Your guide to the pharmaceutical world Volume 11 Issue 3 Flow measurement and control Optimising operations Cleaning and maintenance On the spot inspection Warehousing and distribution Adapting to change Flow measurement and control Optimising operations Cleaning and maintenance On the spot inspection Warehousing and distribution Adapting to change www.pbiforum.net NE 28–62 NIMRIEC, B 8 SEPTEM M GHAN MBER 202 32 S VVSA EV D T TETD ETH A !E E ! ON ND NG OR D TETDA !E VISIO TS A AGI NT F PRO T IND RMACHINE OCESSING A ’S NKTHE U DUSTRIAL VISION TS AND O, ROB,R ACKAGING PAND NO.1 EVENT FOR Y KO.U PPMA .CO.ASHOW 10 14 18 26 Steve Fisher (s.fisher@blmgroup.co.uk) Michael Fisher (m.fisher@blmgroup.co.uk) Tess Egginton (t.egginton@blmgroup.co.uk) Angie Cooper (a.cooper@blmgroup.co.uk) Vicky Hunt (v.hunt@blmgroup.co.uk) Tel: +44 (0) 1472 310302 Angela Sharman (a.sharman@blmgroup.co.uk) Gary Jorgensen, Mark Casson, (studio@blmgroup.co.uk) Tel: +44 (0) 1472 310305, Fax: +44 (0) 1472 310317 Armstrong House, Armstrong Street, Grimsby, North East Lincolnshire DN31 2QE England All rights reserved. No part of this publication may be reproduced, transmitted, photocopied, recorded or otherwise without express permission of the copyright holder, for which application should be addressed first to the publisher. While every reasonable care is taken, neither the publisher nor its participating agents accept liability for loss or damage to prints, colour transparencies, negatives or other material of whatever nature submitted to this publication. The views expressed in this publication are not necessarily the views of those held by the publisher. News4 Stay up to date with the latest industry updates from the global pharmaceutical technology industry. M&A round-up10 Since Pharma Business International’s last issue, a flurry of fresh deals has been announced in the pharmaceutical industry. Process, control and automation14 Embracing automation in the pharmaceutical industry is not just a trend, but a necessity for ensuring the safety, reliability, and effectiveness of medications. Training and skills development18 Skills shortages across the pharmaceuticals sector threaten to leave many companies struggling in coming years if they are not already. Flow measurement and control22 Ensuring product integrity, quality, and efficiency in the pharmaceutical industry relies on accurate flow measurement and control. We explore how precise monitoring and regulation help to enhance safety, compliance, and long-term business success. Warehousing and distribution26 The supply chain is being stretched, which means it’s up to warehousing and distribution centres to adapt to the demands and find a solution. Tower Cold Chain Q&A30 This month we meet with Tower Cold Chain, specialists in temperature controlled containers and storage, to see how they’re dealing with the myriad challenges of working in the pharmaceuticals industry. Cleaning and maintenance 32 Hygiene is paramount in pharmaceutical manufacturing, but clean machines also work more efficiently. Events 36 We give a rundown of pharma events happening around the world. @pbiforum www.pbiforum.net company/pbiforum Cover photo courtesy:stock.adobe.com/ wacomka4 Pharma Business International www.pbiforum.net Latest news Fosun Pharma to build manufacturing site in Côte d’Ivoire with IFC partnership To support stronger healthcare delivery and outcomes in West Africa, Shanghai Fosun Pharmaceutical (Group) has strengthened its partnership with IFC to help the company build a pharmaceutical production facility and distribution hub in Côte d’Ivoire. Under the partnership, IFC will provide subsidiaries of Fosun Pharma with two loans totalling 50 million euros to support the construction of a manufacturing site near Abidjan to produce anti-malaria drugs and anti-bacterial medicines. The facility, which will take place in three phases, is expected to have a capacity of 5 billion tablets annually after phase 3 completion. The project will improve access to quality, affordable life-saving medicines across West Africa, contributing to better health outcomes in a region that contends with heavy loads of infectious and other diseases. The project will also facilitate medical and manufacturing knowledge transfer to Africa, supporting the long-term growth and strength of the wider region’s health sector. AVROBIO agrees to sell cystinosis gene therapy program to Novartis for $87.5m AVROBIO, a clinical-stage gene therapy company, has agreed to