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Articles by Nice Insight
Coriolis Pharma Launches U.S. Entity Alongside Innovative Drug Product Platform Service Offerings for Monoclonal Antibodies
Martinsried-Munich, Germany, May 29, 2024 – Coriolis Pharma, a globally operating service provider for R&D and GMP drug product development, R&D and GMP analytics and sterile drug product manufacturing support, announced the launch of a U.S. entity that allows customers to combine the convenience of a local service with the advantages of international expertise.
How Synergistic Collaborations Between Outsourcing Partners Can Accelerate Clinical Success
Before initiating human trials for a pharmaceutical product, there is a crucial need to invest in chemistry, manufacturing, and controls (CMC) development to ensure the clinical product meets established quality manufacturing criteria. The main goal of CMC is to ensure the quality of the pharmaceutical product throughout its development stages.
PCI Pharma Services Begins Installation of Sterile Fill-Finish and Lyophilization Line as Part of $100 Million New Facility Expansion
Philadelphia, PA – PCI Pharma Services, (“PCI”) a world leading global contract development and manufacturing organization (CDMO), has begun installation of key equipment for its newest sterile fill-finish facility on the company’s Bedford, NH campus.
Leading CDMO PCI Pharma Services Releases Inaugural Comprehensive ESG Report
Philadelphia, PA – PCI Pharma Services, (“PCI”) a leading global contract development and manufacturing organization (CDMO), has released its first Environmental, Social & Governance (ESG) Report. A detailed overview of PCI’s multifaceted sustainability journey, the report showcases the strides taken from the program’s formal inception in 2021 through its 2023 fiscal year, and lays out ambitious goals for continued progress along multiple fronts.
Antheia and Olon Continue Partnership for Biomanufacturing Antheia’s Pipeline of KSMs and APIs for Essential Medicines
Menlo Park, CA and Milan, Italy – Antheia, the pharmaceutical ingredient manufacturer transforming essential medicine supply chains and Olon Group, the global leader in developing and manufacturing active pharmaceutical ingredients (APIs) for CDMO (contract development and manufacturing organization) and generic markets, today announced an ongoing partnership to leverage Olon’s vast fermentation infrastructure to manufacture Antheia’s early products.
List Biotherapeutics and Sacco System Announce Lead Share Agreement
Indianapolis, Ind., and Yeerongpilly, Queensland, Australia, March 14, 2024 – List Biotherapeutics, Inc. (List Bio) and Sacco System Australia Pty Ltd (Sacco) today announced a lead share agreement to introduce and mutually recommend each other’s microbial development and manufacturing services to prospective customers if one party discovers a project that is better suited to the other party’s capability or capacity. No intellectual property will be exchanged between the companies.
Genezen Announces Strategic Process Development and Manufacturing Partnership Agreement with Seattle Children’s Research Institute for X-linked Agammaglobulinemia (XLA) Cell Therapy Program
FISHERS, IN. – March 6, 2024 – Seattle Children’s Research Institute, the research division of Seattle Children’s Hospital and renowned global leader in pediatric research, and Genezen, a leading gene and cell therapy contract development and manufacturing organization, have unveiled a strategic manufacturing partnership for Seattle Children’s Research Institute’s X-linked agammaglobulinemia (XLA) program.
NMDP Announces Enrollment of First Patient in OPTIMIZE Clinical Trial
MINNEAPOLIS, MINN. – NMDPSM (formerly known as the National Marrow Donor Program), home to the most diverse blood stem cell and marrow donor registry in the world, announced the enrollment of the first patient in the groundbreaking OPTIMIZE clinical trial today. The trial is sponsored by NMDP through the Center for International Blood and Marrow Transplant Research (CIBMTR®).
Right from the Start: Designing Advanceable Formulations and Processes at Phase I
Accelerating the development of a candidate drug from discovery to commercialization by even a single year can bring breakthrough therapies to individuals with limited treatment options, especially if this candidate addresses an unmet medical need.
