PharmaSource Podcast

West Pharmaceutical Services is a leading provider of innovative, high-quality injectable solutions and services and a trusted partner to established and emerging drug developers.

West has more than 10,000 team members across 50 sites worldwide, and supports customers by delivering approximately 47 billion components and devices each year.

“This year is our 100 year anniversary, a milestone we are very proud of.” says David Maier, Vice President & General Manager, Global Generics Market Unit at West. “Every product has a patient’s name on it.”

West’s products range from stoppers and seals for injectable packaging systems, to self-injection and reconstitution systems. The company plays a key role in supporting vaccine manufactures through supplying high performing containment systems, scalable packaging, and regulatory support.

Speaking to the PharmaSource podcast David explains that during the COVID-19 pandemic, West components were used in the majority of vaccines on the market.

“We supported the delivery of over 8 billion doses of vaccine. This required significant efforts to ramp up production and to shift priorities in order to put enough capacity online.”

Sustainability through partnerships

“Collaboration between vendors and customers is critical if the pharma industry is to address emissions, energy usage, water usage and waste reduction.” says David.

“West takes a concerted, cooperative approach with our customers and other stakeholders to work together to achieve ESG targets. This includes investigating shared power purchase agreements, researching more sustainable materials, exploring more efficient shipping methods, and studying beneficial reuses of our products.”

West have announced a new sustainable technology as part of their long-term collaboration with Corning.

West is the exclusive distributor of Corning Viridian™ Vial Technology, a drop-in solution that can reduce vial manufacturing CO2e emissions and material waste while enabling faster and safer fill-finish operations.

In addition, West are finalists for their FluroTec® 5-10mL Cartridge Plunger, NovaPure® Stoppers & Flip-Off® CCS Seal technology for large volume injections.

Key trend for 2024: GMP Annex 1 in Europe

“The European Union is not the only territory where the bar of expectation is being raised when it comes to regulatory standards for particulates. "

A deliberate and well-documented contamination control strategy is one of the new focuses in the EU GMP Annex 1 revision. West is well-positioned to help partners prepare for these regulatory changes, says David.

Key trend for 2024: Home-Based Healthcare Market Expansion

Another major trend is the way the home-based healthcare market is expanding, driven by patient demand for more convenient treatment options.

David explains that West’s on-body platform SmartDose® was the first large-volume wearable to be approved as a combination product by the FDA and has since evolved with multiple generations and different sizes.

“SmartDose® helps to provide patients with confidence in their therapy as it is designed to reduce the need for frequent visits to infusion centres. The technology has been approved for use in four different therapies in the market.”

Read the full articles here

Clariant, the 5 billion multinational company specialising in chemicals, is releasing a range of new functional excipients

The company is a global leader in specialty chemicals and manufactures a wide range of APIs and Excipients in Germany, Spain and China.

While in the past their reputation in pharma was for manufacturing mainly Polyglycols, Vaios Barlas, Global Director Health Care at Clariant explains that they have been focused on expanding their Excipient offering.

“Excipients are ‘the vehicles of drug delivery systems’ and are growing very fast for us. Four out of ten API’s are not soluble, our body is practically all water, so you need functional excipients to be able to make them bioavailable – soluble and permeable in our organs.”

Clariant have a comprehensive portfolio of excipients including solubilizers, emulsifiers, solvents rheology modifiers, binders, humectants plasticizers and many different kinds of agents. 

Among Clariant’s standout offerings are its high-purity VitiPure® O 80 Superior, a purified Polysorbate 80 as well as the new VitiPure® CO 35 Superior, a Polyoxyl 35 Castor Oil and its low endotoxin and microbial load VitiPure® Meglumine LEX.

Clariant also offers a comprehensive selection of Polyglykols (Macrogols), which serve as universally applicable pharmaceutical polymers. Notably, these polymers boast a spectrum of molecular weights and are fortified with CEP certification and DMF documentation, underlining their quality and regulatory compliance.

Clariant are a “top-ranked” supplier for both generics and originator pharma companies, says Vaios. He highlights a recent independent survey that placed Clariant in the top five suppliers for customer loyalty, as ranked by the global pharma industry.

