The CPhI Podcast Series is your new monthly pharma soundbite, bringing you insights from across the global value chain. Through drug discovery and development to manufacturing and delivery, we’ll bring you impactful content to keep you informed on the latest trends, developments and opportunities in Pharma. Brought to you by the organisers of the CPhI and Pharmapack exhibitions, the series is an easy way to stay up to date on the issues which matter to your business. Tune in to hear from key industry stakeholders sharing easy-to-digest insights – the CPhI Podcast Series is your trusted voice in pharma.
Selecting the Right CDMO Outsourcing Partner
12:05Sponsors within the biopharmaceutical industry are increasingly turning to outsourcing for several reasons; remaining competitive and flexible within a quickly evolving sector, gaining access to manufacturing capacity and state-of-the-art equipment and scaling up to the commercial level are just three examples. With so many outsourcing options available, selecting the CDMO that is the right fit for any particular sponsor company can be a challenging task. We speak with Frank Ternes, Chief Commercial Officer and Filip Ringborg, Director Contract Management & Operations Development, at Recipharm on best practice when it comes to selecting the right fit for your outsourcing requirements and how strategic partnerships built on trust are fundamental to success.
The opportunities and challenges of providing fill and finish services for mRNA platforms
19:35mRNA (Messenger ribonucleuc acid) technology has been thrust into the limelight in recent months, with the platform proving to be the springboard for two approved vaccines against the SARS-CoV-2 virus. The complex science around mRNA is very different from that of small molecule traditional pharmaceuticals or traditional biologics such as monoclonal antibodies. This month we speak to Christy Eaton, Global SME, Sterile Drug Products, Pharma Services Group at Thermo Fisher Scientific about how CDMOs are providing their manufacturing and fill finish expertise to bring mRNA vaccines to market in as timely a fashion as possible.
The distinction of drugs vs cosmetics from a regulatory perspective
21:40As more and more companies operating in the pharmaceutical space are moving into cosmetics, the temptation is to think that life will be much easier from a regulatory and compliance perspective. However, while it is true that pharmaceuticals are more heavily regulated, this does not mean that cosmetics developers can rest on their laurels. The subtle lines between making marketing claims about cosmetics that are deemed allowable and those crossing the line into drug products can often be blurred. The wrong claims can cause a cosmetic product to be misbranded attracting unwanted attention from the US Food and Drug Administration. In this podcast with John Bailey and Catherine Bailey from EAS Consulting, we take a look at the various common compliance issues that can arise when jumping the boundary from drugs to cosmetics.
The Cannabinoid Opportunity for Cosmetics & Pharma
23:58Cannabinoids have caught the attention of Pharma and Cosmetic companies alike in recent years, celebrated for their anti-inflammatory, anti-oxidant and anti-bacterial properties in cosmetic products, and neurological and chronic pain benefits on the pharma side. There is also rising consumer demand for cannabinoids, exacerbated by a shift towards ‘natural’ and toxin free products, which present an interesting opportunity for ingredient manufacturers and producers. In this podcast we speak to Dr. Monica Vialpando, founder and CEO of Via Innovations about the promising applications of cannabinoids, the innovative approaches to product development and formulation, and examining the regulatory and legal considerations of bringing these products to market and whether there is an opportunity for pharma companies to diversify into the cosmetics market.
M&A strategies in the CDMO sector
24:32The contract development and manufacturing organisation (CDMO) market is projected to grow to just short of $158 billion by 2025 as a CAGR of 6.9%, amid increasing appetite from biopharma and pharma companies to outsource their manufacturing. In many cases, M&A gives companies the opportunity to expand their reach beyond certain geographies or beef up their service offerings with additional capabilities in the development and manufacturing chain. In this month’s podcast, we speak to Kevin Bottomley, partner at global corporate advisory firm focused on healthcare and life science companies, Results Healthcare, about what is driving M&A strategies in the pharma space and whether investors see high potential for the highly fragmented CDMO sector.
CPhI Discover: Spray Drying
18:29Spray drying is used in various pharmaceutical applications and has become an increasingly popular technique in the production of formulations of poorly soluble APIs and inhalable dry powder formulations. This remarkable technology involves spraying a liquid formulation through a nozzle creating small droplets that dry and produce a powder in one single step. In pharmaceutical manufacturing, spray drying is suited to the production of peptides, proteins, and poorly water-soluble APIs, because it allows them to be co-processed with amorphous form stabilizers or solubility enhancement excipients. Another advantage is that the approach reduces the number of unit operations, potentially lowering manufacturing costs. In this podcast interview with Stefano Console, Senior Advisor and Founder at Oriento, we explore how spray drying can overcome the problem of low bioavailability that all too often stalls clinical testing programmes as well as how it can help in drying and formulating biologics compounds.
CPhI Discover: Cocrystals
12:16Co-crystals are crystalline materials composed of two or more different molecules, typically active pharmaceutical ingredients and co-crystal formers in the same crystal lattice. Tailoring of co-crystals can provide opportunities to not only enhance bioavailability and stability but also the processability of APIs during drug manufacturing. In 2018, the US Food and Drug Administration published guidance clarifying the regulatory classification of pharmaceutical co-crystal solid-state forms for companies planning to submit new drug applications. This move has generated a lot of interest in the co-crystal field. In this podcast, we talk to Andy Singh, Founder and CEO at Asha Pharma about how the use of co-crystals has evolved and what are the best approaches to screening and selecting co-crystals to identify the most viable ones to help find suitable development candidates.
CPhI Discover: Hot Melt Extrusion
10:15While hot melt extrusion was developed in the 1930s and initially used in the plastics and food sector, the pharmaceutical industry has now firmly embraced this technology platform in its manufacturing as a way of solving formulation challenges. Advantages of the approach include the ability to use a wide range of excipients and the ease with which process analytical technology can be incorporated. In this podcast, we speak to Bruce Frank at Lubrizol Life Science Health about how HME has developed as a proven technology for bioavailability enhancement of poorly soluble active pharmaceutical ingredients and drug eluting implants and devices, and how it stacks up against other formulation options in terms of cost and scalability in order to deliver high quality, commercialised pharmaceutical products.
CPhI Discover – A look ahead to three days of insightful content
10:18Our online pharma event CPhI Discover is almost upon us! While we’ll be delving into the typical themes of ingredients, manufacturing, supply chain logistics and technology, we’re also going to be examining some newer trends which are impacting on pharma manufacturing and distribution – such as highly politicized issues such as the change of administration in the US and Brexit and of course, the sector’s drive towards sustainability. In this podcast, Informa Markets’ Head of Content, Tara Dougal and Pharma Editor, Gareth Carpenter run the rule over a packed three-day agenda running from 18-20 May of webinars, podcasts and learning labs.
Pharmaceuticals in the Environment and Antimicrobial Resistance
28:10Pharmaceuticals discarded in the environment pose a risk to fish and other wildlife, for example by affecting their ability to reproduce, by altering their behaviour in ways jeopardising their survival, or through direct toxic effects. Increased awareness has prompted further investigation, as well as calls and proposals for action to reduce emissions to the environment, in particular to water but also to soil. Incorrectly disposed medicines may also contribute to the serious problem of antimicrobial resistance (AMR). In this podcast we talk to Dan Caldwell, PhD, Toxicology Fellow, Johnson & Johnson and Steve Brooks, Advisor to the AMR Industry Alliance about what progress the industry is making in terms of addressing the multifaceted challenges that the release of pharmaceuticals poses to the environment, looking at all key points within the pharmaceutical lifecycle.