sell its investigational hematopoietic stem cell (HSC) gene therapy program for the treatment of cystinosis to Novartis for $87.5 million in cash. AVROBIO retains full rights to its portfolio of first-in-class HSC gene therapies for Gaucher disease type 1 and type 3, Hunter syndrome and Pompe disease. Proceeds from this transaction are expected to extend the company’s cash runway into the fourth quarter of 2024. “This transaction strengthens AVROBIO’s balance sheet, focuses our pipeline strategy and is a strong endorsement of our HSC gene therapy approach and plato gene therapy platform,” said Erik Ostrowski, AVROBIO’s interim CEO and current CFO. © stock.adobe.com/ JHVEPhoto VaxEquity and CPI receive Innovate UK grant to accelerate next generation RNA vaccines and therapeutics VaxEquity, developing transformative RNA vaccines and therapeutics based on its next generation self-amplifying RNA (saRNA) platform, and CPI, the UK’s leading independent technology innovation centre, have received a grant of approximately £700k from Innovate UK. The grant will fund a collaborative project to advance the manufacturing process for RNA vaccines and therapeutics. The project will test optimised conditions for scalability in the manufacturing of saRNA with plans to progress a candidate influenza vaccine rapidly into clinical trials. Dr Tim Sparey, Managing Director at VaxEquity, said: “The potential of nucleic acids as vaccines and therapeutics is only just being realised. This powerful collaboration with CPI, fuelled by Innovate UK, starts with a giant step forward in scaling the manufacturing of a novel saRNA influenza vaccine. “With our combined skill and capabilities, we plan to proceed into preclinical and clinical development to bring the world real benefit in the fight against flu. This collaboration will identify, establish, and protect an optimised process for saRNA manufacture which should open up the global horizon to many future vaccine and therapeutics.” © stock.adobe.com/ Aleksej6 Pharma Business International www.pbiforum.net Latest news Zendal and IAVI partner on development of TB vaccine candidate Spanish biopharmaceutical company Biofabri, a subsidiary of Zendal, and IAVI, an international nonprofit research organization focused on developing vaccines and antibodies against infectious and neglected diseases, have signed an agreement for end-to-end development of the tuberculosis (TB) vaccine candidate MTBVAC. This agreement provides a framework for the future of the collaboration that the partners first announced in 2021. Under the agreement, IAVI is supporting development, global regulatory strategy, resource mobilization, and access planning for the adolescent/adult MTBVAC program. This includes an efficacy trial, which IAVI plans to begin in 2024 after securing sufficient funding. With support from the European & Developing Countries Clinical Trials Partnership (EDCTP), Biofabri launched a Phase III trial of MTBVAC (NCT04975178) in neonates in South Africa, Madagascar, and Senegal in late 2022. IAVI will support the MTBVAC infant program, including bringing in additional resources to enable late-stage development, with other expanded roles in the program being planned. Centessa Pharmaceuticals receives Fast Track designation from the U.S. FDA for SerpinPC for hemophilia B The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Centessa Pharmaceuticals’ SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or without inhibitors. “We are pleased with the FDA’s decision to grant Fast Track designation for SerpinPC as we continue to advance the PRESent registrational studies for SerpinPC in hemophilia B,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “This designation is important recognition of SerpinPC’s novel mechanism of action and underscores the critical need for new treatment options for persons with hemophilia B. We believe SerpinPC has the potential to be a first-in-class subcutaneously administered therapy with a differentiated safety profile for persons with hemophilia B, subject to review and approval.” © stock.adobe.com/Kiattisak © stock.adobe.com/ Tatiana Shepeleva Chinook Therapeutics partners with Ionis to develop antisense therapy for rare, severe chronic kidney disease Chinook Therapeutics has entered a collaboration agreement with Ionis Pharmaceuticals, for the discovery, development and commercialization of an antisense oligonucleotide (ASO) therapy for a rare, severe chronic kidney disease with significant