“At Clariant our motto ‘greater chemistry between people and planet’ is our raison d’etre. It’s why we exist” says Vaios.

“In the face of the global challenges of climate change and global health and nutrition issues, we feel we bear a responsibility and have to ask ourselves, what contribution we can make.”

“It’s both a company and a personal commitment to society and to the planet to innovate, find solutions to the challenges and bring technological solutions that are friendly for the people and the environment. That’s the big challenge we’re trying to live up to in Clariant”

As an example, Clariant produce bio-ethanol based ethylene oxide, which will allow them to produce Excipients and APIs with low carbon footprint in future.

“Over time this has to become an industry standard.” says Vaios.

Reflecting on key trends shaping the industry, Vaios highlights the importance of personalised medicine.

“Pharma companies are using artificial intelligence and big data to develop targeted therapies that are customised to the patient’s genome and the medical history. This is happening at rates faster than ever before.”

The delivery of complex injectables in the form of liposomes is moving the pharmaceutical industry rapidly forward, says Vaios.

“At Clariant we are participating in this, as we did with our methoxy-PEGs and the mRNA vaccines for COVID-19. I believe this has potential to address critical diseases such as cancer, HIV and infectious viruses in a way that was impossible to imagine a few years back.”

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Alcami is a contract development and manufacturing organization (CDMO) headquartered in North Carolina with four-decades experience advancing products through every development lifecycle stage.

Operating across five campuses across the United States that cover 738,000 square feet, Alcami caters to pharmaceutical and biotech enterprises of all scales. The CDMO offers bespoke and inventive solutions for analytical development, clinical to commercial sterile and oral solid drug product manufacturing, packaging, microbiology, cGMP biostorage, environmental monitoring, and pharmaceutical support services.

We spoke to Timothy Compton, Chief Business Officer Alcami to explain more.

“Biologics is a growing area for us.” says Tim. “We’ve been supporting biologic products for about 20 years. We have growing capabilities within sterile fill-finish, and a 50/50 split between a traditional small molecule and biologics products.”

“We are opening a new 65,000 square foot cGMP biostorage facility in North Carolina this year. For us, it’s about maintaining scalability for our customers, we certainly don’t want to run out of run of capacity in support of the growth of our our customers programmes.”

Unmet need for downstream capacity

“Analytical support for the characterization or release of those bulk drug substances; sterile fill finish, drug product manufacturing of those products; the storage of materials to support the manufacturing and the BDS itself. We feel there’s a tremendous unmet need there in the industry, and one that we feel that Alcami can help fill.”

“It’s not just by adding capacity and capabilities.” says Tim. “It’s about providing a personalised  approach to customers. Everything we do is a customised approach to their needs.  We’re always pivoting to support what’s required for their programmes to be successful.”

Read the full article

"We are the bridge between the manufacturers of raw materials and ingredients to those that produce medicines. We develop partnerships with all types of companies from big pharma to startups" says Catarina Gil Forte, Head of Industry for Synthesis & Biopharma at Brenntag Pharma.

More than just manage the logistics and warehousing, Catarina explains that Brenntag aims to simplify the complexities of pharma and biopharma supply chain operations with a range of value-added services.

These services include:

Reflecting on the current economic environment, Catarina notes that due to inflation some customers are struggling with getting the right balance of stock-levels.

"Working capital is an important topic at the moment and distribution can play an important role here. We can support our customers on defining their forecasts and ensuring that they receive the product on time, and do not overstock their warehouse."

"There is a big responsibility with our product managers to get the right balance between the products that we have in stock, and those that need to be supplied on time. We also support customers in managing costs by working with the best partners from supplier-side."

Read the full article on PharmaSource

Novartis has been active in the contract manufacturing space for twenty years, now under the brand name Global Biotech Cooperations.

Novartis Global Biotech Cooperations provides contract manufacturing services across various domains, including Cell & Gene Therapy, Plasmid DNA, RNA, mRNA, SiRNA, Microbial manufacturing, Mammalian cell cultures, Viral vector, and Fill & Finish.

