Author Archives: Dan Stanton

Amgen: Not treating biosimilars as ‘stepchild’ is key to success

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Amgen says using the same development expertise and manufacturing capabilities for both its biosimilar and novel biologic programs sets it apart in the industry. Pharma firm Amgen is one of a handful of firms that has successfully invested in both innovator products and biosimilars – biologics that are very similar to reference biologics and for which there are no clinically meaningful differences in terms of safety, purity, and potency. With expected 2021 biosimilar revenues set to reach $2 billion, CEO…

January 10, 2022

British American Tobacco launches plant-based biotech KBio

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The UK-headquartered biotech will combine British American Tobacco’s plant-based technology capabilities with subsidiary Kentucky BioProcessing. In 2020, Kentucky BioProcessing (KBP), the wholly owned subsidiary of the Big Tobacco firm British American Tobacco (BAT), entered the race to develop a COVID-19 vaccine. Development of the candidate is ongoing, but the program, will now fall under the arm of KBio Holdings Limited (KBio), a newly launched biotech incorporating the two entities. “It’s a new company, which essentially incorporates KBP activities and aims…

January 10, 2022

Catalent hit with FDA 483 at Belgian fill and finish facility

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A syringe filling facility in Brussels run by CDMO Catalent has received a US FDA Form 483 and has allegedly created supply issues for Novo Nordisk’s Wegovy. The 265,000 square-foot site described as Catalent’s flagship European syringe filling facility produces over 175 million units annually for the contract development and manufacturing organization’s (CDMO’s) customers. But a recent inspection by the US Food and Drug Administration (FDA) discovered concerns at the site and resulted in a Form 483. “We are treating…

January 7, 2022

Thermo Fisher buys recombinant protein maker PeproTech for $1.85bn

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Thermo Fisher has opened its M&A war chest early in 2022, buying biopharma reagent firm PeproTech for $1.85 billion. The deal, announced on December 30, closed yesterday, adding Cranbury, New Jersey-based reagent maker PeproTech to Thermo Fisher Scientific’s cell culture media offering. Founded in 1988, PeproTech offers over 2,000 cytokines, antibodies, ELISA, and cell culture media kits for the development and manufacturing of biologics and cell and gene therapies. According to Thermo Fisher’s CEO Marc Casper, the acquisition “will be…

January 6, 2022

New year, new gene therapy plants from Pfizer and Expression

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Christmas came early for Pfizer and Expression Therapeutics, which cut the ribbons on viral vector manufacturing plants in North Carolina and Ohio, respectively. Pfizer’s gene therapy division celebrated the new year with an expanded manufacturing footprint, having opened the first of three facilities at its site in Durham, North Carolina on December 15. The 85,500 square-foot plant will support clinical manufacturing of Pfizer’s gene therapy pipeline and represents an investment of $68.5 million by the firm. The facility will create…

January 4, 2022

Bioanalytics booster: Sartorius takes stake in Automated Lab Solutions

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Sartorius has acquired 62.5% of cell isolation firm Automated Lab Solutions (ALS) with the remaining shares set to be purchased in 2026. Jena, Germany headquartered ALS is the latest investment in bioanalytics by life sciences firm Sartorius. The deal, announced late last year, adds solutions for the automated analysis, selection and isolation of cells to Sartorius’ offerings, and adds around 30 people to its staff. Gerry Mackay, member of the Executive Board and Head of the Lab Products & Services…

January 4, 2022

Novartis to boost gene therapy pipeline through $800m Gyroscope buy

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Novartis will add a gene therapy candidate in Phase II trials for an advanced form of dry age-related macular degeneration through the addition of Gyroscope Therapeutics. Novartis will gain GT005, an Adeno-Associated Virus-2 (AAV)-based gene therapy candidate intended to be a one-time treatment for geographic atrophy (GA) – an advanced form of dry age-related macular degeneration (AMD) that leads to progressive and irreversible vision loss – through the proposed acquisition. Novartis is one of the leaders in the gene therapy…

January 4, 2022

Flurry of biopharma cyber-attacks driven by COVID

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Non-profit organization BIO-ISAC has called for drugmakers to review their cybersecurity after disclosing an attack targeting a biomanufacturing facility earlier this year. BIO-ISAC, an organization launched in August to provide early-warning and education of digital biosecurity threats, announced an undisclosed biomanufacturer was involved in an advanced persistent threat (APT) attack named Tardigrade in Spring 2021. “Through the subsequent investigation, a malware loader was identified that demonstrated a high degree of autonomy as well as metamorphic capabilities. In October 2021, further…

December 16, 2021

‘Incredible demand’ for talent leaving gaps throughout bio-outsourcing space

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Pharma recruitment firm Lead Candidate says a perfect storm of factors has contributed to a shortage of professionals across key functions, and the pandemic has only made recruiting more difficult. Business across the pharma and bio-outsourcing space is robust, whether at third-party manufacturing companies, contract research organizations (CROs), or pharma services firms. However, such a vigorous environment means the need for skilled staff has never been higher, creating something of a bottleneck going forward. Life sciences talent sourcing firm Lead…

December 9, 2021

BrainStorm’s cell therapy: Catalent high on NurOwn supply

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BrainStorm Cell Therapeutics is eying the potential launch of NurOwn and has selected CDMO Catalent to produce the autologous cell therapy from its site in Texas. Known as NurOwn, MSC-NTF is cell therapy candidate being investigated in Phase III trials for Amyotrophic Lateral Sclerosis (ALS) by BrainStorm. The potential therapy is made from bone marrow-derived mesenchymal stem cells (MSCs) taken from the patient, which are expanded and differentiated ex vivo before being converted into MSC-NTF cells that secrete high levels…

December 8, 2021