US FDA accepted Sandoz Biologics License Application for proposed biosimilar denosumab

Excerpt The submission is supported by comprehensive analytical and clinical data packages. Denosumab indicated for treating variety of conditions including osteoporosis in postmenopausal women1,2. Sandoz will continue to build biosimilars portfolio to increase patient access to high-quality therapies and support healthcare system sustainability.   Article Summary  Sandoz, a global leader in off-patent (generic and biosimilar) […]

U.S. biologics CDMO, Bionova Scientific of the Asahi Kasei Group, expands manufacturing capacity

Article Summary   Asahi Kasei Medical’s U.S. subsidiary Bionova Scientific, a full-service biologics CDMO, has decided to expand its process development and GMP biologics manufacturing capacity.   Under the Asahi Kasei Group’s medium-term management plan (MTP) for fiscal 2024 focused on the theme “Be a Trailblazer”, the bioprocess business of Asahi Kasei Medical is one […]

Solution Group Berhad to Start Local Fill and Finish of CanSinoBIO’s COVID-19 Vaccine in Malaysia

Article Summary   CanSino Biologics Inc. and Solution Biologics Sdn Bhd (“SOLBIO”), a wholly owned subsidiary of Solution Group Berhad, jointly announced that the first shipment of the active pharmaceutical ingredients (“APIs”) of CanSinoBIO’s Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (“Ad5-nCoV”, trade name: Convidecia®) in bulk form has arrived in Malaysia.    The […]

Lonza Completes Expansion of Conjugation Facility in Visp (CH)

Excerpt The expansion adds development and manufacturing capacity for pre-clinical, clinical and commercial supply of bioconjugates and antibody-drug conjugates Two manufacturing suites and supporting infrastructure are involved in the Visp (CH) investment   Article Summary Lonza, announced that a planned expansion of its bioconjugation facility in Visp (CH) is completed. Two manufacturing suites and supporting […]

Pfizer announces $750M investment to expand SW Michigan facility

Article Summary Pfizer announced on Monday it is investing $750 million to expand its Southwest Michigan pharmaceutical facility.   The company says the Modular Aseptic Processing (MAP) Phase 2 expansion will create 300 jobs. Officials say the facility near Kalamazoo, where Pfizer first mass produced its COVID-19 vaccine, will advance its sterile manufacturing technology. It […]

Global Pharma Giants Partner Singapore Researchers To Boost Innovation In Biologics And Vaccines Manufacturing

Excerpt GlaxoSmithKline, Sanofi and Takeda will partner with research communities from the Agency for Science, Technology and Research (A*STAR); National University of Singapore (NUS); Nanyang Technological University, Singapore (NTU Singapore) and its innovation and enterprise company, NTUitive; and Singapore Institute of Technology (SIT) to boost Singapore’s biologics manufacturing capabilities. Article Summary Leading pharma companies GSK, […]

Fujifilm Invests $188 Million in New Cell Culture Media Manufacturing Facility 

Excerpt Fujifilm’s fifth media manufacturing site to be operated by FUJIFILM Irvine Scientific. It triples the company’s current capacity for liquid cell culture media production and creates over 100 new positions, including bioprocessing engineers, manufacturing, production, and logistics roles. Article Summary FUJIFILM Corporation announced a $188 million investment to establish a cell culture media manufacturing […]

Biocon Biologics Completes Acquisition of Viatris’ Global Biosimilars Business

Excerpt Biocon Biologics completes the multi-billion-dollar, value accretive transaction in part-equity and part-cash, including: Upfront cash payment of USD 2 billion Issuance of CCPS worth USD 1 billion of Viatris and creates a unique, fully integrated, leading global biosimilars enterprise with eight commercialized products.  Article Summary Biocon Biologics Ltd., a subsidiary of Biocon Ltd. announced […]

WuXi Biologics Released a New cGMP Drug Product Manufacturing Facility to Support End-to-End Services for Diversified Modalities

Excerpt With further capacity and capability for drug product fill & finish, WuXi Biologics provides global customers with end-to-end integrated solutions for diversified modalities, including mRNA-LNP. Article Summary WuXi Biologics announced its new drug product (DP) facility, named DP8 – located in Hangzhou, China, has completed the first batch of GMP manufacturing. The DP8 facility […]

PharmaEssentia breaks ground on Hsinchu plant

Article Summary   PharmaEssentia Corp (藥華醫藥), which provides drugs for a rare type of blood cancer, broke ground for a new factory in Hsinchu, which is scheduled to be completed in 2025. The plant is expected to boost the company’s annual production value by NT$40 billion (US$1.25 billion), executives from the firm said at the […]

GSK opens first high-potency facility in Singapore to produce drugs for cancer treatment

Excerpt GSK invested S$44m t in the new high potency manufacturing facility and laboratory further strengthening Jurong site capabilities to launch new products more quickly. This facility will  manufacture a key ingredient for antibody drug conjugates (ADCs). Article Summary GSK officially opened its first high-potency manufacturing and test facility in Jurong, Singapore with the capability […]

BioNTech Expands Global Footprint by Acquiring GMP Manufacturing Site to Establish First mRNA Facility in Singapore

Excerpt BioNTech’s first mRNA manufacturing facility in Singapore is expected to be fully operational in late 2023 and will create regional manufacturing capacities in support of BioNTech’s growing pipeline of mRNA-based vaccines and therapeutics across Asia Pacific region for both clinical and commercial scale. Article Summary BioNTech announced its Singapore affiliate BioNTech Pharmaceuticals Asia Pacific […]