All Biologics formulation and stability articles – Page 7
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NewsPatent expiration to drive biosimilars market expansion to 2032
Cost effectivity of biosimilars is predicted to be a key contributor to growth of the global biosimilar market to 2032, research states.
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NewsInnovative personalised immunotherapy approved for multiple myeloma
Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
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NewsThe role of outsourcing in antibody drug manufacture
While manufacturing capacity was a major challenge in early development of monoclonal antibody drugs (mAbs), outsourcing to CDMOs likely helped to remedy this, research reports.
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NewsAntibody-immunotherapy treatment shows benefit in serious endometrial cancer
The novel combination cancer therapy facilitated “exceptional” responses in some patients enrolled in a Phase II study for endometrial cancer.
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NewsADC oncology acquisition to address solid tumours
The acquisition will give Genmab worldwide rights to three clinical candidates including a potential best-in-class folate receptor alpha (FRα)-targeted ADC for ovarian cancer.
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NewsCHMP meeting highlights: March 2024
At the Committee for Medicinal Products for Human Use (CHMP)’s March meeting, twelve medicines received positive opinions for marketing authorisations, including a new antibiotic and a novel oral medicine for a rare blood disorder.
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NewsAstellas breaks ground on new facility
Astellas’ new €330 million manufacturing facility in Tralee, Ireland will make pharmaceuticals, including antibody drugs.
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ArticleDeveloping new treatment regimens for HIV
Here, Sherene Min, Vice President and Head of Global Clinical Development at ViiV Healthcare, explains how the HIV treatment landscape is changing, with moves towards long acting and self‑administered treatments.
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NewsSandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
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NewsCHMP meeting highlights: February 2024
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
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NewsSingle-use technology propelling upstream bioprocessing market expansion
A driving factor behind the expansion of the upstream bioprocessing market is the need for process improvement in the biopharma industry, research highlights.
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NewsOvercoming challenges of continuous antibody manufacture
During monoclonal antibody (mAb) manufacture, continuous flowsheets could offer ~20 percent–40 percent cost of goods (COG) saving over the batch process, for instance, during low commercial demand, a paper suggests.
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Webinar
Process analytical technology: applications and opportunities for pharma
During this virtual panel, industry experts will discuss the latest advances and applications of process analytical technology in the pharmaceutical sector.
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WhitepaperWhitepaper: Unique Particle Sizes via Spiral Jet Mills
Discover how combining a spiral jet mill with an in-line classifier optimizes particle size distribution in pharmaceuticals, enhancing drug efficacy.
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NewsBCMA CAR T therapy facilitates potential autoimmune breakthrough
First use of a BCMA CAR T-cell therapy for immune-mediated necrotising myopathy (IMNM), enabled sustained depletion of autoantibodies beyond 18 months, a study shows.
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NewsNICE recommends injectable bispecific antibody for aggressive blood cancer
Recommendation of AbbVie’s bispecific antibody for NHS use is based on a Phase I/II trial, which observed a 62 percent overall response rate in diffuse large B-cell lymphoma (DLBCL) patients.
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Whitepaperebook: Filling gaps in managing large volumes of biologics
Aseptic aliquotation and cryopreservation of bulk drug substances are crucial process steps in bioprocessing that require an efficient process.
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NewsMedicines for Europe calls for simpler SPC manufacturing waiver
To ensure timely market entry of generics and biosimilars in the EU, the Supplementary Protection Certificate (SPC) Manufacturing Waiver must be clearer, asserts Medicines for Europe.
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WhitepaperWhitepaper: What Are Some Hidden Risks Associated with Isolators?
Uncover the pivotal role of isolator technology in enhancing safety and productivity in the pharmaceutical and chemical industries.
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NewsWill new therapeutic agent replace antibodies for bacterial detection?
Aptamers offer a “cutting-edge approach” for identifying gram-negative bacterial pathogens, a paper suggests.