Examining the State of Biopharma Investment

Drug Solutions

Understanding is crucial to ensure the right balance in manufacturing technologies and proccesses is achieved.

Balancing Change and Certainty in Manufacturing

Obstacles remain before broader application of intensified processes can be implemented.

Formulating Drugs for Continuous Processing

Limitations in production platforms have impeded continuous manufacturing for advanced therapies.

Small Footprint Automated Closed Production Platforms

Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.

Considerations for Analytical Testing for E&L

Challenges, Sustainability, and Big Trends in Outsourcing Today

Corning Pharmaceutical Technologies announced its Velocity Vials Technology Platform on June 8, 2023 to increase access to Corning’s Velocity Vial technology. This will allow industry leaders to make and sell the product, in addition to providing more choice to pharma and biotech companies.

According to the company press release, Corning will expand its manufacturing footprint, localize its supply chains, and enable the purchase of Velocity Vials through a network of selling partners. The new partnership with Gerresheimer AG will combine Gerresheimer’s extensive glass converting expertise with Corning’s innovative external vial coating technology, which helps with co-manufacturing and selling Velocity Vials.

Shortly after, SGD Pharma joined and announced a joint venture with Corning that includes the opening of a new glass tubing facility and expanded access to Velocity Vial technology in India. Further, Velocity Vials are important to the global distribution of essential vaccines and medications during the COVID-19 pandemic, according to the company.

“We are starting to see a paradigm shift in the pharmaceutical primary-packing industry, where coated vials are becoming the new industry standard,” said Brendan Mosher, vice president and general manager, Corning Pharmaceutical Technologies, in a press release. “Velocity Vials have demonstrated immediate benefits for our customers. The adoption of the technology by leading pharmaceutical-packaging providers is yet another proof point of this evolution.”

Velocity Vials can improve filling-line efficiency by up to 50%, which lowers costs while also improving the quality. It can also reduce the likelihood of damage that leads to cracks, breaks, and cosmetic defects. The vials are made with Type 1 borosilicate glass and conform to ISO standard dimensions, and they can be dropped-in to existing operations with no significant changes or reporting to regulatory authorities, according to the company press release.

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This will allow industry leaders to make and sell the product, in addition to providing more choice to pharma and biotech companies.

New Velocity Vials Technology Platform to Expand Industry Partnerships

Chris Spivey is the editorial director of 

The BIO International Convention 2023 was held from June 4 to June 8 in Boston, Mass.

Its been a while since I attended the BIO conference, this year held in Boston. I’d forgotten how key a feature the speed dating booths are to the success of many attendees time at the event. Post pandemic these booths were figuratively bursting at the seams with energetic conversation.

To follow-up an alliance dialogue with Scott Ripley, general manager of Nucleic Acids at Cytiva, I stopped by their booth. Having missed Scott, who took a flight home already, I wound up talking with their commercial lead Fiona Fitzgerald. As a consequence Fiona attended the 

 (AMM) soft launch reception, which consisted of very high level industry leaders participating in support of this Alliance, 

Cytiva then expressed interest in not only learning more about AMM, but learning more about the wider therapeutic application mRNA is now being turned toward. In return I wound up learning a good deal more about Cytiva’s nucleic acid group and what their future plans pivot around. The newly formed nucleic acids team at Cytiva supports customers throughout the manufacturing workflow for oligonucleotides and purification of mRNA drug substances. In collaboration with their colleagues at Precision Nanosystems, they help bring mRNA lipid nanoparticle therapeutics to market.

BIO is a powerful business development conference and can help make a lot of deals become reality. It’s power hinges on its ability to draw in the best and the brightest from all of Biotech increasingly extensive web of activities.

BIO is a powerful business development conference that can help make a lot of deals become reality.

Business of Being at BIO

On June 8th, at the Bio conference in Boston, Samsung Biologics announced a long-term agreement with Pfizer that enlarges and extends a March $183M manufacturing deal between the two. This strategic collaboration will focus on long-term biosimilars manufacturing, and more specifically for the Pfizer biosimilars portfolio group; the agreement is estimated at an initial $411 million, according to 

 by the CDMO. To get to this point Samsung appears to have leveraged positive word of mouth from its partnership to produce COVID-19 vaccine material for Moderna.

