Your guide to the pharmaceutical world Volume 13 Issue 1 Pumps and fluids Optimising pumping Microbiology and R&D The microbial question Sorting and weighing Key for quality and safety Pumps and fluids Optimising pumping Microbiology and R&D The microbial question Sorting and weighing Key for quality and safety www.pbiforum.net NTERN NATION AL Fut pro Fut ture fi g coding bility ce g Labelling, c and traaceab Food scienc Environmen spotlight ntal agingkc aa P rld o our guide to the pharmaceutical wY Issue 4 1olume 1 V mpeeee T profitable Sustainable, ature er bl a Unyielding i contro em l ll a Handlingth handli M net www .pbiforum.ne SEPTEMBER 2023 EAST MIDLANDS LEA £3.50 EADING BUSINESS MAGA AZINE een going gr WW The business case eo DMS Comms, Collab WW the barriers Organisatio bs and ANDSBUSINE rstoexceence ning - onal lear ESSLNKCOU w UK .co.uk www EMPOWER Your Business T OCTOB £2.95 BER2023 BreastC Hair & B Cce Bty WithLou In Love Month Awaren B th BLM GROUP www.blmgroup.co.uk Heritage Lincolns hi WWW.LINCWWW.LINC OLNSHIRETOOLNSHIRETO ODAYNEODAYNE september 2023 yorkshire & lincolnsh £3.50 shire’s leading business ma magazine VOLUME38SSUE09 .blmgroup.co.ukwww organ c Over Automation driving adaption success Driving business ning isational lear comngbaeso V w Often Imitated - Never Equalled www.blmgroup.co.uk8 12 16 24 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) 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-up8 2025 has begun with a flurry of significant acquisitions in the pharmaceutical industry. Laboratories12 AI-powered drug discovery systems in labs are dominating the market. Microbiology and R&D16 Microbiology in the lab has always been time consuming, but new advents in technology could solve some of those problems. Pumps and fluids20 Pipes, vats, and vessels, pumps are to a factory what the veins and arteries are to a human body – safely containing and moving around the ingredients often vital to a pharma business. Sorting and weighing24 Sorting and weighing are crucial in developing and manufacturing safe and effective pharmaceuticals. Health, safety and hygiene28 Is health and safety an area that can be delegated to AI? No, but also maybe yes… Events 32 We give a rundown of pharma events happening around the world. @pbiforum www.pbiforum.net company/pbiforum Cover photo courtesy: stock.adobe.com/pwmotion4 Pharma Business International www.pbiforum.net Latest news ACG expands global footprint with new capsule manufacturing facility in Thailand ACG, a global supplier of integrated manufacturing solutions for the pharmaceutical and nutraceutical industries, has announced the commencement of operations at its state-of-the-art capsule manufacturing facility in Rayong, Thailand. The new facility, the largest of its kind in Thailand, is dedicated to the production of empty hard gelatin capsules and is strategically located to serve key markets across Asia. This facility is set to play a pivotal role in ACG’s global operations, increasing the company’s capacity to meet the growing demand for high-quality capsules in the region. In addition to Thailand, countries such as Indonesia, Vietnam, South Korea, Malaysia, and the Philippines will benefit from shorter transit times and enhanced supply chain efficiencies. The 175,000-square-meter facility will employ 250 people and is designed to produce 20 billion capsules annually. ACG also aims to secure approvals to supply capsules to China from this facility, further extending its regional reach. FDA orphan drug and rare pediatric disease designations granted to Arbor Biotechnologies’ primary hyperoxaluria type 1 treatment The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) and rare pediatric disease designation (RPDD) to Arbor Biotechnologies’ ABO-101 for the treatment of primary hyperoxaluria type 1 (PH1). The designations closely follow the FDA’s clearance of the investigational new drug (IND) application for the novel gene editing therapeutic in December 2024. PH1 is a rare genetic kidney disease associated with an overproduction of oxalate that often presents in children, causing kidney stones, kidney damage, and eventual kidney failure. “ABO-101 receiving rare pediatric disease and orphan drug designations from the FDA for the potential treatment of PH1 underscores the urgent need for novel treatment options,” said Dan Ory, M.D., Chief Medical Officer of Arbor Biotechnologies. “As Arbor advances ABO-101 into the clinic with the initiation of the redePHine Phase 1/2 clinical study, these designations reinforce the potential of ABO-101 to deliver lasting disease modification as a first-in-class gene editing therapy for PH1.” Relmada Therapeutics acquires potential Tourette syndrome therapy from Asarina Pharma Relmada Therapeutics, a clinical-stage biotechnology company, has acquired Sepranolone, a Phase 2b ready neurosteroid, from Asarina Pharma, being developed for the potential treatment of Tourette syndrome (TS) and other compulsive disorders. Sergio Traversa, Chief Executive Officer of Relmada, said: “We are very pleased to announce this agreement with Asarina. Sepranolone aligns with our Company’s mission to find solutions for difficult-to-treat central nervous system (CNS) disorders. There is a serious unmet need for improved TS therapies not only reducing tics but also improving quality of life without serious side effects. “We have been impressed by the encouraging Phase 2a efficacy signal with clinically meaningful tic reductions and quality-of-life