In this episode Rathish Ravindrakumar, Business Development Director, Novartis Global Biotech Cooperations, explains how in the last 2-3 years they have been receiving more requests for newer technologies like Cell and Gene Therapy.

“These technologies represent both an opportunity and a challenge for some companies to get the required capacity. We can help these companies to manufacture their medicines as we have built our capabilities in these technologies.”

Sustainability is high on the Novartis agenda. Rathish highlights how the harmful effects of climate change are now clear to see, and will requires immediate and sustained action by all stakeholders.

“Sustainability has become the key issue for all contract manufacturers as pharma companies take proactive steps to deliver value chain emission reductions.”

“One of Novartis’ business objectives is building the green operations of the future” says Rathish “If you look at recently published analysis, Novartis is already ranked highly for its efforts to reduce greenhouse gas emissions.”

As an example of the work Novartis is undertaking, the company recent transitioned to 100% renewable energy in one of its large-scale sites. This is part of a group-wide sustainability journey to be carbon neutral across its own operations by 2025 and across its supply chain by 2030.

Full article here

The company was founded in 2014 after the acquisition of Boehringer Ingelheim's phytochemical API product portfolio.

"In 2023 after 9 years hard work we finally reached goal of becoming the global leader in Ophthalmic APIs” says Serge Tarabay, Senior Business Development Manager at C2 Pharma.

He describes the company's ambitious plans to release two to three Ophthalmic APIs every year to expand further into the market.

C2 Pharma's extensive API product catalogue now encompasses a diverse range of compounds, such as atropine, bimatoprost, brimonidine, cyclopentolate, homatropine, latanoprost, pilocarpine, and tropicamide - and have recently received approval for Digoxin China DMF. The company serves the needs of over 200 pharmaceutical enterprises spanning across the United States, Western and Eastern Europe, South America, Asia, the Middle East, and Africa.

"C2 is working closely with external operational teams to identify market needs and make sure we have sufficient stock in our warehouses in Europe to ensure continuity of supply. Customers are looking for redundancy in the supply chain to avoid any disruption in production."

Another key issue is how the industry can maintain product quality at a time when cost-pressure is on. This question has now become critical, says Serge.

"When it comes to APIs, where lives are at stake, price should not come at expense of quality. It is important to find reliable partners rather than the cheapest available in the market."

"We are seeing a lot of pressure on costs and are trying to absorb it as much as possible. We have to support customers and always be fair, but we see that quality is costing more and more these days."

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Thermo Fisher Scientific is at the forefront of providing comprehensive pharmaceutical services from drug development, clinical trial logistics to commercial manufacturing.

With a global presence spanning over 60 locations, the company offers a seamless, 'end-to-end' solution across all developmental phases, including API production, biologics, viral vectors, cGMP plasmids, formulation, clinical trial support, logistics, manufacturing and packaging.

Christy Eatmon, Global SME, Sterile Drug Products at Thermo Fisher Scientific, explains how they support pharma and biotech customers of all sizes.

“Being part of such a big company allows us to rely on a global network of people that have breadth and depth of experience. Customers benefit from reducing risk, improving timelines are often able to leverage our buying power."

“We work with all the big pharma companies, as you would expect, but the majority of our customers are actually small and emerging. " says Christy.

"I know a lot of people feel like they might get lost in such a big organisation, but our services are personalised to the needs of a specific client or programme. Supporting small biotechs has always been the heart of our business. Our goal is to enable our customers to make the world healthier, cleaner and safer."

Key trend: Home delivery of pre-filled syringes

“Pre-filled syringes, filled with whatever drug or medicines a person might need, have the potential to be ground-breaking." says Christy. "Rather than patients having to go into clinics for intravenous infusion, they will now be able to inject themselves at home. "

“I don't see that as much different from what diabetics have been doing for years, having a vial of insulin in their fridge and then dosing themselves.  With prefilled syringes and auto injectors patients don't even have to measure how much to give themselves."

Read the full article

Established in 1942 , Lannett is a US-based pharmaceutical contract manufacturer boasting an extensive portfolio of over 100 product families currently in distribution.