According to a company press release, Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology. Samsung will use its newest facility, Plant 4, for the manufacturing.

“We are pleased to extend the strategic collaboration with Pfizer as we share and support their strong vision to bring innovative solutions for patients around the globe,” said John Rim, president and CEO, Samsung Biologics, in the release. “This new meaningful partnership comes just as our Plant 4 is fully completed early this month as we had previously committed and are on the move for future expansion into our second campus in order to provide our clients with even more flexible and advanced manufacturing technology.”

“Our collaboration with Samsung Biologics will have the potential to significantly improve the lives of patients globally,” added Dong-Wook Oh, country manager, Pfizer Korea.

With the blockbuster Humira now open to biosimilar competition, that production application seems likely to be an early target. However, while biosimilar introductions have not drastically reduced prices as originally hoped, at least 

 Humira biosimilars are expected over the next few months and some could debut with heavily discounted prices. This includes Amgen’s Amjevita, Samsung’s [partnering with Bioepis/organon] Hadima, and Pfizer’s Abrilada. AbbVie has made 

Samsung biologics also announced that the company will start operating its fifth plant in April 2025, five months earlier than its original schedule, in order to meet a rush of orders from global big pharma companies. Upon the plant's full completion, the company will have a biomanufacturing capacity totaling 

The collaboration between Samsung Biologics and Pfizer will focus on long-term biosimilars manufacturing.

Biosimilar CDMO Capacity Increased in Samsung Biologics – Pfizer’s New Arrangement

Merck, known as MSD outside of the United States and Canada, announced that it had officially filed a complaint against the US government on June 6, 2023. According to a company statement, the complaint alleges that the price controls introduced by the Inflation Reduction Act (IRA), which require the Centers for Medicare and Medicaid Services to begin setting prices on small molecule medicines at nine years and large molecule medicines at 13 years, are unconstitutional and will stifle biopharmaceutical innovation.

The complaint cites the Fifth Amendment, which states that the US government must pay “just compensation” if it takes property for public use. In the statement, Merck argues that the IRA allows the government to coerce Merck to provide biopharmaceutical innovations without providing equitable value for them.

“Patients and the public need biopharmaceutical innovation to address global health challenges like cancer and Alzheimer’s disease, and the IRA is negatively affecting critical research and development,” reads the statement. “By changing the incentives and returns for some therapies and technologies over others, the IRA is changing the course of R&D, which in time will leave many patients without treatment options.”

“The Biden-Harris administration is going to fight attempts to go back to the way things were before,” said Karine Jean-Pierre, White House press secretary, in a statement to the press regarding the suit. “And so, we are confident we will succeed. There is nothing in the Constitution that prevents Medicare from negotiating lower drug prices. Anytime profits of the pharmaceutical industry are challenged, they make claims about it hindering their ability to innovate.Not only are these arguments untrue, but the American people do not buy them.”

The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.

Merck Files Lawsuit Against US Government

Waters Corporation and Sartorius announced a new analytics collaboration on June 5, 2023. This agreement, which expands on their existing agreement that focused on upstream bioprocessing analytics, aims to develop integrated analytical solutions for downstream biomanufacturing.

According to a company press release, the collaboration will use Waters’ liquid chromatography and Sartorius’ multi-column chromatography platforms to develop a more comprehensive analytical data solution. This system will be used for downstream batch and continuous manufacturing with the goal of improving yields, reducing waste, and cutting costs.

“From the beginning of our collaboration with Sartorius, we’ve strived to give bioprocess engineers faster and more direct access to critical quality attribute information about their drug products in the name of improving production yields and getting drugs to patients faster,” said Jon Pratt, senior vice-president, Waters Division, in the release. “Based on the positive response of customers to our collaborative efforts with upstream bioprocessing analytics, we see tremendous benefit to combining [our platforms] to bring timely point-of-decision analytics to downstream biomanufacturing for monoclonal antibodies, recombinant proteins, vaccines and AAV gene therapies.”

“Now that intensified, continuous manufacturing of biologics is becoming a reality, there is a greater need for real-time analytical measurement,” said René Fáber, head of Bioprocess Solutions Division, Sartorius, in the release. “The value of combining technologies from Sartorius and Waters lies in bringing fundamentally important analytics to the point where it is needed and giving bioprocess engineers a more complete understanding of their downstream manufacturing processing and its effects on drug product quality. We believe this can have significant impacts on drug production costs by helping to increase yields and reduce waste.”