Genezen Enters Licensing Agreement with CSL for the Cytegrity™ Stable Lentivirus Production System
FISHERS, IN. and BOSTON, MA – Feb. 21, 2024 – Genezen, a leading cell and gene therapy Contract Development and Manufacturing Organization (CDMO), today announced licensing of the Cytegrity™ proprietary stable production system from biotechnology leader CSL. Cytegrity™ is an advanced inducible stable producer technology designed for the production of lentiviral vectors (LVVs).
Revolutionizing Early-Stage Biopharma Development: Introducing Wheeler Bio's Portable CMC™ Platform
Although the druggable target universe continues to expand for biopharmaceutical developers, R&D costs are rising at a time when downward pricing pressures are also increasing, and expectations are heightened for measurably improved efficacy for new products compared with those already on the market. Being first to market with cost-effective, highly differentiated medicines is imperative to the success of not only the individual programs but the biopharma developers themselves.
Expanding Capabilities for Clients:Olon to Open New High Potency API Suite in US
Milan, Italy - Olon Group announces the construction of a cutting-edge High Potency API suite. A GMP High Potency Active Pharmaceutical Ingredient (HPAPI) suite, currently under construction at the Olon USA site in Concord, Ohio, the center of excellence for early development of APIs within the Olon Group.
Suanfarma unifies its industrial brands in a rebranding initiative under Suanfarma CDMO
Madrid, Spain: Suanfarma, a prominent leader in the B2B life science business, announces a strategic rebranding initiative. All of this is aimed at reinforcing the importance of Suanfarma as a global player in the healthcare sector, both as a distributor of APIs and as a CDMO company in the production of active pharmaceutical ingredients. In this manner, Suanfarma´s sites, Cipan and Rovereto, are now acknowledged as part of a global and unified brand.
2024 Market Insight, CDMO Pricing and Benchmarking
Make better decisions with our pricing and benchmarking report Discover the mammalian cell culture contract development and manufacturing market with our comprehensive study on top CDMOs and insights into manufacturing trends. Benchmark your business with our in-depth pricing studies, which use years of primary data, to see how to best position your business. Dive into the focus on production of antibodies and antibody-based therapeutics.
Microbial Fermentation, Biologics: 2024 Market Insight, CDMO Pricing and Benchmarking
Essential CDMO market intelligence and pricing data Unlock the biologics market with insights into manufacturing trends and a comprehensive study of the top CDMOs specializing in microbial fermentation of therapeutics. Benchmark your business from development to manufacture with our in-depth pricing studies, which use years of primary data. Our Market Insight report provides unique analyses into biologics produced in microbial cell culture, such as cytokines and growth factors.
2024 Market Insight, CDMO Pricing and Competitor Benchmarking
Scientific analysis of pDNA and Advanced Therapeutics Stay up to date with market trends for plasmid DNA (pDNA) as both a reagent for advanced therapies and as a primary therapeutic. Our Market Insight report provides essential market intelligence from innovators, CDMO owners, PhDs and researchers across advanced therapeutics to fully understand plasmids’ role in advanced therapeutics.
Gene Therapy: 2024 Market Insight, CDMO Pricing and Competitor Benchmarking
Exclusive CDMO pricing data for benchmarking Measure your business against your peers using our robust analysis of the gene therapy contract development and manufacturing market. Our pricing matrix comprises material cost, infrastructure and development process data from CDMOs all over the world so you can make informed decisions to best position your business. Comprehensive overview of the gene therapy landscape in 2024, including information on AAV, Lentiviral and non-viral gene therapies.
Cell Therapy: 2024 Market Insight, CDMO Pricing and Competitor Benchmarking
Exclusive CDMO pricing data for benchmarking Measure your business against your peers using our robust analysis of the cell therapy contract development and manufacturing market. Our pricing matrix comprises material cost, infrastructure and development process data from CDMOs all over the world so you can make informed decisions to best position your business.
2023 Market Insight, CDMO Pricing and Competitor Benchmarking
Over 80 significant CDMO profiles including capabilities, capacity, proprietary technologies and locations
Cell & Gene Therapy: 2023 Market Analysis, CDMO Pricing and Competitor Benchmarking
Scientific analysis on ATMPs — The New Frontier Stay up to date with market trends for Cell and Gene Therapies straight from the industry’s KOLs. Our Market Analysis gains insights from CDMO owners, PhDs and researchers across advanced therapeutics. Measure your business against your peers using our robust analysis of AAV, lentiviral and plasmid DNA manufacture. Our pricing matrix uses data from across the industry so you can make informed decisions for your business.