unmet medical need. The companies will leverage Chinook’s precision medicine approach and deep expertise in nephrology and Ionis’ extensive expertise in RNA-targeted therapeutics. “We are pleased to collaborate with Ionis on this preclinical discovery program as we continue to strengthen Chinook’s position as the leading kidney disease company,” said Andrew King, D.V.M, Ph.D., chief scientific officer of Chinook. “Developing an ASO therapy enhances our ability to target key genetic and molecular drivers and expands our precision medicine pipeline for rare severe chronic kidney diseases while continuing to pursue our goal of making dialysis and transplant unnecessary for people living with kidney disease.” Under the terms of the agreement, Chinook will pay Ionis an undisclosed upfront payment as well as potential development and regulatory milestone payments and royalties. Ionis will be responsible for IND-enabling toxicology studies and Chinook will be responsible for clinical development and commercialization. © stock.adobe.com/ benschonewillePharma Business International 7 www.pbiforum.net Latest news FibroGen enters into exclusive license for FOR46 with Fortis Therapeutics FibroGen has entered into an exclusive license with Fortis Therapeutics for FOR46, a potential first-in-class Phase 1 antibody- drug conjugate (ADC) targeting a novel epitope on CD46. FOR46 is being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and is being explored for use in other CD46 expressing cancers. As part of the clinical development strategy, FibroGen will continue Fortis Therapeutics’ work to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody (PET46) for patient selection. Under the terms of the agreement, there is no upfront consideration. FibroGen will conduct and fund future research, development, and manufacturing of FOR46 and PET46. During the four-year evaluation period, FibroGen has the option to acquire Fortis Therapeutics for $80 million. In addition, Fortis is eligible to receive up to a total of $200 million based on various regulatory approvals. © stock.adobe.com/ActionGP © stock.adobe.com/thodonal FivepHusion forms strategic collaboration with Treehill Partners and Syneos Health to bring novel, enhanced chemotherapeutic product to market FivepHusion, an advanced clinical-stage biotechnology company, is collaborating with Treehill Partners, a New York-based strategic and financial advisory firm specializing in healthcare industry transactions, and Syneos Health, a fully integrated biopharmaceutical solutions organization, to develop and bring a novel, enhanced chemotherapeutic product to market. Treehill Partners will support FivepHusion with integrated business development, operational, strategic and transactional expertise. Syneos Health will support FivepHusion’s integrated clinical development and commercialization capabilities. This collaboration is designed to strategically and optimally progress development and commercialization of FivepHusion’s enhanced chemotherapeutic formulation Deflexifol in global markets. Dr. Christian Toouli, CEO & Managing Director, FivepHusion, said: “This collaboration represents a unique working model to the industry. Through the combined strength and competency of three industry leaders, we intend to maximize our progress on the development of Deflexifol and quickly bring innovative oncology medicines to patients in need.” Touchlight expands to create one of the world’s largest DNA manufacturing facilities in London Touchlight, a company pioneering enzymatic DNA production, a critical material in many new genetic medicine treatments, has completed the redevelopment and expansion of its UK manufacturing facility, housed in a repurposed Victorian waterworks on the banks of the River Thames. The expanded state-of-the-art facility’s manufacturing capacity has tripled and is now capable of producing more than 8kg a year. This exceeds the current, but growing, global supply of plasmid DNA for genetic medicine. The new facility has 11 suites and includes two class B filling suites with class A filling cabinets, warehousing, together with a quality control laboratory capability and has already received a successful customer quality audit from a Big Pharma company. Jonny Ohlson, Touchlight’s executive chair and founder, said: “Whilst it may not, on the face of it, seem logical to site a GMP manufacturing facility in a waterworks that has been derelict for 70 years, the site has a large footprint of beautiful