Author Archives: Dan Stanton

Encroaching titer, hidden danger: Upstream intensification and the downstream mess

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Increased titers are driving the need to move to semi and fully-continuous processing in the downstream, UCB’s Stefanos Grammatikos told BPI Europe delegates. In efforts to intensify bioprocesses and accelerate development, industry has traditionally looked to increasing titers. Since the early days of biomanufacturing thirty years ago, titers have risen from less than 0.5 g/L to mid-to-high single-digits. However, some firms claim they are able to drive titers far higher, either through the use of non-mammalian expression systems (in the…

April 11, 2019

ChromaCon buy and expansions tip YMC further into the biologics space

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Japanese separation resins firm YMC has acquired ChromaCon AG, adding a range of continuous chromatography technologies to its ever-increasing large molecules purification portfolio. The deal, financials of which have not been released, saw YMS acquire 100% of ChromaCon shares and intellectual property rights. This includes patents around multi-column processing, the Contichrom benchtop instrument range of products and several license arrangements. “YMC Process Technologies already manufactures and markets GMP production skids embedding ChromaCon technology,†Philipp Anstätt, strategist aligning R&D and market…

April 10, 2019

Celltrion jumps into ADC space through Canadian partnership

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Celltrion has inked a deal with iProgen Biotech to develop a pipeline of antibody-drug conjugates (ADCs). While best known for its portfolio of marketed biosimilars, Korean drugmaker Celltrion has been investing in its internal R&D for novel biotherapeutics and has five antibodies in development for diseases ranging from rabies to influenza. Now the firm is aiming to develop up to four antibody-drug conjugates (ADCs), including one targeting breast cancer, through a partnership agreement with Canadian firm iProgen Biotech. Financial details…

April 10, 2019

RNAi: Regeneron pumps $800m into ‘potentially game-changing science’

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Regeneron will look to develop RNA interference (RNAi) therapeutics for eye and CNS diseases by teaming with and investing in Alnylam Pharmaceuticals. RNA interference (RNAi) therapies are a new class of drugs that work by inhibiting gene expression or translation by neutralizing targeted mRNA molecules. The first – and only – commercial RNAi therapy is Alnylam’s Onpattro (patisiran), approved by the US Food and Drug Administration (FDA) last August for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis…

April 9, 2019

Sangamo ‘excited’ about Thermo’s takeover of CDMO partner Brammer

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Sangamo Therapeutics has secured access to large-scale AAV manufacturing through long-term partner Brammer Bio, a gene therapy CDMO set to be bought by Thermo Fisher. Sangamo Therapeutics has several gene therapy candidates moving through the clinic, including its own programs for inherited metabolic diseases and partnered programs in hematology with Pfizer and Sanofi. To support these, the firm has broadened out its manufacturing strategy by securing access to large-scale adeno-associated virus (AAV) manufacturing through an option agreement with contract development…

April 8, 2019

Freeze company: Orchard reformulating HSC gene therapies

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Orchard Therapeutics says it is launching a cryopreserved formulation of its lead candidates to overcome the limitations of fresh hematopoietic stem cell gene therapies. Orchard Therapeutics’ pipeline includes Strimvelis, the former GSK autologous ex vivo hematopoietic stem cell (HSC) gene therapy approved by the EMA in 2016, along with five clinical stage programs. The firm launched its initial public offering (IPO) last year and in its first public year-end financial conference call last week spoke of the potential upcoming milestones…

April 5, 2019

Samsung Bio to make $1bn worth of CytoDyn’s HIV antibody

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CytoDyn has contracted Samsung BioLogics to produce the drug substance for its candidate leronlimab and says it will need at least two CMOs once the HIV inhibitor is approved. CytoDyn’s lead candidate leronlimab (PRO 140) has demonstrated antiviral activity and shown to significantly reduce viral burden in people infected with HIV in Phase II clinical trials. The fully humanized IgG4 monoclonal antibody blocks the predominant HIV (R5) subtype entry into T-cells by masking the required co-receptor, CCR5. The firm has…

April 5, 2019

Quality FBS, or just BS? Industry turning to supply chain certification

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Fetal bovine serum (FBS) is the gold standard for growth media but poor quality and counterfeit product pose risks to manufacturing and the patient. Traceability audits and origin determination test can overcome these, says the ISIA. FBS has been used as a culture supplement for the past 65 years and is unlikely to be rivalled in its growth promoting capabilities for some time, Brian Lewis, a representative from the International Serum Industry Association (ISIA) and president of BL Consulting, told…

April 3, 2019

‘Aging’ biotech AgeX to build Cali cell therapy plant

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AgeX Therapeutics will construct a cGMP laboratory facility in Alameda, California to manufacture cell lines and its biological aging cell-based product candidates. The biotech firm announced in an SEC filing that it has entered into an agreement to lease 23,911 square feet of space in Alameda, California. The space will be used as AgeX’s principal offices and research laboratory, but the firm also intends to construct a cGMP laboratory facility for the manufacture of cell lines and its cell-based product…

April 3, 2019

Novartis grabs AstraZeneca’s CO plant and staff for AveXis gene therapy

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Novartis has acquired a biomanufacturing facility – earmarked for closure by AstraZeneca – ahead of the potential launch of AveXis’ gene therapy for spinal muscular atrophy, Zolgensma. Since Novartis bought AveXis for $8.7 billion (€7 billion) in May 2018, the Swiss pharma giant has rapidly grown its gene therapy manufacturing network. The latest action sees the firm add the 700,000 square-foot Longmont facility to its AveXis operations in what it says is preparation for the launch of Zolgensma (onasemnogene abeparvovec-xioi1),…

April 2, 2019