SGD Pharma Announces the Appointment of Fabio Invernizzi, General Manager West Business Unit
Paris La Défense, FRANCE: SGD Pharma, global primary glass packaging leader, has announced the appointment of Fabio Invernizzi as its new General Manager of its West BU. The BU West includes SGD Pharma’s commercial activities for MEA, North and South America and our manufacturing footprint in Europe. Fabio joins the Group Executive Committee bringing over 15 years of experience in Commercial, Marketing and Business Development at a senior level for the life science industry.
Vetter becomes a member of the German Association of Research-Based Pharmaceutical Companies (vfa)
Ravensburg, January 17, 2024: Vetter, a leading globally operating contract development and manufacturing organization (CDMO), has joined the German Association of Research-Based Pharmaceutical Companies (vfa) as an associate member. With this membership, the vfa recognizes the significant role that the pharmaceutical service provider plays in the field of complex injectable drugs.
Why Fina Biosolutions Partnered With Scorpius BioManufacturing for cGMP Production of EcoCRM® (CRM197)
The FinaBio team spent months evaluating CDMOs before choosing Scorpius as a long-term manufacturing partner. The search for a CDMO was especially challenging since they are a “not-for-much profit” company, a phrase coined by FinaBio’s founder and CEO Dr. Andrew Lees. “The biopharmaceutical industry is increasingly focused on COGS when it comes to cell and gene therapies, but there is still a lot of work that needs to be done to make well-established technologies more affordable,” Lees said.
Vetter joins Science Based Targets Initiative
Ravensburg, Germany. December 5, 2023: Vetter, a leading globally operating Contract Development and Manufacturing Organization (CDMO), has joined the Science Based Targets Initiative (SBTi) membership group as of November 2023. The goal of the companies in the SBTi is to achieve climate neutrality by 2050, thus representing the strictest climate protection targets for companies worldwide. As a result, Vetter has committed to the 1.5 degrees of global warming target.
Alloy Therapeutics and Wheeler Bio Announce Preferred Service Offering for Alloy Partners to Accelerate the Translation from Discovery to CMC
Boston, Mass. & Oklahoma City, Okla.— Alloy Therapeutics, Inc., a biotechnology ecosystem company and Wheeler Bio Inc, an agile contract development and manufacturing organization (CDMO), announced today the formation of a non-exclusive, preferred service offering to drive translation from Discovery to CMC development and clinical material supply for ecosystem partners.
Samsung Biologics and Kurma Partners Announce Strategic Partnership for Development and Manufacturing of Biologics for Kurma’s Portfolio Companies
Incheon, South Korea, Paris, France, Munich, Germany – Samsung Biologics (KRX: 207940.KS), a global contract development and manufacturing organization (CDMO), and Kurma Partners, a European venture capital firm in healthcare and biotechnology, today announced a strategic partnership for the development and manufacturing of biologics for Kurma Partners’ portfolio companies.
Digitalization, AI, and Automation Lead Pack of Advances Fueling Life Sciences Industry Growth, New CRB Report Finds
KANSAS CITY, Missouri – Across the vast global life sciences supply chain, data, digitalization, automation, and artificial intelligence are telling complex and compelling stories about how we move vital vaccines, therapies and cures to patients. Are we ready to listen?
Vetter looks ahead to further expansions to meet supply chain demand
Ravensburg, Germany: Vetter, a leading global Contract Development and Manufacturing Organization (CDMO), announces additional investments as part of its long-term dedication to customer partnerships. Vetter’s extensive 40+ years of experience in aseptic filling and packaging shows a consistent desire for sustainable growth and corporate development.