improvements, combined with a robust safety data package showing no CNS off-target effects, that we believe reflect the compound’s selective binding properties. “We believe that this transaction is an excellent fit with our objective to build shareholder value by leveraging our core competencies of identifying and developing innovative compounds.” © stock.adobe.com/K.A./Andrii © stock.adobe.com/K.A.SewcreamStudioPharma Business International 5 www.pbiforum.net Latest news Amazon Filters launches high-temp vent filter for pharma and biotech A UK process filter manufacturer has launched an enhanced high-temperature-resistant membrane product aimed at vent applications across the global pharmaceutical and biotechnology markets. Amazon Filters’ SupaPore TMB is specifically designed for hot operating conditions in processes such as sterile air venting and large-scale fermentation. It is ideally suited for use in vent housings such as on WFI (water for injection) tanks or fermentation inlet air where filters are subject to continual high temperatures from heating jackets. Key features of SupaPore TMB include polyphenylene sulphide membrane support and drainage layers, which provide robust resistance to oxidative and ozonated environments. SupaPore TMB cartridges are made in an adhesive-free, thermal bonding process. Each unit is pre-flushed with ultra-pure water and integrity-tested before final assembly to meet the highest industry standards. The product comes with bubble point, diffusional flow and water intrusion values to validate the filters and system, and it can be steam-sterilised multiple times. A unique identification mark on each cartridge ensures traceability. © stock.adobe.com/K.A./Corona Borealis Ultra-Hygienic mixing at small-scale Introducing the new 150 UHS Ultra-Hygienic Small-Scale In-Line mixer from Silverson Machines. The 150 UHS In-Line is designed for Ultra Hygienic applications typically encountered in the pharmaceutical and biotech industries, where the smallest production scale mixers may be too large, but laboratory equipment might not offer sufficient capacity. This model is built to the same high specification as production scale UHS mixers and is supplied with Silverson- designed hygienic single mechanical shaft seals, which can be converted to hygienic double mechanical shaft seals suitable for pressurised flush. They have crevice-free construction and are designed for Clean-In-Place (CIP) and Sterilise-In-Place (SIP) operation. Ideal for batches of up to 50 litres, the mixer features a range of interchangeable workheads and screens, offering intense yet targeted high shear capability. The rotor/stator workhead is impossible to bypass, so all material is subjected to high shear as it passes through the workhead. The mixer can be supplied with data dossier documentation packages conforming to all regulatory standards, for example, cGMP, FDA and EC1935/2004. The 150 UHS can be supplied with a Vessel Package, increasing the versatility and flexibility of the mixer. The Vessel package comprises of a 50 litre vessel, vessel stand, valve and pipework. The model can also be converted to a Multi-stage 088/150 which increases the number of shearing actions per revolution of the rotor, resulting in substantially faster mixing times and increasing the number of products that can be processed in a single pass. To find out more visit www.silverson.co.uk Dr. Reddy’s enters into collaboration with Henlius for commercialization of HLX15 Dr. Reddy’s Laboratories has entered into a license agreement with Shanghai Henlius Biotech for the commercialization of HLX15, Henlius’ investigational daratumumab biosimilar candidate to Darzalex & Darzalex Faspro. HLX15 is a recombinant anti-CD38 fully human monoclonal antibody injection, with intravenous as well as subcutaneous formulations. HLX15 is being developed as a biosimilar of Darzalex & Darzalex Faspro, which are indicated for the treatment of multiple myeloma. The agreement combines Dr. Reddy’s global commercial presence with Henlius’ proven capabilities in developing biosimilars for markets worldwide. Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply, and may receive up to a total of $131.6 million, including an upfront payment of $33 million and milestone payments. In addition, Henlius is eligible to receive royalties on annual net sales of the product. Dr. Reddy’s gets exclusive rights to commercialize the subcutaneous as well as intravenous formulations of HLX15 in the United States (U.S.) and Europe. 6 Pharma Business International www.pbiforum.net Latest news Orion and Invenra to develop innovative bispecific antibody cancer therapeutics Orion and Invenra have entered into a research collaboration to discover bispecific antibodies using Invenra’s B-Body platform. Under the terms of the agreements, Invenra will leverage its B-Body bispecific antibody platform from monoclonal antibody discovery to optimized panels of bispecific leads. Orion will be responsible for the selection of targets and will be solely responsible for the development, manufacturing, and global commercialisation of these candidates. The agreement provides Orion with commercial licenses for up to two bispecific antibodies. “Partnering with Invenra represents an important step in Orion’s strategy to expand our portfolio in the bispecific antibody space,” said Antti Haapalinna, Vice President, Head of External Science & Partnering R&D, Orion. “Invenra’s cutting-edge bispecific discovery platform, combined with Orion’s expertise