'Green Circle' Partners - Technology & Manufacturing
This is an elite union of partners in botanical technology and manufacturing picked for their reliability, quality and innovation. This group has been created after years of developing new botanical processes to rigorously meet pharmaceutical standards.
Unfortunately, the industry is rife with inferior brands and equipment suppliers that are unsuitable for serious drug development. This manifests in design flaws, misleading marketing, poor customer service, inefficient solutions, regulatory untenable approaches etc. Companies sometimes talk a good game but often costly issues arise when it's too late, the investment has been made. These mistakes can be killer to operating a profitable-efficient business.
Oast House Botancials respects equipment suppliers that go the extra mile not just in customer support but in intelligent design. The Green Circle encapsulates technologies from horticulture to formulation. It's an expanding project growing at an appropriate pace to ensure the highest of quality and vetting.
Technologies often require somewhat bespoke solutions to fit a clients need. The time/money lost trying to get 'off-the-shelf' equipment to perform well in situ is often overlooked. In our experience getting technology up and running to a point a customer is completely happy can take years. This is where external guidance that we provide can help create a bespoke solution that can pay huge dividends. This kind of work is achieved through the assistance in user specification requirement writing and mediation with the equipment supplier to reinforce the buyers needs through industry hardened insight.
To summarise we use experience in the area of process science within the botanical industry and extensive contacts to provide the most appropriate technological solutions that benefits client's needs. Additional services can be provided that support technology integration through URSs, DQ/IQ/OQ/PQ, RAs, SOPs, technical support, etc. In practice, this saves botanical drug businesses vast sums of money by giving a competitive edge through efficiency and innovation.
Process Optimisation - Statistical Design
Quality-by-Design and process optimisation are the backbone of a successful manufacturing business. At large scale, process improvement percentage points can have profound impacts on cost and time. To ensure you are squeezing the most out of your process you will want to obtain accurate and reliable models. You will need to communicate the process understanding and be able to draw clear conclusions. This can be a challenge when data is multivariate and variables interact with each other giving deeply complex models. This requires specialist software to be used to compute the statistics iteractively and produce the visual models.
QbD methodology and process understanding is not solely for increasing efficiency through resource savings/increased yield. It is a way of proving to regulators that you understand your process and the sources of variation. It enables you to confidently talk to the regulators and show you have control over the quality of the output.
'Fail to plan, plan to fail', planning is a crucial part of the process. Often lots of data can be missed or corrupted by improper planning and foresight. DOE can be an art requiring a bespoke design for each individual project and objective.
Oast House Botanicals is here to assist at all points in the development process. The value of experience is immense. To give an example Oast House Botanicals is yet to have seen a supercritical fluid extraction model that approaches the design space efficiently; academic and industrial models inefficiently explore the design space due to a lack of simultaneous mastery of the fundamentals of DOE and supercritical fluid extraction. Oast House Botanicals is here to explain why and guide you on your path of botanical process development.
Phytochemical Profile Design
Phytochemistry is what makes your product special. Every pharmaceutical company should understand the fear of late stage clinical failure. Contemporary drug discovery and development courses hammer in the importance of avoiding failure late in the process. Botanical drug discovery should be no different. It should be underwritten by appropriate levels of pre-clinical validation so that the business risk is minimised. Less than ten FDA approved botanical drugs exist.
Perhaps botanical drugs are thought of a safe bet; they've been around for years. Or perhaps the whip is being cracked to get to market as soon as possible thus corners have to be cut. The pharmaceutical sector has overtime learnt the hard way the pain of late stage clinical failure. Leaving parts of the botanical drug profile to randomness and not rationalised precision, is rolling the dice on the future of your company. The arguments for pushing a botanical drug to market before doing extensive evaluations are short-sighted and would seem out of place in a synthetic chemistry pipeline. If you are the accountable person for the failure of a botanical drug pipeline then you really want to avoid being over zealous.
Unfortunately, classically trained pharmaceutical scientists struggle to hit a round peg into a square hole due to a training deficit in how to apply their craft to a complex multicomponent drug substance.
Oast House Botanicals has a wealth of experience in navigating the FDA botanical drug guidelines and driving CMC discussions for tailoring synergistic multicomponent botanical profiles. We have predefined strategies and methodologies to help guide your pipeline. We have pragmatic knowledge of how to study the phytochemical diversity of any botanical material to rationalise a guided drug discovery strategy. Let us collaborate to derisk your pipeline and build you a best-in-class profile that will stand the test of time (and the regulator's inquisition). Let us give patients the best chance of responding and receive the best efficacy possible. We will aim to bring you up to speed and ensure you make strategic decisions in a logical manner.
Hands-On Support - Manpower
There is no substitute for boots on the ground. That is why Oast House Botanicals can provide a freelance Process Scientist to come to site and help run equipment. A competent talent pool can sometimes be hard to find. So if you need to boost your pratical lab manpower to accelerate project work please contact us and we may be able to help your needs. Maybe you need some extra battle-hardened insight into how to get the most out of your equipment in person.
Conversely the mire of bureaucracy might be holding you up and you require some assistance with bureaucratic back room activities involving documentation creating. It can add a lot of value getting an extra mind on these tasks especially from an experienced individual. To use an example, a good URS can save months (if not years) of commissioning work and Oast House Botanicals has a proven track record working with suppliers to turn an 'off-the-shelf' piece of kit to be a bespoke solution. However, sometimes it's challenging to have foresight of what could go wrong and what might hold up projects; that's when our experience is invaluable.
Innovation
The very fibre of Oast House Botanicals is about innovation. It is the heart and soul of modern business especially in crowded industries. It is key for any business to stand out and solve problems in a way that gives a competitive edge. Innovation is all too often forgotten in a business due to strict timelines and the founder of Oast House Botanicals knows this all to well.
Oast House Botanicals can work with partners providing options utilising knowledge of novel technology and also the hurdles that have to be overcome to achieve innovation. Oast House Botanicals can consult with you how to best integrate technology and build timetabled plans that you can deliver on. Oast House Botanicals can also help perform the research you need to underwrite a business case so that the innovative change is the obvious one.
Don't waste your's and the world's resources pursuing outdated methodologies and redundant technology. Work smarter not harder. Generally speaking the technology you know about is only a portion of what is out there. It is genuinely a long process to identifiy, validate and document technological solutions so partner up with us today.
Regulatory and Quality Coaching
Quality management systems (QMS), Chemistry Manufacturing and Control (CMC) and Regulatory Affairs are key building blocks that define the difference between an early stage biotech and a fully fledged pharmaceutical company.
Oast House Botanicals has experience in these areas and we are passionate about shaping early stage assets into more developed investigational medicinal products (IMPs) and Investigational New Drugs (INDs).
We won't rest until your asset is match fit for clinical trials and beyond.