Piramal Pharma Solutions Launches In-Vitro Biology Capabilities at Ahmedabad Discovery Services Site
- Multi-million dollar investment augments in-vitro biology capabilities in primary and secondary screening - Expansion couples new biology services with existing chemistry capabilities - Brings added value to customers by providing an integrated set of discovery capabilities to the market Mumbai, India : Piramal Pharma Limited’s Pharma Solutions (PPS) business, a leading Contract Development and Manufacturing Organization (CDMO), today formally announced the launch of a world-class...
Be The Match BioTherapies® and Cryoport Partner to Accelerate the Development of Cell and Gene Therapies
Partnership will provide access to standardized and optimized apheresis collection, cryopreservation and bioprocessing processes throughout the U.S. and Europe MINNEAPOLIS, Minn. and NASHVILLE, Tenn.
AGC Biologics Completes pDNA and mRNA Expansion at Heidelberg location
CDMO increases manufacturing capacities for plasmid DNA (pDNA) and messenger RNA (mRNA) projects at Plasmid Center of Excellence. Today, we announced the completion of the facility expansion for our new plasmid DNA (pDNA) and messenger RNA (mRNA) production line at our Heidelberg, Germany site. With this expansion and added production line, AGC Biologics can now offer more plasmid material in high-quality and GMP grades and extend the services for mRNA supply.
Wheeler Bio Announces Grand Opening of Biomanufacturing Facility
Boston, Mass. & Oklahoma City, Okla.— Wheeler Bio, a contract development and manufacturing organization (CDMO) for next-gen protein therapeutics, announced today the grand opening of their state-of-the-art drug substance Current Good Manufacturing Practices (CGMP) facility inside the Ziggurat building (Echo Investment Capital) in Oklahoma City, OK.
What Piece of Conventional Industry Wisdom Do You Think is Misguided, Outdated, or Just Plain Wrong?
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research.
Redesigning ANDA or Novel Drug Products at All Stages for the U.S. Market
Biotech startups form through two main channels: spinouts from academia, where technology developers establish their companies, and organizations created by venture capital (sometimes with involvement from big pharma) using technology licensed from academic groups.
How Is Your Organization Currently Leveraging Real-World Data/Evidence and What Uses Do You Anticipate in the Future?
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research.
Addressing the Evolving Nitrosamine Contamination Issue
Nitrosamines (or N-nitrosamines) are chemical compounds with the structure R2N−N=O that include a nitroso group (NO+) bonded to a deprotonated amine, and where R is typically an alkyl group. Many members of this class of compounds have been shown to exhibit carcinogenic and mutagenic effects in animal models at several different tissue sites and by several different routes of exposure.
DeltaTrak’s FlashTrak Global Supply Chain Management System Ready for Sweden’s Export-Oriented Economy
Pleasanton, Calif. ─ Sweden can now rely on the patented FlashTrak® Global Chain of Custody (CoC) information management system from DeltaTrak, a Silicon Valley-based technology innovator of cold chain and supply chain management solutions, to help keep its growing export-oriented economy strong.
Webinar: A Developer's Guide to Partnering With the Right CDMO, Presented by Samsung Biologics
In this co-sponsored webinar brought to you by Samsung Biologics and Pharma's Almanac, Daniel Buckley of Samsung Biologics presents on current dynamics in the CDMO market and key attributes that differentiate the strongest outsourcing partnerships. Watch the full webinar to gain valuable industry insights.
Webinar: Capitalizing on CDMO Expertise in Aseptic Fill/Finish, Presented by Samsung Biologics
From optimized tech transfer, to expedited batch release, to a team culture of expertise, David King, Director of Drug Product Operations at Samsung Biologics, will discuss pivotal moments in past projects and how Samsung Biologics leverages its CDMO expertise to meet accelerated timelines in aseptic fill/finish manufacturing.
Wheeler Bio Appoints Marc Helouin as Chief Quality and Regulatory Officer
BOSTON and OKLAHOMA CITY – Wheeler Bio, Inc., an agile, boutique, clinical contract development and manufacturing organization (CDMO) today announced the appointment of Marc Helouin as Chief Quality and Regulatory Officer (CQRO).
US Food and Drug Administration (FDA) Purchase the LiFT System from DIANT® Pharma INC.
