina, Humacyte’s aim is to transform medicine with its state-of-the-art Human Acellular Vessel (HAV) product.
This bioengineered human tissue, which grows in a tube shape in controlled conditions, has endless use-cases, from AV access for dialysis patients through to saving those who have experienced vascular trauma.
Resistant to infection with an 18-month shelf life, the HAV is an innovation which will transform medicine as we know it. Humacyte’s technology has only touched the surface of its potential, with research now testing its ability to help type-1 diabetes patients and even grow organs for transplant.
Humacyte’s Director of Manufacturing, Matt Panning, spoke to Access about how Humacyte’s HAV innovation has already been used to save limbs of frontline soldiers in the War on Ukraine.
Advanced Planning Beyond Excel
Humacyte’s innovative products demand a complex manufacturing process which requires precise timings and multiple planned stages. For a completely new product to the market (Humacyte was the first product to receive the Food & Drug Administration’s Regenerative Medicine Advanced Therapy (RMAT) designation), a compliant process needed to be developed from scratch.
While in its start-up stage, Humacyte achieved this through using the Microsoft suite, including complex Excel spreadsheets and scheduling via Outlook.
Matt Panning explains the planning process Humacyte applied during its lower-scale, clinical phase, and why the need for Orchestrate became apparent.
Read more about why planning production using Excel may be hurting your business.
Why Access Orchestrate Is The Perfect Fit For Humacyte’s Plans To Scale Up
Manufacturing a biologic product requires an exceptionally precise planning process to ensure the regulated device is both high quality and validated. Any errors lead to the loss of a batch – in some cases leading to a six-figure loss.
Humacyte’s production process is also cross-functional – with many groups involved in different stages of production.
When scaling up, biologic products require Advanced Planning & Scheduling Software in order to retain control and visibility across a project. Access Orchestrate’s advanced features help pharma companies like Humacyte make their production process as efficient as possible – with scheduling conflicts and constraints identified weeks in advance.
Matt Panning explains the planning precision needed for biologics production.
The Access Group’s Customer Support & Industry Expertise
Access Orchestrate is rich with features required by biopharma companies to successfully optimise batches, such as advanced ‘what-if?’ analysis and tracking multiple batches in a single system.
Because of our experience within the industry, The Access Group was able to understand the specific needs of a groundbreaking product like Humacyte and provide the advanced solution needed.
We achieved this through on-site visits to North Carolina and support from our consultants who have a deep knowledge of the industry and its requirements.
I also think the ‘What if’ analysis was honestly the icing on the cake for us. It wasn’t something we had really expected to get out of this software, but when we saw that functionality it was an extra star for us.
Matt Panning explains why The Access Group experience put us ‘head and shoulders’ above other vendors during Humacyte’s discovery process.
Access Orchestrate’s Advanced Planning Software for manufacturing brings a myriad of benefits to pharmaceutical companies handling a complicated manufacturing process. Advanced planning helps increase capacity, control costs, improve communication and reduce downtime.
