In pharmaceutical science, several divergent paths typically exhibit clear validity. Decisions often boil down to embracing instead of eschewing risk, to accelerate as the only priority, or to trust a partner rather than emphasize self-reliance. Each molecule, each company or research group possessing that molecule, has an assortment of strengths and weakness to guard against or to leverage. Multiple factors weigh in the balance when deciding how best to move forward, and increasingly the route chosen is to outsource research, development, and manufacturing.

The global contract development and manufacturing organization (CDMO) industry, averaging across several market research firm estimates, is currently valued around $100 billion (1). In part, this growth is shaped through direct regulatory influences suggesting, if not demanding, that a drug have multiple sites of manufacture to spread the risk for supply chain planning. Above regulations, companies also seek to reduce the complexity of their operations internally, and to reallocate internal resources most effectively.

When referring to this article, please cite it as C. Spivey, “Balancing Internal Focus Against External Capabilities,” 

BioPharm International Partnerships for Outsourcing

Articles

Development

Demand for outsourced services of technical R&D activities is increasing.

Balancing Internal Focus Against External Capabilities

It wasn’t long ago that pharmaceutical companies did their own research and development in-house, from discovery through investigational new drug (IND) submission. Today, it’s hard to find pharmaceutical companies of any size, from large global pharmaceutical entities down to the smallest biotech company, that has not outsourced some aspects of their work to a third-party organization, whether that be academic institutions, biotech startups, or contract research organizations (CROs). These relationships are likely to continue to grow exponentially. A new market report released this year estimates that the global biotechnology and pharmaceutical services outsourcing market will surpass $91.4 billion US by 2028 because of a 5.2% compound annual growth rate (CAGR) (1).

Today, roughly two-thirds of R&D is being outsourced, with CROs growing dramatically to fill the gap. How can service providers and clients assure that the relationship will be mutually advantageous? What are some of the best practices to ensure a high-quality product? This article will look at how to ensure contracts are established and signed quickly so that science moves forward, why quality assurance (QA) is integral to meeting regulatory compliance, how compromise and coordination are necessary for any winning partnership, and whether geography is important given the globalization of today’s economy.

 BioPharm International’s Partnerships for Outsourcing eBook.

1. H. Balfour, “Biotech and Pharma Services Outsourcing Market to Be Worth Over $91bn by 2028,

Peter Gaskin, PhD, is the senior director of scientific advisory services for Charles River, an AAPS sustaining partner.

When referring to this article, please cite it as P. Gaskin, "The Essential Ingredient in any Sponsor-CRO Partnership: Trust," 

Outsourcing

To build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.

The Essential Ingredient in any Sponsor-CRO Partnership: Trust

To foster the development of treatments for undertreated and rare conditions, FDA grants orphan drug designation to drugs and biologics that treat, prevent, or diagnose diseases that affect fewer than 200,000 people in the United States or drugs that meet certain cost recovery provisions (1). This designation comes with incentives such as tax credits, user fee exemptions, and market exclusivity. To receive such designation, sponsors must submit requests and present data to support the request.

 asked Judith Jones, FRSC, Director Regulatory Affairs, Global Regulatory Affairs, Catalent, and Matthew Mollan, RPh, PhD, Regional Head of Operations, Early Phase Development North America, Catalent, about the specific ways contract development and manufacturing organizations (CDMOs) can assist sponsors in developing, applying for, and manufacturing orphan drugs.

When referring to this article, please cite it as S. Haigney, “Fostering Orphan Drugs,” 

Quality/Regulations

CDMOs offer expertise and customization options for sponsors of orphan drugs.

Fostering Orphan Drugs

The COVID-19 pandemic highlighted the potential of an array of modalities within the biopharmaceutical industry. In particular, the success of messenger RNA (mRNA)-based COVID-19 vaccines has encouraged biopharmaceutical companies to explore and utilize these technologies for other diseases and look to rapidly expand their capacity and capabilities in response to an upsurge in demand.

At the end of 2019, the combined market capitalization of the five publicly listed companies focusing on mRNA platforms was $15 billion, and as of August 2021, that value of capitalization reached more than $300 billion (1). This significant boost in market valuation reflects the optimism that mRNA technology can deliver much more and go beyond the current prophylactic COVID-19 vaccines.

James Park is executive vice-president and managing director of the Global Sales Center at Samsung Biologics.

When referring to this article, please cite it as J. Park, “Preparing for the Future: Expanding Capacity and Facilitating Multi-modalities,” 

Manufacturing

CDMOs need to consistently demonstrate agility as demand increases for newly developed therapeutic modalities. 