in development and commercialisation, will accelerate the creation of impactful new therapies for patients worldwide.” “This collaboration highlights the strength and versatility of our B-Body® platform in addressing complex biological challenges,” said Roland Green, CEO of Invenra. “We are thrilled to work with Orion, a company that shares our commitment to delivering innovative therapies that address critical unmet medical needs.” Beacon granted FDA Regenerative Medicine Advanced Therapy designation for X-linked retinitis pigmentosa treatment The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ophthalmic gene therapy company Beacon Therapeutics’ laru-zova (laruparetigene zovaparvovec) for the treatment of X-linked retinitis pigmentosa (XLRP). RMAT designation was created to expedite the development and review of regenerative medicine therapies that have the potential to address unmet need in serious or life-threatening diseases, based on preliminary clinical evidence. RMAT designation provides benefits including interactive communications with the FDA throughout development, the opportunity to discuss appropriate endpoints to support accelerated approval, and eligibility for expedited programs such as priority review. The FDA’s RMAT designation for laru-zova recognizes preliminary clinical evidence from the Phase 2 DAWN and SKYLINE trials evaluating the efficacy, safety and tolerability of laru-zova in patients with XLRP caused by mutations in the RPGR gene. This evidence includes emerging data from DAWN showing improvements in low luminance visual acuity (LLVA), which provides support for the measure as a clinically meaningful endpoint in XLRP. Vanda Pharmaceuticals and AnaptysBio announce global license agreement for Generalized Pustular Psoriasis treatment Vanda Pharmaceuticals and AnaptysBio have announced an exclusive, global license agreement for the development and commercialization of imsidolimab (IL-36R antagonist mAb), which has successfully completed two registration-enabling global Phase 3 trials, GEMINI-1 and GEMINI-2, evaluating the safety and efficacy of imsidolimab in patients with Generalized Pustular Psoriasis (GPP). GPP is a rare skin disorder often caused by mutations in the IL36RN gene that codes for a regulatory protein that balances the activity of the proinflammatory IL-36 family of cytokines. Dysregulation of this balance in IL-36 signaling leads to severe chronic skin inflammation with pustules and systemic symptoms which carry significant morbidity and mortality often associated with sepsis and multi-organ failure. Imsidolimab inhibits the function of the IL-36R, compensating for the deficiency of the endogenous IL-36 regulator in patients with GPP. Imsidolimab has successfully concluded its development program in GPP, including the GEMINI-1 and GEMINI-2 global Phase 3 studies. In 2025, Vanda intends to initiate and complete the technology transfer activities and will immediately begin preparing the BLA and MAA applications for the US and EU and making preparations for commercialization. © stock.adobe.com /Alpha Tauri 3D © stock.adobe.com/Dr_Microbe © stock.adobe.com/ peopleimages.com Valneva receives marketing authorization in UK for chikungunya vaccine The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the UK for the world’s first chikungunya vaccine, IXCHIQ. Valneva’s single-dose vaccine is indicated for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older. The approval is based on IXCHIQ’s final pivotal Phase 3 data, published in The Lancet, which included more than 4,000 participants and demonstrated that a single dose of the live-attenuated IXCHIQ vaccine induces a rapid and strong immune response. Data has since shown this response can be maintained for at least three years in both younger and older adults. The UK approval marks the fourth regulatory approval Valneva has received for its single-shot chikungunya vaccine. The vaccine is currently approved in the United States, Europe and Canada in adults 18 years of age and older. Valneva expects to receive marketing approval in Brazil in the first quarter of 2025, which would represent the first approval in an endemic country. European Commission authorises ViiV Healthcare’s long-acting injectable Vocabria + Rekambys for HIV treatment in adolescents The European Commission has authorised ViiV Healthcare’s Vocabria (cabotegravir long-acting injections) in combination with Johnson & Johnson’s Rekambys (rilpivirine long-acting injections) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed. As of 2023, there were 1.55 million people aged 10 to 19 around the world living with HIV; people in this age bracket typically have lower reported treatment coverage, adherence to treatment and viral suppression rates than older age groups. Cabotegravir and rilpivirine long-acting reduces the number of doses needed for effective HIV treatment from 365 daily pills to as few as six injectable treatments per year and helps alleviate challenges with daily oral treatments, including stigma and adherence-related stress, in clinical trials and observed in real-world studies. Harmony P. Garges, M.D., Chief Medical Officer at ViiV Healthcare, said: “This authorisation for Vocabria + Rekambys is an important milestone for adolescents living with HIV across Europe who may prefer a long-acting HIV treatment that could address challenges with taking daily oral regimens and could better suit their individual needs.” U.S. FDA approves Celltrion’s AVTOZMA, a biosimilar to ACTEMRA The U.S. Food and Drug Administration (FDA) has approved Celltrion’s AVTOZMA (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to ACTEMRA. AVTOZMA is indicated for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19). “Introducing both IV and SC formulations of AVTOZMA provides flexibility and a wider range of treatment options,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers. Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs.” RYSTIGGO, for generalized myasthenia gravis, receives EU approval for two new administration methods UCB, a global biopharmaceutical company, has announced the CHMP (Committee for Medicinal Products for Human Use) has issued a positive opinion for the self-administration of RYSTIGGO (rozanolixizumab) via an infusion (syringe pump) or a new manual push syringe method, after training from a healthcare professional. In the EU, rozanolixizumab is indicated as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive. “For people living with gMG, unpredictable symptoms can have a significant impact on daily life, leading to patients feeling vulnerable and lacking control. Subcutaneous self-administration may help address these challenges, enhancing patient autonomy and satisfaction by reducing the need for frequent clinic visits,” said Donatello Crocetta, Chief Medical Officer and Head of Global Medical Affairs, UCB. “We welcome the EU approval for self-administration of rozanolixizumab in Europe, marking another significant step forward in our ongoing commitment to improving the lives of people living with gMG.” Takeda’s FRUZAQLA gains Health Canada market authorization for metastatic colorectal cancer Health Canada has provided market authorization for Takeda Canada’s FRUZAQLA (fruquintinib capsules), indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are not considered candidates for available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti- VEGF agent, an anti-EGFR agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib. FRUZAQLA works by helping to stop tumors from making new blood vessels and therefore slowing down the growth of cancer. The authorization is based on data from two large Phase 3 trials: the multi-regional FRESCO-2 trial, data from which were published in The Lancet, along with the FRESCO trial conducted in China, data from which were published in JAMA. In both trials, FRUZAQLA plus best supportive care demonstrated significant improvements in overall survival, with corresponding improvements in progression free survival, versus placebo plus best supportive care. www.pbiforum.netPharma Business International 7M&A ROUND-UP 8 Pharma Business International www.pbiforum.net I n a year of geopolitical uncertainty and regulatory challenges, 2024 saw the life sciences industry turn away from major mergers and acquisitions to focus on bolt-ons and other smaller strategic plays, as highlighted in the 2025 edition of the EY Firepower report. Pharma firms targeted earlier-stage assets, tapping into innovation at an earlier point in the development cycle, instead of investing multi-billions to acquire de-risked, market-ready assets. This resulted in a fall in deal value, though volume remained stable. As we settle into 2025, there are “strong structural reasons to expect a return to dealmaking,” as the EY Firepower report states. Indeed, the industry still holds high levels of dealmaking Firepower, still faces an approaching wave of patent cliffs, while acquisitions remain core to growth, with the majority of leading company revenues coming from products derived from deals. Boding well for the year ahead, there have been a number of significant transactions so far in 2025. Johnson & Johnson - Intra-Cellular Therapies Johnson & Johnson is to acquire Intra-Cellular Therapies, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, for a total equity value of approximately $14.6bn. With the agreement, Johnson & Johnson adds Intra-Cellular Therapies’ CAPLYTA (lumateperone), a once-daily oral therapy approved to treat adults with schizophrenia, as well as depressive episodes associated with bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive therapy with lithium or valproate. In December 2024, Intra-Cellular Therapies announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for CAPLYTA as an adjunctive treatment for adults with major depressive disorder (MDD). In two global, double-blind, placebo-controlled Phase 3 studies, CAPLYTA, as an adjunctive treatment to antidepressants, demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms, as measured by both clinician-rated and patient-reported outcomes. Further Phase 3 trials are underway with CAPLYTA in bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania). “Building on our nearly 70-year legacy in neuroscience, this unique opportunity to add Intra- Cellular Therapies to our Innovative Medicine business demonstrates our commitment to transforming care and advancing research in some of today’s most devastating neuropsychiatric and neurodegenerative disorders,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “This acquisition further differentiates our portfolio, serves as a strategic near- and long-term growth catalyst for Johnson & Johnson and offers compelling value to patients, health systems and shareholders.” A new year of dealmaking 2025 has begun with a flurry of significant acquisitions in the pharmaceutical industry. 10 ÁPharma Business International 9 www.pbiforum.net M&A ROUND-UP © stock.adobe.com/volody10Next >