Victorian buildings which, now converted, provide a stunning and iconic facility that is an inspiring place to work.” © stock.adobe.com/Sergey Nivens European Commission marketing authorization granted for Pedmarqsi Fennec Pharmaceuticals’ Pedmarqsi – known as PEDMARK in the U.S. – has been granted marketing authorization by the European Commission (EC). It is the first and only approved therapy in the EU for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localised, non-metastatic, solid tumors. Further, Pedmarqsi was granted the marketing authorization under the paediatric-use marketing authorization (PUMA) which includes 8 years plus 2 years of data and market protection. “Today’s approval by the EC for Pedmarqsi to help reduce the risk of hearing loss is critical for the approximately four thousand children treated with cisplatin for solid tumors that have not spread,” said Rosty Raykov, CEO of Fennec Pharmaceuticals. “Fennec is proud to bring this safe and effective therapy to the marketplace to mitigate the risk of permanent and irreversible bilateral hearing loss which occurs in approximately 60 percent of children treated with cisplatin and can be as high as 90 percent.” Ultomiris approved in Japan Ultomiris (ravulizumab) has been approved in Japan as the first and only long- acting C5 complement inhibitor for the prevention of relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica. NMOSD is a rare and debilitating autoimmune disease that affects the central nervous system (CNS), including the spine and optic nerves. Most people living with NMOSD experience unpredictable relapses, characterised by a new onset of neurologic symptoms or worsening of existing neurologic symptoms, which tend to be severe and recurrent and may result in permanent disability. Marc Dunoyer, CEO, Alexion, said: “Alexion transformed the NMOSD landscape by uncovering the exceptional efficacy of C5 complement inhibition in reducing the risk of relapses for patients. With today’s approval, we continue to deliver on our commitment to the NMOSD community, offering patients an innovative long-acting treatment option that has the potential to eliminate relapses with convenient dosing every eight weeks. We are proud to expand the reach of Ultomiris as we work to improve patients’ lives around the world.” SKYCovion COVID-19 vaccine authorised by UK’s MHRA SKYCovion, the COVID-19 vaccine developed by SK Chemicals, has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA). It becomes the 8th COVID-19 vaccine authorised by the UK’s independent medicines regulator. The SKYCovion vaccine combines a part of the SARS- CoV-2 virus spike protein with an ‘adjuvant’ – an additional ingredient designed to trigger a stronger immune response. It is given as two injections, four weeks apart. The clinical evidence for this authorisation is based on data from two clinical trials on approximately 3,100 individuals aged 18 to 84 years. The vaccine demonstrated a strong immune response, and the most common side effects were mild, and self-resolved within a few days of vaccination. This authorisation is for use as a primary vaccination in those aged 18 and over. DANYELZA approved in Brazil for the treatment of high-risk neuroblastoma The Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (Anvisa), has granted marketing authorization for Y-mAbs Therapeutics’ DANYELZA (naxitamab-gqgk) 40mg/10mL injection. DANYELZA will be marketed in Brazil by Y-mAbs’ partner Adium Pharma. DANYELZA is a recombinant humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm- derived tumors and sarcomas. DANYELZA is administered to patients three times in a week and the treatment is repeated every four weeks. “Today is an important day for children living with refractory/relapsed high- risk neuroblastoma in Brazil. It’s very exciting to see this treatment approved, creating access to DANYELZA in Brazil from the joint efforts by our partner Adium and the development team at Y-mAbs. We continue to focus on expansion of DANYELZA in other jurisdictions, working to provide access to children living with refractory or relapsed neuroblastoma,” said Thomas Gad, founder, president and interim CEO. BRIXADI extended-release injection receives FDA approval for opioid use disorder The U.S. Food and Drug Administration (FDA) has approved Braeburn’s BRIXADI (buprenorphine) extended-release injection for subcutaneous use (CIII), a new weekly and monthly medication for moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product. BRIXADI