Consolidation in the contract manufacturing landscape in recent years has resulted in service providers that now have varied scientific, technical, and technology expertise. The ability to provide real-time data analytics is in high demand, and there is a need for innovative flow filtration technologies, factors that seem to be driving some of this consolidation.

ioPharm International’s Partnerships for Outsourcing 

Feliza Mirasol is the science editor for 

When referring to this article, please cite it as F. Mirasol, “CDMO Landscape Seeing Changes as Consolidation Continues," 

BioPharm International Partnerships for Outsourcing

Articles

Manufacturing

The expected growth of the global bio/pharmaceutical market is pushing for the continued evolution of the CDMO arena.

CDMO Landscape Seeing Changes as Consolidation Continues

Since the commercialization of an antisense oligonucleotide and subsequent RNA aptamer therapies in the late 1990s and early 2000s, respectively, a diverse set of RNA-based drugs that tackle wide ranging therapeutic needs have emerged in development. Most recently, two messenger RNA vaccines for COVID-19 have received emergency use approval by global regulatory bodies, representing a milestone success, according to topical commentary.

The successes of such therapies are being reflected in the potential growth of the RNA therapeutics market, which is expected to be strong in the near future with some market analysts estimating its worth at $2612.11 million by 2025. Inevitably, market growth is spurred by an increase in demand, which in turn is giving rise to more opportunities for contract manufacturing organizations to service the sector.

To discuss RNA contract manufacturing services in more detail, 

 spoke with David Ricketts, director of Business Development for Manufacturing Services, and Bernard Sagaert, chief operational officer, both at eTheRNA immunotherapies NV—a company that extended its RNA contract manufacturing services in November 2020 to meet growing demand.

Felicity Thomas is the European editor for 


eBook: Partnerships for Outsourcing, May 2021
May 2021
Pages: 8–10

When referring to this article, please cite it as author, “RNA’s Expanding Horizons,” 

BioPharm International Partnerships for Outsourcing eBook

As the RNA therapeutic market grows, contract manufacturing services for GMP-grade RNA are in demand and expected to continue on an upward trajectory.

RNA’s Expanding Horizons

Nowadays, many biopharmaceutical operations are outsourced, from R&D to regulatory-driven testing services. These outsourcing activities require a network of partners working hand-in-hand, as a global ecosystem, to bring new and critical medicines to patients in need. Biopharmaceutical companies are increasingly outsourcing to contract research organizations (CROs) and contract manufacturing organizations (CMOs) to not only keep pace with market demands, but also enable rapid expansion of development and manufacturing capabilities, source partners for innovative early stage R&D programs, and achieve greater cost efficiency in resource and expertise utilization.

Laurent Lafferrère, PhD, is chief operating officer, and Audrey Brussel*, PhD, audrey.brussel@pathoquest.com, is Viral Safety leader; both are at PathoQuest.

*To whom all correspondence should be addressed.

When referring to this article, please cite it as L. Lafferrère and A. Brussel, “Challenges When Outsourcing Viral Safety Services," 

Analytics

Assessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.

Challenges When Outsourcing Viral Safety Services

The rapid scale up for manufacturing of COVID-19 vaccines pressured vaccine developers, contract manufacturing organizations (CMOs), and regulatory authorities to bring production lines to full operation in a short time frame, while adhering to current good manufacturing practices (CGMPs). Sometimes, however, problem arise.

For example, in April 2021, FDA cited an Emergent BioSolutions’ contract manufacturing facility for multiple violations following an inspection of the vaccine production site (1). FDA instructed Johnson & Johnson to take over operations of its COVID-19 vaccine substance, which was manufactured at the site, and ordered the halt of production of AstraZeneca’s COVID-19 vaccine also produced at the facility.

Limited access to CMO facilities for vaccine and drug developers to conduct supplier inspections and oversight can complicate regulatory approval for a facility and impact the quality of the product produced. BioPharm International asked Steven Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates (RCA), to provide insight on how COVID-19 has impacted the oversight of CMOs.


eBook: Partnerships for Outsourcing, May 2021
May 2021
Pages: 18–22

When referring to this article, please cite it as S. Haigney, “Ensuring Contract Manufacturing Facilities Are Up to Speed,"

 BioPharm International Partnerships for Outsourcing eBook 

Quality/Regulations

The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.

Ensuring Contract Manufacturing Facilities Are Up to Speed

The COVID-19 pandemic prompted pharma companies to explore alternate communication forms, including video conferencing and streaming video to conduct remote inspections and audits. Preparation is key for remote vendor and contract partner audits and should be part of the company’s quality management system.

Mike Kawano is director of Vault Quality at Veeva Systems.

When referring to this article, please cite it as M. Kwano, “Succeeding with Remote Audits," 

Preparation is key for remote vendor and contract partner audits.

Succeeding with Remote Audits

Developments in biologics and personalized medicines are reshaping the clinical trial landscape. According to Grandview Research, the global biologics market is anticipated to reach $398 billion by 2025, with growth supported by faster drug approval processes (1). Simultaneously, the increasing prevalence of cancer and rare diseases is providing the catalyst for investment in the development of targeted therapies. These precision medicines, which are tailor-made to meet unique patient needs, are expected to reach $85 billion over the next five years, representing a substantial 9.9% compound annual growth rate (2).

Natalie Balanvosky is just-in-time manufacturing solutions manager, and Bryan Thompson is production manager, both with Almac Clinical Services.

When referring to this article, please cite it as N. Balanvosky and B. Thompson, “Demystifying Complex Clinical Trial Kit Preparation," 

Operations

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

Demystifying Complex Clinical Trial Kit Prep

Collaboration between contract development and manufacturing organizations (CDMOs) is often necessary to reach certain manufacturing and development goals. The following is a sampling of recent CDMO partnerships in 2021 so far.


eBook: Partnerships for Outsourcing, May 2021
May 2021
Pages: 34–38

When referring to this article, please cite it as L. Lavelle, “CDMO Partnerships Boost Company Capabilities,"

Recent CDMO partnerships include COVID-19 collaborations, manufacturing partnerships, service agreements, and a strategic alliance expansion.