“The world is always changing, and so are we. We’re always looking for new opportunities.” says Grant.

“Our team has decades of experience, but that doesn’t mean we’re stuck in the past. We make sure we leverage that experience and knowledge, by being forward-thinking and coming up with creative solutions that apply today.”

Reflecting on the industry trends for the year ahead, Grant is expecting there to be continued consolidation both in the generic and contract manufacturing space.

That’s being driven by companies looking for opportunities to drive their plant utilisation effectively.

“When you’re operating a pharmaceutical plant, you have overhead and infrastructure costs, that that don’t go down. To combat the ever-increasing year over year costs, one way to stay competitive is to utilise the plant effectively and control your costs.”

Read the full article here

Polpharma Group is a CEE-based pharmaceutical manufacturer with 70 years of experience offering various products, including prescription drugs, consumer health care products, and generic active pharmaceutical ingredients (APIs).

David Gonzalez, Head of API Commercial, spoke to the PharmaSource podcast about their new ‘hybrid’ business model, which means they can now offer Contract Development and Manufacturing Organisation (CDMO) alongside their existing Generic API services.

“We are targeting companies with no API experience, for whom we can develop everything from pre-clinical to phase 1 and phase 2 products.”

Polpharma is one of the few companies in Central Eastern Europe that can provide these services, says David.

“Our quality and standards are all European, but (due to our location) we can offer services on a lower cost-base. It is promising and has been well-received by the customers from various markets.”

They are currently expanding their manufacturing capabilities with a $45-million investment to include High Potency Active Pharmaceutical Ingredients (HPAPI) and cryogenic technologies.

The expansion is set to begin operations from mid-2023, with full completion expected by 2026.

“Over the last few months, we have seen many big previously back-integrated companies now selling their generic API units to private equity or independent companies,” says David. Recent announcements have included the divestment of Glenmark Life Sciences as Glenmark Pharma ‘moves up the value chain,’ Teva selling its API division as it ‘pivots to growth,’ and Lupin considering the demerger of its API business.

“Back-integration used to give big companies like this a competitive advantage. This new paradigm means that companies must be focused on fewer products but with full control of the supply chain to remain competitive.”

Read the full article

Dr. Reddy’s Laboratories, the global pharmaceutical company headquartered in Hyderabad, India, has been a key player in the industry since its establishment in 1984.

Committed to ensuring access to affordable and innovative medicines, the company operates under the mantra, ‘Good Health Can’t Wait’. Dr. Reddy’s offers a comprehensive range of products and services, encompassing APIs, generics, branded generics, biosimilars, and OTC medications.

Ahead of CPHI 2023 we interviewed Kalpesh Kumar Modi, VP and Head of Europe API Sales, Dr. Reddy’s to explain their priorities.

“We manufacture more than 200 APIs and specialise in complex APIs, including peptides, oncology, cardiovascular, and all other therapeutic categories.” says Kalpesh.

“Dr. Reddy’s is a vertically integrated pharma companies that can support customers with formulation expertise, improving development processes and timelines, and have global regulatory teams facilitating filings and early market launches..” 

In 2023, the company recently became a ‘Water Positive‘ company, beating their 2025 target by two years.

“We were among the first Indian companies to build a zero liquid discharge infrastructure into all our facilities. We are delighted to say that we are not sending a single kilogramme of waste to any landfill.”

Dr Reddy’s is committed to ESG principles, employing ‘green chemistry’ to make API processes sustainable and work with suppliers who contribute to sustainable supply chain performance.

Kalpesh explains API Plus, an initiative for emerging markets where customers don’t have their own formulation facilities.

“The core objective of API Plus is to ensure that patients of those countries can access high-quality, affordable medicines. We cooperate with local partners and support them with expertise, formulation, and technology.”

Digitalisation is another major focus for Dr. Reddy’s, says Kalpesh. “We are leveraging Industry 4.0 technologies to streamline operations and enhance data accuracy.”

As an example of this, the company has created a platform called XCEED that enables customers to manage the complete inquiry and procurement process of Dr. Reddy’s APIs in real-time.