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【EXPERT Q&A】What are the implementation standards for DCS systems of pharmaceutical companies?

Drugdu.com expert’s response: DCS (Distributed Control System) is the core automation system in pharmaceutical manufacturing, requiring adherence to three critical objectives: compliance, data integrity, and system reliability. Below is a detailed breakdown based on international regulations, industry practices, and technical requirements: I. International Regulations & Industry Standards GMP Compliance FDA 21 CFR Part 11: Mandates electronic records and signatures, ensuring DCS data storage, modification, and audit trails meet regulatory standards. EU GMP Annex 11: Focuses on computerized system validation, including access control, data backup, and cybersecurity. ICH Q9/Q10: Risk-based quality systems requiring DCS to identify Critical Process Parameters (CPPs) and mitigate quality risks. GAMP 5 Guidelines: Classifies DCS as Category 4 (Configurable Software), requiring full lifecycle validation (URS, FAT, SAT, IQ/OQ/PQ). ISO Standards ISO 9001: Ensures quality management for DCS suppliers. ISO 27001: Protects DCS from cyber threats via information security protocols. II. Technical & Functional Requirements Data Integrity (ALCOA+ Principles) Traceability: Full operational ...
- Source: drugdu
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- March 26, 2025
400 billion yuan, Johnson&Johnson announces big move

Johnson & Johnson to Invest $55 Billion in U.S. Healthcare Infrastructure By Thomas Yuan WILSON, N.C. — In a sweeping move to reinforce America’s life sciences sector, Johnson & Johnson announced on March 21 that it will invest more than $55 billion in its pharmaceutical and medical technology business across the United States over the next four years — a 25 percent increase from its previous investment cycle. The investment, the company said, aims to bolster U.S. manufacturing, research and development, and innovation in fields like oncology, neuroscience, and robotic surgery. It comes as part of a broader effort to maintain America’s global leadership in medical supply and health products, at a time when governments are emphasizing domestic production in response to geopolitical tensions and lessons learned from the pandemic. “We are committed to addressing the world’s toughest healthcare challenges,” said Joaquin Duato, Chairman and CEO of Johnson & Johnson, ...
- Source: drugdu
- 72
- March 25, 2025
The self rescue record of Solventum

Solventum Undertakes $120 Million Overhaul in Strategic Bid for Growth By Thomas Yuan ST. PAUL, Minn. — Solventum, the healthcare spin-off of industrial giant 3M, has entered a new chapter of independence with a bold restructuring effort aimed at reshaping its organizational DNA and strengthening its position in the global medical technology landscape. The company has spent $120 million on its transformation plan — but expects to recoup the entire amount in annual operating cost savings. In a recent investor briefing, Solventum reported that the savings generated in the first year alone will be “sufficient to cover the incremental expenses” of its operations as a newly public company. “This restructuring is not just about cost,” said a company spokesperson in an interview with The Star. “We are optimizing strategic resource allocation to drive long-term business expansion. Our Minnesota-based workforce continues to grow.” From Legacy to Leadership The restructuring, which ...
- Source: drugdu
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- March 25, 2025
AstraZeneca announced a $2.5 billion investment plan to build a new strategic R&D center in Beijing

AstraZeneca to Establish $2.5 Billion R&D Hub in Beijing, Expanding Vaccine and Biotech Partnerships By Thomas Yuan BEIJING — AstraZeneca has unveiled a sweeping $2.5 billion investment plan to build its sixth global strategic research and development center in Beijing, a move that underscores the pharmaceutical giant’s long-term commitment to China’s life sciences sector and its ambitions in biopharmaceutical innovation. The new facility will serve as a cornerstone for AstraZeneca’s expansion in China, with the company also announcing several high-profile partnerships aimed at advancing next-generation drug development and vaccine production. Among the newly signed agreements, AstraZeneca has entered into R&D cooperation with Hebo Pharmaceuticals to pursue multi-specific antibody therapies, as well as a development collaboration with Yuansisheng Peptide focused on macrocyclic peptide drugs, a cutting-edge category of targeted therapies. In addition, the company has launched a joint venture with Kangtai Biological, which will focus on the development, production, and commercialization ...
- Source: drugdu
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- March 25, 2025
Zhifei Biotech invested 593 million yuan to acquire Chen’an Biotech and enter the field of metabolic disease medicine

Zhifei Biotech Acquires Majority Stake in Chen’an Bio to Expand into Therapeutic Biopharmaceuticals By Thomas Yuan CHONGQING — Zhifei Biotech has announced a strategic acquisition to broaden its footprint beyond vaccines and into the realm of therapeutic biopharmaceuticals, investing 593 million yuan (approximately $82 million) to acquire a 51 percent stake in Chen’an Biotech, a Chongqing-based pharmaceutical company focused on metabolic diseases. The deal, finalized on March 21, marks a key milestone in Zhifei’s goal to become a world-class biopharmaceutical company, enabling the firm to diversify its product pipeline and tap into high-growth therapeutic areas like diabetes and obesity. According to an asset appraisal report, the pre-investment valuation of 100 percent of Chen’an Biotech was set at 570 million yuan. Under the agreement, 471 million yuan of Zhifei’s investment will be allocated to Chen’an’s registered capital, while the remaining 122 million yuan will go toward the company’s capital reserves. Upon ...
- Source: drugdu
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- March 25, 2025
Taking the “pass” to the global market and anchoring the 10 billion blue ocean, AIM’s mRNA herpes zoster vaccine has been approved by the United States for clinical trials

