biologics

Merck & Co. Breaks Ground on $1 Billion Biologics Center in US

Merck Wilmington Biotech will serve as a launch and commercial production facility and the future US home for Keytruda.

Syngene Acquires its First US Manufacturing Facility

Syngene, a global contract research, development, and manufacturing organization (CRDMO), recently announced the acquisition of its first biologics site in the USA – fitted with multiple monoclonal antibody (mAbs) manufacturing lines.

AstraZeneca to Invest $3.5 Billion in the US

Anglo-Swedish drugmaker AstraZeneca plans to invest $3.5 billion in the US to expand the company’s research and manufacturing footprint by the end of 2026.

Specialty Pharma CDMO OneSource Recently Launched

OneSource Specialty Pharma, a newly incorporated CDMO, formed from the merger of three CDMO businesses within the Strides Group. The company has a 30-year track record and specializes in biologics, drug-device combinations, and soft gelatin capsules.

Lilly Announces New $4.5 Billion Site

Eli Lilly and Company (Lilly) recently announced a $4.5 billion (€4.07 billion) investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development.

Insights into Biologics and Pharmaceutical Manufacturing

Bill Humphries, CEO of Alcami, shares his vision for the future, discussing dynamic market trends and the company’s commitment to innovation. Under his leadership, Alcami is poised to redefine the pharmaceutical and biotechnology landscape, focusing on cutting-edge solutions and navigating global complexities. This conversation highlights Alcami’s strategic direction, accomplishments, and upcoming challenges.

The CDMO/CMO Report

Driven by increased demand in biologic-based drugs, biologic drug substance manufacturing continues to be an active area of investment by contract development and manufacturing organizations/contract manufacturing organizations (CDMOs/CMOs), including several multi-billion large-scale biomanufacturing projects. What companies are expanding, and where do these expansions stand?

​​Lonza Completes Expansion of Microbial Manufacturing Facility

Lonza recently announced that it has completed a planned expansion of the mid-scale microbial manufacturing facility at its Visp, Switzerland site. This multi-product facility was recently granted a GMP license, allowing cGMP manufacturing and release of biologics produced using microbial fermentation.

Agilent to Buy Canadian CDMO Biovectra for $925 Million

Santa Clara, CA-based Agilent Technologies has signed a definitive agreement to acquire specialized contract development and manufacturing organization Biovectra from H.I.G. Capital in a move to expand its end-to-end biopharma solutions.

Kyowa Kirin to Establish New Biologics Manufacturing Plant in US

Kyowa Kirin announced a new, state-of-the-art manufacturing facility in Sanford, North Carolina, US. Kyowa Kirin will invest up to $530 million (€489 million) in constructing a 15,951m2 two-bioreactor facility, scheduled to break ground in Q3 of 2024.

Aurigene Opens Biologics Facility

Aurigene Pharmaceutical Services Limited (Aurigene), a Dr. Reddy’s Laboratories Limited company, inaugurated its biologics facility spread across 6500 m2 (70,000 sq ft) in Hyderabad, India.

Sanofi Invests €1 Billion to Boost Drug Manufacturing in France

On Monday, Paris-based French drugmaker Sanofi announced plans to invest more than €1 billion at three facilities in France to create new bioproduction capacity.

Aragen Launches First Phase of Biologics Facility in India

Aragen, a CRDMO, has launched the first phase of its biologics manufacturing facility in Bangalore, India. The $30 million project, executed by its subsidiary Aragen Biologics Pvt Ltd, has completed its first small-scale manufacturing project for a US-based organization, producing a novel anticancer monoclonal antibody.

Kyowa Kirin to Build First US Pharma Operations

Japan-based pharmaceutical company Kyowa Kirin plans to build a $200 million biologics manufacturing center in Sanford, North Carolina, creating 102 jobs. This will be the company’s first North American pharmaceutical manufacturing operation, expected to create 102 jobs.

AbbVie to Build New Biologics Manufacturing Site in Singapore

Last week, AbbVie broke ground on a new Singapore manufacturing facility located in Singapore's Tuas Biomedical Park. The company will invest $223 million in the site which will add 24,000 l of biologics drug-substance capacity to AbbVie's global manufacturing network and support current products as well as emerging immunology and oncology compounds within its pipeline.

Aragen to Invest $30 Million in a New Indian Bio-Manufacturing Site

Aragen, an India, Hyderabad-headquartered contract research development and manufacturing organization (CRDMO) for small molecules and biologics, plans to set up a new biologics manufacturing facility in Bangalore, India.

Quality and Safety in Biopharmaceutical Production

The biopharmaceutical industry is experiencing a drive towards biologic products due to their promise as treatments for chronic diseases.

New Biologics and Advanced Therapies

The pharmaceutical market is undergoing a profound transformation, driven by innovation among biologics and advanced therapies (ATs). This shift is not only redefining the treatment landscape but also presenting new opportunities and challenges related to the drug development and manufacturing value chain.

Wuxi Biologics Plans Spin-off and Separate Listing of Wuxi XDC

Chinese contract research, development, and manufacturing organization (CRDMO) Wuxi Biologics announced the planned spin-off and separate listing of its subsidiary WuXi XDC on the Hong Kong Stock Exchange. Upon completion of the proposed listing, Wuxi XDC will remain a consolidated subsidiary.

Siegfried Demonstrates Biologics Expertise in Hameln

The Fill & Finish of biologic drugs is expensive and poses special technological challenges for CDMOs. At the German site in Hameln, Siegfried has successfully proven these capabilities over the past two years by producing Covid-19 vaccines and a significant number of clinical batches for several biological companies. By investing in its competencies, capacities and flexibility, the company intends to further expand this demanding but promising business area.

Sandoz Builds Biologics Plant in Slovenia

Sandoz, the generics and biosimilars arm of Swiss drugmaker Novartis, has signed a Memorandum of Understanding to build a biologics production plant in Lendava, Slovenia.

Genentech Builds Biologics Facility in California

Genentech, the US biotech arm of Swiss pharma giant Roche, is building a new small-batch biologics manufacturing facility at its Oceanside campus in California, USA. Groundbreaking took place on Feb. 10.

Ramping Up Biomanufacturing Capacity

Biomanufacturing for both traditional biologics and new modalities, such as cell and gene therapies, continues to be an active area of investment for CDMOs/CMOS. Some of the major investments by the larger CMDOs/CMOs are outlined in this article.

Managing Supply for Complex Biotherapeutics

Successfully managing the drug substance manufacturing of Antibody-Drug Conjugates (ADCs) requires a sophisticated understanding of the technological development process and access to a range of large- and small-molecule manufacturing assets.

Thermo Fisher and Innoforce Plan Chinese JV

US scientific equipment manufacturer Thermo Fisher Scientific and China-based CDMO Innoforce have formed a joint venture to own and operate a new pharma services facility for integrated biologics and sterile drug development and manufacturing in Hangzhou, China. Start date for the new entity is 2022.

Catalent Appoints Kay Schmidt as Senior Vice President of Technical Operations

Catalent Invests $200 Million on Biologics

Catalent Biologics Restructures Biologics Business

Addressing Challenges in Sterile Manufacturing

Novartis to Close US Generics Unit, Keep Roche Stake

Lonza Buys Shire US Site

Catalent Pays $950 Million for Cook Pharmica

Samsung Bioepis and Takeda in Biologics Pact

Sanofi and Lonza to Build Biologics Plant

Catalent Starts Madison Expansion Project