Preparing for the Future: Expanding Capacity and Facilitating Multi-modalities

Actions speak louder than words, and in the highly competitive biopharmaceutical market large acquisitions are often the equivalent of shouting one’s intentions from the rooftops. In this vein, 

 has collected the latest acquisition news from major contract, development, and manufacturing companies (CDMOs) in the hopes of providing insight into possible market movements.

Merck KGaA, “Acquisition of Exelead Completed, Plans to Invest More Than € 500 Million in Technology Scale-Up,” Press Release, Feb. 23, 2022.

Catalent, “Catalent Acquires Facility in Oxfordshire to Expand Biologics Capabilities in the UK and Across Europe,” Press Release, April 6, 2022.

Recipharm, “Recipharm acquires GenIbet to bolster Biologics offering,” Press Release, Feb. 1, 2022.

Recipharm, “Recipharm expands its advanced therapy medicinal products (ATMPs) offering into Virotherapies with the acquisition of Vibalogics,” Press Release, Feb. 18, 2022.

Recipharm, “Recipharm Acquires Arranta Bio, a CDMO Leader in Advanced Therapy Medicinal Products (ATMPs), to Expand Its Niologics Offering in the US,” Press Release, Feb. 18, 2022.

Samsung Biologics, “Samsung Biologics Reaches Agreement with Biogen to Acquire Full Ownership of Samsung Bioepis,” Press Release, Jan. 27, 2022.

FDA, “FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes,” Press Release, July 28, 2021.

FDA, “FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira,” Press Release, Oct. 18, 2021.

FDA, “FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions,” Press Release, Sep. 17, 2021.

ten23 health, “Launch of ten23 health – opening a new chapter in contract pharmaceutical development and manufacturing services,” Press Release, Sep. 1, 2021.

ten23 health, “Swissfillon, a Leader in Sterile Filling of Complex Pharmaceuticals, Joins ten23 health and Enhances the Combined Company’s Integrated Offering to Its Customers,” Press Release, Oct. 25, 2021.

Fujifilm Diosynth Biotechnologies, “Fujifilm Expands its Advanced Therapies CDMO Business with the Acquisition of a Dedicated Cell Therapy Manufacturing Facility from Atara Biotherapeutics, Inc.,” Press Release, Jan. 26, 2022.

Fujifilm Diosynth Biotechnologies, “FUJIFILM Diosynth Biotechnologies Doubles its Existing Laboratory Footprint in North Carolina,” Press Release, Jan. 5, 2022.

Grant Playter is the Assistant Editor at 

When referring to this article, please cite it as G. Playter, "The CDMO Carousel," 

Acquisitions in the CDMO space can give us insight into a company's vision for their future.

The CDMO Carousel

In the modern bio/pharmaceutical industry, countless services are outsourced, including manufacturing, process development, scale-up, regulatory compliance assistance, analytical services, software and cloud services, and much more. But what should companies looking to outsource know prior to selecting vendors and partners? In addition, what should the companies that are outsourcing services be aware of?

 interviewed David Heiger, associate VP, Agilent CrossLab Group; Nandu Deorkar, vice president of R&D production, Avantor; Sébastien Ribault, vice president and head of end-to-end solutions, Life Science business of Merck KGaA, Darmstadt, Germany; Angelo Filosa, PhD, portfolio director, professional and technology services OneSource, PerkinElmer; and Christoph Zehe, research fellow, advanced cell biology, Sartorius Corporate Research, on what outsourcing partners wish you knew.

When referring to this article, please cite it as M. Rivers, “What Outsourcing Partners Wish You Knew,” 

Industry experts share their top outsourcing tips from both the perspective of companies offering outsourcing services as well as for companies looking to outsource. 


What Outsourcing Partners Wish You Knew

The global biopharma market has experienced a remarkable period of evolution and expansion. In that time, parenteral medications have become one of the industry’s most important innovation and growth drivers.

Fueled by a continuing shift toward at-home, self-administered care—an established trend accelerated by the COVID-19 pandemic—the rapid surge in demand for injectable therapies is set to continue in the coming years. Between 2020 and 2027, sales of parenteral medications are projected to expand from 53–57% of global market volume, with most of those gains taken away from oral drugs (1).

Markus Hörburger is product and service manager Secondary Packaging & Device Assembly at Vetter.

When referring to this article, please cite it as M. Hörburger, “Converting Injectable Therapies to Combination Drug-Device Products,” 

The author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.