is the first and only weekly and monthly subcutaneous injection for moderate to severe OUD and is the only buprenorphine injectable that utilizes FluidCrystal Injection Depot Technology. Patients currently being treated with oral buprenorphine-containing products can be switched to equivalent doses of BRIXADI Weekly or BRIXADI Monthly in accordance with the Prescribing Information for BRIXADI. “Today’s FDA approval of BRIXADI is a significant step forward in the fight against OUD,” said Mike Derkacz, president and CEO of Braeburn. “Over the last three years the US experienced a significant increase in opioid overdoses in part related to the economic and social upheaval that negatively impacted all of us, especially people with opioid use disorder and people in recovery. Additional medication options for opioid use disorder will support healthcare providers in addressing the needs of their patients with opioid use disorder.” 8 Pharma Business International www.pbiforum.netPharma Business International 9 www.pbiforum.net BECKMAN COULTER T he DxI 9000 Analyzer innovations address today’s speed, reliability, reproducibility, quality, and menu expansion demands. The platform has been independently verified to perform at the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) optimal level, the highest level of EFLM performance evaluation. At the same time, the novel Lumi-Phos PRO Substrate has shown the capability to develop increasingly sensitive and clinically relevant assays, ensuring the system is able to meet the healthcare needs of tomorrow. The DxI 9000 Access Immunoassay Analyzer is the most productive immunoassay analyzer per footprint. It can run up to 215 tests per hour per square meter (tests/hr/m2). According to Julie Sawyer Montgomery, President, Beckman Coulter Diagnostics, “The DxI 9000 Access Immunoassay Analyzer sets new expectations for immunoassay testing operational performance and ability to develop and sustain improved assay sensitivity to meet tomorrow’s analytical needs. Those in the laboratory will treasure ZeroDaily Maintenance to save them time, PrecisionVision Technology to safeguard against flawed data reports, and IntelliServe to maximize system uptime. At the same time, clinical researchers are excited about the DxI 9000 Analyzer’s capability to keep pace with increasingly sensitive testing requirements as healthcare providers and pharmaceutical companies take aim at ever more challenging diseases. An inspiring feat of technology, the DxI 9000 Analyzer is a comprehensive healthcare innovation.” An early evaluator of the DxI 9000 Analyzer, Mr. Ray Divilley, Chief Medical Officer, Mayo University Hospital, Ireland, added, “With the DxI 9000, Beckman Coulter has successfully produced a platform that addresses today’s laboratories needs for speed, accuracy, and reliability. Based on our use and evaluation of the system in our lab, we were able to get actionable results back quicker to doctors and ultimately patients as they consider treatment options.” ZeroDaily Maintenance highlights the embedded innovations that drive the DxI 9000 Analyzer’s uptime performance. Beta users attest to ZeroDaily Maintenance redefining their workday with no daily maintenance requirements, thereby reducing annual maintenance routines by up to 96%. Building on Beckman Coulter’s workflow and automation leadership, PrecisionVision Technology is unmatched in its ability to inspect, identify and prevent erroneous reporting in real time. PrecisionVision automated safeguards include tube identification, cap detection, tip check, sample aspiration, and delivery, residual wash volume, and substrate volume. Each check reduces the risk of reporting flawed data and increases system reliability and reproducibility. The newly designed remote service and diagnostics solution, DxS IntelliServe, connects with DxI 9000 Analyzers to monitor data and error trends, enabling timely, proactive system service when needed. Beckman Coulter’s Access NT-proBNP assay measures concentrations of N- terminal pro B-type natriuretic peptide that originate in a person’s heart. High levels of natriuretic peptides can indicate heart failure. Access NT-proBNP provides rapid results in less than 11 minutes and increases accuracy in diagnosing heart failure with age-based cutoffs and disease-specific comorbidity data for improved test result interpretation. Beckman Coulter Unveiled the DxI 9000 Access Immunoassay Analyzer at EuroMedLab in Rome Next >