July 24th, 2023 - Manchester, CT - DIANT® Pharma Inc. is excited to announce the US Food and Drug Administration’s recent acquisition of the DIANT® LiFT system. The DIANT® LiFT system (https://diantpharma.com/the-diant-lift-system/) is GMP-capable equipment designed for the continuous manufacturing of lipid and polymer-based nanoparticles.
Fina Biosolutions Selects Scorpius BioManufacturing for Production of cGMP CRM197
San Antonio, TX (USA) –Fina Biosolutionshas selectedScorpius BioManufacturing, a biologics contract development and manufacturing organization (CDMO), for the production of an E.coli-expressed CRM197 conjugate vaccine carrier protein.
Q1. In what areas of pharma/biopharma are you most excited to see increased adoption of artificial intelligence (AI) and machine learning?
Ed Roullard, SVP of Marketing, Operations, and IT, Actylis The potential use cases for AI applications in the pharma space are seemingly only limited by the creativity of the industry. If news stories are correct, billions of dollars have already been invested within the industry to bring AI to reality. We envision three different impacts.
Q2. How is an increased focus on patient-centric concerns influencing the way that you work?
Michael Moussourakis, Vice President of Strategy, Alconox, Inc. A significant majority of our customers are from regulated industries producing drugs, manufacturing and reprocessing medical devices, cleaning healthcare instruments, performing laboratory analyses, and similar activities, all of which of course directly impact patients. The pandemic helped remind industries that cleaning must precede disinfection.
Q2. How is an increased focus on patient-centric concerns influencing the way that you work?
Michael Moussourakis, Vice President of Strategy, Alconox, Inc. A significant majority of our customers are from regulated industries producing drugs, manufacturing and reprocessing medical devices, cleaning healthcare instruments, performing laboratory analyses, and similar activities, all of which of course directly impact patients. The pandemic helped remind industries that cleaning must precede disinfection.
In what areas of pharma/biopharma are you most excited to see increased adoption of artificial intelligence (AI) and machine learning?
The potential use cases for AI applications in the pharma space are seemingly only limited by the creativity of the industry. If news stories are correct, billions of dollars have already been invested within the industry to bring AI to reality. We envision three different impacts.
Be The Match BioTherapies® Marks Cord Blood Awareness Month with the Announcement of the Cord Blood Bank Alliance
The Be The Match BioTherapies Cord Blood Bank Alliance will work to grow the use of cord blood as a starting material to advance the development of live-saving cell therapies. MINNEAPOLIS, Minn. July 10, 2023 — In recognition of Cord Blood Awareness Month, Be The Match BioTherapies®, an organization offering solutions for companies developing and commercializing cell and gene therapies, today announced the formation of the Be The Match BioTherapies Cord Blood Bank Alliance (CBBA).
Wheeler Bio Appoints Dr. Stewart McNaull as Chief Business Officer
Dr. Stewart McNaull will help drive Wheeler Bio’s mission to rapidly advance biologics programs through its innovative Portable CMC™ technology. BOSTON & OKLAHOMA CITY, June 6, 2023 — Wheeler Bio, Inc., an agile, boutique, clinical contract development and manufacturing organization (CDMO) today announced the appointment of Dr. Stewart McNaull as Chief Business Officer (CBO).
Wheeler Bio and Charles River Laboratories Announce Agreement to Build and Operate RightSource℠ Laboratory
RightSource℠is Charles River’s insourced, purpose-built lab offering that provides industry-leading expertise conveniently placed within a Wheeler Bio’s new cGMP drug substance facility. OKLAHOMA CITY, OK., May 31, 2023 — Wheeler Bio, Inc., a contract development and manufacturing organization (CDMO), and Charles River Laboratories International, Inc.
Richter-Helm's Biomanufacturing Facility Expansion Progress: Inauguration of New Office Building
BOVENAU, Germany – Richter-Helm BioLogics has reached a further and important construction milestone during the expansion of its production site in Bovenau. We officially and ceremoniously inaugurated the new office building on May 31, 2023 together with the mayor of Bovenau, Mr. Ambrock, two years after the groundbreaking ceremony. “The new office building offers our employees a modern open-space workplace including an in-house canteen.
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