Since we last reported on Biovian, the Finnish one-stop-shop Contract Development and Manufacturing Organisation (CDMO) for biopharmaceuticals, the company has undergone in 2024 a transformational development – backed by their common shareholder, Keensight Capital, Biovian has joined forces with another leading CDMO, the Spanish company 3P Biopharmaceuticals, to form 3PBIOVIAN, a major pan-European CDMO delivering end-to-end services to biotech and pharma companies globally.
The combination of the two companies strengthens their value proposition to address complex customer needs across the entire development cycle. The company’s services now cover the full chain from early development to commercial supply for both drug substance and finished vial for biological processes covering microbial and mammalian protein expression platforms, cell and gene therapy and plasmid DNA production. The company is set to serve its global customer base from its two manufacturing sites in Pamplona-Noáin, Spain, and Turku, Finland.
Entering a new era
“With a common shareholder, it made sense to create a stronger CDMO with complementing activities, says 3PBIOVIAN deputy CEO Antti Nieminen. “3PBIOVIAN can offer full end-to-end services in all main modalities and falls into the mid-size CDMO category, with a strong presence in Europe and also increasing business in the US and certain other markets.”
“We can cover the entire value and supply chain, from pre-clinical to commercial and from process development to Drug Substance and Drug Product. This significantly enhances our value proposition. We aim to facilitate swift drug development and delivery, reducing time-to-market for our customers”, adds Dámaso Molero, CEO of 3PBIOVIAN.
“A customer-centric and flexible approach has always been in our focus – not only in marketing messages but also in everyday work within client projects,” he says, adding that customers can join at different stages of their journey within flexible partnerships built around their specific requirements and demands.
The Company has recently invested significantly in both technologies and facilities, but Nieminen affirms that the most important investment is being made in the workforce. “We are in a lucky position here in Turku – a fairly small town in Finland, but one that has the pharma industry, universities, the diagnostic industry. As such, it also has critical professionals available.”
“We employ highly skilled and motivated people in both sites, with experience and expertise secured by a high retention rate of over 90%. We support our people and people stay with us. We also make sure that we offer suitable career development programmes.”
Just recently, 3PBIOVIAN was awarded a prestigious BWB (Biotech Week Boston) Talent Acceleration prize, in recognition of an organization showing an exceptional aptitude for training scientists to develop the skills they need to thrive in the rapidly growing biopharmaceutical industry. To be considered, a company must offer a best-in-class training and development programme with a proven track record of excellence that sets a new standard for the industry at large.
New facilities, more capacity
3PBIOVIAN has made significant investments to meet the evolving client needs and maintain its leadership in innovation and service excellence. The ambitious strategic efforts are focused on upgrading and expanding the operations in both Turku and Pamplona sites. The investments reflect the enhancements in large-scale manufacturing, operational optimization, and biologics development capabilities. With these improvements, 3PBIOVIAN is better positioned to address the growing demands of biologics development and large-scale manufacturing, further strengthening its role as a leading biologics CDMO.
At Turku, the facility investments are centred on strengthening the company’s Advanced Therapies business line. Construction of the purpose-built GeneCity facility is progressing as planned and will house advanced equipment and cutting-edge technologies to support the development and manufacturing of ATMP (Advanced Therapy Medicinal Products), such as adenoviral and AAV (adeno-associated viral) therapies. The facility will also feature dedicated Class A to D cleanroom areas for bulk drug substances as well as final drug product manufacture. The construction is expected to be completed by the end of 2024, with installation of clean rooms and utilities continuing into 2025.
“A few years ago, the Turku site also commissioned one new fill line. This Annex 1-compliant line is currently used for recombinant protein and other BSL1 product fills. Additionally, the Turku site also has a BSL2 fill line and is currently expanding the capacity for BSL2-classified products” reveals Nieminen.
On the other side of Europe, 3PBIOVIAN’s Pamplona site in Spain has been investing heavily in expanding its large-scale manufacturing capabilities, making it a key player in biologics production. These upgrades include increasing bioreactor capacity and optimizing production processes to handle complex biologics, such as monoclonal antibodies and recombinant proteins.
The site has also integrated advanced downstream processing technologies and quality control systems, further solidifying its capabilities in clinical and commercial production. These improvements are aimed at ensuring a streamlined and robust pipeline for biologics products. The Pamplona site is well-equipped to meet the demands of both clinical and commercial-scale production, supporting clients at every stage of their biologics journey.
On the product side, 3PBIOVIAN has developed its own AAV manufacturing platform called AAViator™. The platform includes selected cell line, freedom-to-operate Helper, Rep-Cap and gene-of-interest plasmids, optimised transfection, a USP process as well as a chromatography-based purification process. “We need to be at the forefront of development in these new modalities, as the landscape is continuously changing, and the requirements are also changing. After almost three years of development, the AAViator™ Platform is now ready.”
The company has a full set of In-Process Control and specification analysis available in-house, and to complete viral vector full end-to-end services, the Turku site has also established additional capacity for plasmid DNA (pDNA) manufacturing. “We can offer both HQ (high quality) and GMP pDNA for our clients from 45L in HQ and up to 200L scale in GMP,” says Nieminen, adding that plasmids will be produced with 3PBIOVIAN´s plasmid platform process.
A positive view of the future
Following a series of challenging years, there are signs that financial markets are slowly reviving, affecting early-stage biotech funding, reflects Nieminen, when asked about imminent developments. “We also see that pharma outsourcing requirements are steadily increasing. 3PBIOVIAN is ready to respond to our clients’ increasing development and GMP manufacturing requirements.”
In this process, suppliers play a critical role in any CDMO business’s success, securing material deliveries on-time and cost effectively. 3PBIOVIAN also collaborates with vendors in implementing new technologies in upstream, mid-stream, downstream processes to be able to offer state-of-the-art process and analytical solutions to our clients.
Right now, the focus is on consolidating the two companies. “We have advanced in our integration initiatives and are already utilising the synergy impact enabled by the group. We have a global sales and BD team responsible for different modalities, complementing each other in many respects,” says Nieminen.
“For example, commercial scale recombinant protein manufacturing will be handled in Pamplona, whereas fill and finish will be done at the Turku site. We have also extensive analytical capabilities available on both sites, further enhancing the comprehensive service offering of 3PBIOVIAN.”
In concluding, he affirms that the 3PBIOVIAN will aim to increase its presence in the US market, which offers the biggest opportunities. Continuing to work with key modalities, while investing in capacity, will pave the way for 3PBIOVIAN’s future growth.
