Company profile for Axplora

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Axplora- The partner of choice for complex APIs.

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Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.

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INTERVIEW #SpeakPharma

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"Axplora’s leading position in ADCs and how it is well-placed to serve the burgeoning GLP1 market"
This week, SpeakPharma interviews Martin Meeson, CEO of Axplora, a leading and reliable API manufacturing partner to some of the world’s biggest pharma and biotech companies. Meeson discusses Axplora’s expansion in the antibody-drug-conjugate (ADC) space and how it is well-placed to serve the exciting market for glucagon-like peptide 1 (GLP-1) drugs with its industrial footprint and purification technologies across several sites. 🔑 HIGHLIGHTS// API manufacturing partner to some of the world’s biggest pharma and biotech companies As a leader in the pharmaceutical industry, what inspired you to join Axplora? And, what do you consider the most rewarding aspect of your role as its CEO? When you look at Axplora as the custodian of strong brands like Farmabios, Pharmazell and Novasep you cannot help but be intrigued by what such breadth of offering and depth of technical expertise can achieve. Well, I was certainly intrigued! As a leader in the pharma space, the opportunity to guide an organization with several decades of experience is inspiring for me. For example, our site in Leverkusen was founded over 150 years ago by Alfred Nobel. With every meeting and site visit, I get increasingly impressed by the capabilities of the people that I meet. Now, it is my job to make sure that these capabilities are given the best opportunity to serve. In this sector, we have the privilege of working with our partners to supply and develop medicines that have such a positive impact on people’s lives. This for me is the most rewarding thing that we do. Sometimes the work that we do can seem a little far away from the patient. I always take time to remind myself, my staff, and hopefully also your readers of what we are doing and how our work impacts others. 🔑 HIGHLIGHTS// strong brands like Farmabios, Pharmazell and Novasep / positive impact on people’s lives How have recent industry developments influenced both API manufacturing and CDMO sectors, and what specific strategies has Axplora implemented to adapt to these changing market dynamics while maintaining its commitment to quality and innovation? As a CDMO, when you partner with us, there is always a focus on reliable supply, and we are still haunted by the challenges all of us faced during the pandemic. At Axplora, we have implemented numerous initiatives to increase the robustness of supply, particularly in looking at advances in sourcing and horizontal integration both within and across our network. At the same time, we have a strong focus on the impact that we are having on the planet and Axplora’s work in this area is tremendous — from increasing the amount and efficacy of waste management, notably the current programs around solvent recovery and recycling, to implementing more environment-friendly technologies such as electrochemistry. I am particularly excited by the cutting-edge work on moving to completely new processes that are water-based rather than solvent-based, creating a step change in impact for us and our partners. In addition, as a CDMO you have to constantly look at where your services fit within evolving markets. Axplora’s expansion in the ADC sector is an excellent example of tracking and investing in emerging technologies. Of note also is the current demand for GLP-1 medicines, and Axplora is well-placed to serve this exciting market with our industrial footprint in small molecules and purification technologies across several sites in our network. 🔑 HIGHLIGHTS// increase the robustness of supply / efficient waste management programs and environment-friendly technologies Can you discuss any recent advancement or breakthrough in API manufacturing or CDMO services at Axplora that have contributed to the company’s success? Our investment in ADC expansion is a key strength. Our Novasep business has some of the world’s leading capabilities in API manufacturing and purification. It is known worldwide for these capabilities. With increasing demand for GLP-1 drugs and the amazing impact they are having on patients globally, we are ready to support this growth across our extensive network. The race to oral dose medicines in this space is particularly exciting, and Axplora is looking forward to treating the vast patient population in diabetes and obesity. 🔑 HIGHLIGHTS// expansion in the ADC sector / treat the vast patient population in diabetes and obesity Looking ahead, what are some of the trends or developments you foresee in API manufacturing and CDMO services, and how is Axplora preparing to stay ahead of the curve in this ever-evolving pharmaceutical landscape? Whilst the landscape is evolving rapidly, regulations are not necessarily able to keep pace with the development of new molecules. The pandemic revealed that things can move more quickly. When I look at the challenging new regulation in adjacent spaces like cell therapy, I wonder how that pace can be applied to our sectors. To that end, you have to remain agile and responsive to customer needs. We have to ensure we invest to grow our capacity in the right areas. Our recent investments in Farmabios in Gropello Cairoli (Italy) to support our thriving steroids business and in Pharmazell in Vizag (India) to advance our specialty business are clear indications of how we can do this very successfully. It would be easier if I could point to just one thing that we are doing, but that is not how we win. The only way to stay ahead is by making a myriad of large and small adjustments and evolutions and that is where the Axplora group excels. Finally, one element I should mention is that we are part of a global supply chain. Therefore, our broad network stands ready to supply medicines to multiple geographies. Our investments reflect our worldwide customer base and ambitions. We are here to serve our partners and their patients. 🔑 HIGHLIGHTS// recent investments in Farmabios in Italy and Pharmazell in India / ready to supply medicines to multiple geographies

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https://www.pharmacompass.com/speak-pharma/axplora-s-leading-position-in-adcs-and-how-it-is-well-placed-to-serve-the-burgeoning-glp1-market

#SpeakPharma With Axplora
23 May 2024

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DATA COMPILATION #PharmaFlow

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CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions
The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US