AIM Vaccine Gains U.S. FDA Approval for mRNA Shingles Vaccine Trial By Thomas Yuan BEIJING — AIM Vaccine has received approval from the U.S. Food and Drug Administration to begin clinical trials for its mRNA herpes zoster vaccine, the company announced on March 23, marking another major step in its global expansion and bolstering its position as China’s mRNA vaccine pioneer. The new shingles vaccine demonstrated superior performance in preclinical trials, with T cell immunity, IgG antibody titers, and FAMA titers significantly outperforming an internationally available recombinant subunit vaccine, according to third-party testing agencies. The approval is the second green light from the U.S. FDA for AIM’s mRNA pipeline, following the earlier clearance of its mRNA RSV vaccine. With a growing portfolio that includes mRNA candidates for influenza, rabies, and respiratory illnesses, AIM has signaled its intent to compete on the international stage by leveraging its modular mRNA platform — ...
- Source: drugdu
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- March 25, 2025
Clover Biopharmaceuticals RSV Candidate Vaccine Clinical Trial Approved by FDA

Clover Biopharmaceuticals Launches U.S. Trial for RSV Booster Vaccine SCB-1019 By Thomas Yuan CHENGDU — Clover Biopharmaceuticals has received investigational new drug (IND) approval from the U.S. Food and Drug Administration for its RSV vaccine candidate, SCB-1019, the company announced on March 24. The first batch of elderly participants has already been enrolled in a Phase I clinical trial to evaluate the safety and immunogenicity of SCB-1019 as a booster vaccine for respiratory syncytial virus. The trial will recruit up to 160 subjects between the ages of 60 and 85, all of whom had previously received GSK’s AREXVY, the leading approved RSV vaccine, at least two seasons prior. Participants will be randomized to receive either a heterologous booster dose of SCB-1019, a homologous booster of AREXVY, or a placebo. The study aims to assess safety, reactogenicity, and immune response in the context of repeat vaccination. The company’s approach leverages a ...
- Source: drugdu
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- March 25, 2025
CPhI Worldwide

CPhI Worldwide 2025 to Convene in Frankfurt, Spotlighting Global Pharmaceutical Innovation By Thomas Yuan FRANKFURT — The world’s premier pharmaceutical ingredient exhibition, CPhI Worldwide 2025, will be held from October 28 to 30 at the Congress Centre Frankfurt, located at Ludwig-Erhard-Anlage 1, 60327 Frankfurt am Main, Germany. Organized by Informa Markets, the event is expected to draw thousands of global professionals across the biopharmaceutical, medical technology, and health product sectors. Since its launch in 1990, CPhI Worldwide has evolved into the most influential platform for sourcing active pharmaceutical ingredients (APIs), exploring innovative drug formulations, and networking across the international medical supply chain. This year’s edition continues the tradition of excellence, offering a comprehensive showcase of breakthrough technologies and next-generation therapeutics. Diverse Product Categories Covering the Full Pharma Spectrum The exhibition will feature a wide array of products and services, spanning the entire pharmaceutical ecosystem: APIs: Including vitamins, hormones, analgesics, ...
- Source: drugdu
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- March 25, 2025
The clinical trial of the world’s first oncolytic virus product based on the M1 skeleton of the hepatitis A virus, originally created by China, has completed its first administration at Zhongshan Third Hospital

China Launches First Clinical Trial of Intravenous Oncolytic Virus Therapy VRT106 By Thomas Yuan GUANGZHOU — On March 19, 2025, researchers at the Third Affiliated Hospital of Sun Yat-sen University announced a key milestone in the development of VRT106, the world’s first oncolytic virus therapy based on the M1 skeleton of the hepatitis A virus. The Phase I clinical trial has officially begun, with the first patient enrolled and dosed via intravenous injection, showing no adverse reactions or infusion-related events. Jointly led by Professor Peng Liang and Professor Xie Chan from the Department of Infectious Diseases, and Professor Dong Min from Oncology, the trial marks the initial human validation stage for this novel biopharmaceutical designed to treat a range of advanced solid tumors, including liver cancer, colon cancer, triple-negative breast cancer, and cervical cancer. Precision-Targeted Therapy With Dual Anti-Cancer Action Developed by Guangzhou Weilunte Pharmaceutical Technology Co., Ltd. (Weilunte), ...
- Source: drugdu
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- March 24, 2025
Junshi Biotech’s first ADC dual drug has been approved for clinical use, with the potential to be widely effective in treating tumors while overcoming drug resistance

Junshi Biotech Advances Dual-Target ADC Therapy JS212 into Clinical Trials By Thomas Yuan SHANGHAI — Junshi Biotechnology announced yesterday that it has received official approval from China’s National Medical Products Administration to begin clinical trials for JS212, a novel antibody-drug conjugate (ADC) targeting two key cancer receptors: EGFR and HER3. The investigational drug marks the company’s first dual-drug ADC to enter the clinical phase and signals a major milestone in its pipeline of innovative oncology therapies. JS212 is a recombinant humanized bispecific antibody conjugate, designed to treat advanced malignant solid tumors such as lung cancer, breast cancer, and head and neck cancers. These tumor types often exhibit high co-expression of EGFR and HER3, which are known to drive cancer proliferation, migration, and resistance to existing therapies. “JS212 represents an important step forward in our pursuit of precision oncology,” Junshi said in its statement. “Its bispecific targeting could offer broader therapeutic ...
- Source: drugdu
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- March 24, 2025

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