Sartorius and Waters will collaborate to develop integrated analytical solutions for downstream biomanufacturing.

Sartorius and Waters Expand Analytics Collaboration

FDA announced the availability of the draft guidance, E6(R3) 

on June 5, 2023. Prepared by the International Council for Harmonisation (ICH), the GCP guideline provides a standard for facilitating a mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. According to the guidance, the document builds on key concepts outlined in ICH E8(R1) 

General Considerations for Clinical Studies

This includes, but is not limited to, fostering a quality culture and designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, and engaging stakeholders. Further, this guideline is applicable to other interventional clinical trials of investigational products that are not intended to support marketing authorization applications in accordance with local requirements.

The principles outlined in the guidance are intended to apply across clinical trial types and settings and to remain relevant as technological and methodological advances happen, according to the guidance. It should also be read in conjunction with other ICH guidelines relevant to the design and conduct of clinical trials.

The document builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.

Good Clinical Practice Draft Guidance Revealed for Clinical Studies

Domino Data Lab, a data science and artificial intelligence (AI) platform company, announced various new capabilities at the Rev 4 conference on June 1, 2023. The expansions to MLOps, the company’s platform that uses custom large-language models and generative AI applications to develop and deploy data science solutions, are designed to enable democratized access to various AI ecosystem changes. Expansions include a new AI project hub, additional cloud-based offerings, and the Model Sentry capability suite.

The new AI project hub uses pre-trained foundation models and project templates to connect users and enable them to select an optimal foundation model as well as to connect users to their data and generate code to fine-tune that data. The hub also has various auto-scaling compute clusters for large-scale distributed data preparation and model training.

The company’s new cloud offerings include Domino Cloud for life sciences (DLCS), an audit-ready specialized AI cloud platform intended for use in the pharmaceutical industry. DLCS is designed to accelerate drug discovery, optimize research workflows, and maintain strict regulatory compliance within a secure, collaborative, and fully managed platform.

The Model Sentry is a suite designed to mitigate model risks, implement responsible AI practice, and eliminate AI development overspend. The solution uses a unified model registry for complete lineage tracking, as well as automated model cards for auditing purposes.

"AI is an existential business imperative. The winners will be those who wield it with speed, responsibility, and fiscal savvy," said Nick Elprin, CEO and co-founder of Domino Data Lab, in a company press release. "We're backing our customers with the resources to outshine in these key areas and unleash AI to change the trajectory of civilization."

Domino Data Labs’ expanded platform includes a new project hub, additional cloud offerings, and the Model Sentry solution suite.

Domino Data Labs Expands AI Platform

Feliza Mirasol is the science editor for 

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, announced a €35 million (US$37 million) investment on May 31, 2023 made by its life science business sector into the company’s Glasgow and Stirling sites in Scotland. The investment is intended to increase biosafety testing for drug development and commercialization at those sites.

The investment includes a new 1200-m2 facility in Glasgow that will house molecular biology and sequencing services, and the company will add biosafety testing, analytical development, and viral clearance suites in its current buildings to expand testing capacity. In addition, the expansion will create nearly 500 new jobs, raising the company’s workforce to more than 1200 employees across the two sites.

“We remain committed to ensuring the safety of the world's medicines through our state-of-the-art testing solutions for our customers around the world that drive new treatments,” said Dirk Lange, head of Life Science Services, MilliporeSigma, in a company press release. “Since mid-2022, we have announced investments of more than €350 million [US$374 million] in our global testing network to meet the growing demand for these services.”

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.

MilliporeSigma Invests €35 Million to Strengthen Biosafety Testing in Scotland

invoX Pharma, a UK-based wholly owned subsidiary of China-based Sino Biopharmaceutical, announced on June 1, 2023 the completion of a second tranche of investment in pHion Therapeutics, a UK-based vaccine development company. The investment is meant to further develop next-generation messenger RNA (mRNA) vaccines.

