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Discover the CPhI North America Learning Labs: Part TwoGareth Carpenter — 2 Aug 2021
Explore the series of Learning Labs at CPhI North America in which thought leaders at our exhibitors showcase their extensive knowledge on all areas of the pharma supply chain, offering industry insights across drug manufacturing, outsourcing, pharma ingredients, drug delivery and packaging.
Here in Part Two, we provide a taster of what some of them have to offer. All this knowledge is available to you at your desktop – all you need to do is register for the event here.
You can view Part One here.
Product Innovation: Packaging & Drug Delivery
Take a Breath: Selecting a Device for Inhaled Product Development
Geraldine Venthoye, Chief Scientific Officer & Executive Vice President – Product Development, Vectura discusses the factors affecting platform selection from early development to commercialisation, as well as strategies to accelerate an inhaled development programme.
“There really is a myriad of choices so how do we make the right informed choices for your product development?” she says. “We start off by understanding the Target Product Profile; this sets the foundational targets that you need to achieve. Around those targets will be critical success criteria, the most important of which are related to efficacy and safety and maybe improvements on quality of life.”
She adds that other key criteria include commercial and financial targets, and some of these may influence the choice of technology, depending on whether it is a high-value, low-volume product or vice versa.
“Understanding your market, your price points, cost of goods targets that you need to achieve and any aspect of differentiation or exclusivity or IP protection that you need to achieve may inform the device choices that you make,” she adds.
ASD-HIPROS – A new platform for quick and effective formulation screening for Amorphous Solid Dispersions by Spray Drying
Within this Learning Lab, Nuno Espinha, Marketing Analyst Specialist, Hovione introduces the company’s new formulation screening platform for amorphous solid dispersions by spray drying that integrates in silico computational models, formulation and analytical development.
“The pharmaceutical pipeline has become increasingly complex and challenging – most new drugs in the pipeline present low aqueous solubility and this is a challenge that needs to be solved,” he says, adding that this translates to low bioavailability due to limited absorption in the gastro-intestinal tract which in turn results in the need for increased time and investment towards finding an oral delivery solution for your drug.
“It is important to highlight that the correct choice of a platform is essential towards efficiently developing formulations that are effective in the end product,” he says.
Parenteral Packaging Selection Process for Drug Delivery Devices
In this presentation, Eugene Polini, Technical Key Account Manager, Datwyler Pharma Packaging USA introduces packaging components for cartridges used in drug delivery devices today and explores future trends that are emerging in the market.
“Datwyler’s portfolio is able to provide our customers a suitable solution for their cartridge applications, whether it is a dental product, an insulin or a high value biological drug intended for a pen injector or wearable injector,” he says. “We can provide you with the components meeting your requirements in a ready-to-sterilise or ready-to-use format.”
Product Innovation: Innovation in Bioprocessing & Biomanufacturing
LucasPye Bio: A Top Innovative CDMO
In our final Learning Lab, Gervan Williams, Director, Product Development and Innovation, LucasPye Bio introduces his Pennsylvania-based company which offers bio-manufacturing services to life science entrepreneurs, small biopharmaceutical companies, and non-profit organizations that financially support new biologics discovered by the aforementioned entities.
“We are the only cGMP large-scale bioprocessing facility in the state of Pennsylvania and one of just seven US cGMP biologics CDMOs with the technical capabilities to bioprocess viral and gene vector molecules,” he says.
He adds that the company is one of three cGMP biologics CDMOs with viral and gene vector molecule bioprocessing capabilities via adherent cell manufacturing processes.
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