The investment will support growth of pHion’s proprietary RALA platform. One of the first priorities will be the advancement of PTX_V1, pHion’s lead project, into clinical trials in the first half of 2024. PTX_V1 is a first-in-class therapeutic vaccine in development for treating human papilloma virus-related cancers. pHion’s pipeline also includes differentiated therapeutic vaccines for the treatment of ovarian (PTX_V5) and prostate (PTX_V3) cancers.

Operating with its RALA platform, pHion can deliver anionic molecules such as mRNA and self-amplifying RNA in a stealth-like way. This behavior evades detection and allows for the generation of a potent antigen-specific CD8+ T-cell response. The benefit of the RALA peptide-based drug delivery system lays in its 30-amino-acid sequence, which condenses anionic cargo—irrespective of size—into nanoparticles that are highly efficient at cellular entry and are able to outperform currently available technologies, according to a company press release. Compared with traditional mRNA vaccine delivery platforms, the RALA platform’s advantage includes ease of scalability and logistics, including stability at room temperature.

“At pHion Therapeutics, it is our mission to pioneer next-generation, first-in-class vaccines for infectious disease and oncology through stealth-like delivery of mRNA. With the additional support from invoX, we are set to accelerate our lead candidate, PTX_V1, to be ready for the clinic in 2024 and further develop our exciting preclinical pipeline of therapeutic and prophylactic mRNA vaccines. mRNA vaccines have the potential to truly transform healthcare interventions globally, and pHion will be at the forefront of this transformation, enabled by the RALA platform delivery technology,” said Helen McCarthy, CEO and founder of pHion, in the press release.

“We are delighted to have completed this additional investment in pHion,” said Ben Toogood, CEO of invoX, in the release. “invoX’s resources, global reach, and innovative R&D platform can help the company reach its potential and deliver treatments for patients around the world suffering from cancer and infectious diseases. We look forward to seeing PTX_V1 reach the clinic and supporting this program into the next stages of its development.”

invoX Pharma has made a second tranche of investment in pHion Therapeutics to support further development of next-generation mRNA vaccines.

invoX Pharma Invests in pHion Therapeutics to Develop Next-Generation mRNA Vaccines

On June 1, 2023, Lonza announced that it acquired Synaffix, a Netherlands-based biotechnology company with an antibody drug conjugate (ADC) technology platform. Under the deal, Lonza will initially pay €100 million (US$107 million) in cash and up to €60 million (US$64 million) in additional performance-based consideration. While it is now a Lonza company, Synaffix will continue to operate under the Synaffix name and will further expand its operations in Oss, The Netherlands, to prepare for further innovation and growth.

Synaffix’s ADC technology platform includes payload and site-specific linker technologies that will enhance and extend Lonza’s integrated ADC services, including Lonza’s early-phase offering. The ADC technology platform comprises proprietary GlycoConnect, HydraSpace, and toxSYN technologies, which can significantly enhance the efficacy and tolerability of ADCs, according to a company press release.

Through the acquisition, Lonza will combine its development and manufacturing capabilities with Synaffix’s ADC technology platform, which the companies expect will provide a comprehensive service to rapidly discover, develop, scale up, and commercialize novel and differentiated ADCs. The combination is also expected to streamline the path from discovery to clinic and commercialization.

“The acquisition of Synaffix underlines the strategic position of bioconjugates within Lonza’s portfolio, expands our offering in this fast-growing market and enhances our value proposition for clinical customers. With Synaffix, our combined … knowledge and capabilities have the capacity to support both clinical and commercial needs,” said Ulrich Osswald, vice-president, Licensing, Lonza, in the press release.

“On our mission to bring Synaffix’s ADC technologies to patients, we are excited to become part of Lonza, and, thus, through strong and immediate synergies, ensure a robust technology and manufacturing platform for our licensees as they progress into the late-stage clinical and commercial development phase. We can now also leverage the potential offered by Lonza to fast-track technology innovations in bioconjugates beyond cytotoxic ADCs,” said Peter van de Sande, CEO, Synaffix, in the release.

Lonza will gain access to R&D capabilities, including payload and site-specific linker technology, through its acquisition of ADC company, Synaffix.

Featured Content

Drug Solutions

Balancing Change and Certainty in Manufacturing

Formulating Drugs for Continuous Processing

Small Footprint Automated Closed Production Platforms

Considerations for Analytical Testing for E&L

Drug Solutions