With the bio/pharmaceutical industry facing patent expirations in the near-term for key drugs, bio/pharma companies are facing the pressure of staying competitive in a bio/pharmaceutical landscape where the therapies are growing increasingly complex amid a major shift toward personalized medicines. 

® spoke with Informa Markets about the critical role outsourcing plays in today’s competitive environment as well as into the future.

Chris Spivey is the editorial director of 

Pharmaceutical Technology/Pharmaceutical Technology Europe Outsourcing Innovation

 eBook
Issue 2
February 2024
Pages: 31-32

When referring to this article, please cite it as Spivey, C. Pharmaceutical Outsourcing Present and Future. 

Articles

Contract service providers must step up their game to stay competitive in increasingly complex bio/pharma market. 

Pharmaceutical Outsourcing Present and Future

In the dynamic landscape of pharmaceutical development, the management of modern sterile product developments has become an increasingly complex task, attributed to the evolving diversity of APIs. The landscape now encompasses a wide range of pharmaceutical entities, ranging from traditional small molecules to the forefront of biotechnological advancements including biologics (e.g., proteins, fusion proteins, bispecific antibodies, antibody-drug conjugates peptides, and nucleic acid-based therapeutics including oligonucleotides, RNA and DNA therapeutics, viral vectors, cell therapy, and more). Most of these later APIs are formulated as parenteral preparations, amplifying the unique multifaceted challenges associated in terms of formulation, manufacturing, administration, and regulatory considerations.

Andrea Allmendinger is chief science officer at ten23 health.
Hanns-Christian Mahler is chief executive officer at ten23 health.

When referring to this article, please cite it as Allmendinger, A; Mahler, H. Managing the Complexity of Modern Sterile Product Developments. 

Managing the intricacies of sterile product development is imperative for successful and compliant outcomes.

Managing the Complexity of Modern Sterile Product Developments

To reduce costs and streamline their internal processes, bio/pharmaceutical and biotech companies are increasingly outsourcing many of their internal operations related to the development of their therapeutic compounds, including preclinical testing. That said, contract research organizations (CROs) are playing a more important role in providing critical testing services required for internal validation purposes and submission to regulatory agencies. Navigating the preclinical testing process can be a somewhat confusing, if not difficult, task including identifying the proper partner for conducting the necessary studies to help advance a promising lead compound from the discovery phase to the initiation of investigational new drug (IND) process. This article will serve as a useful guide, including why/when to outsource preclinical testing, the advantages and disadvantages of outsourcing this testing, and how to effectively choose a partner to conduct this testing.

Daniel Radiloff, PhD, is director of Business Development, Pacific BioLabs.

 eBook
Issue 2
February 2024
Pages: 10-14

When referring to this article, please cite it as Radiloff, D. Navigating the Preclinical CRO Outsourcing Process. 

The need for preclinical testing expertise is growing as molecular complexity increases.

Navigating the Preclinical CRO Outsourcing Process

Affinity ligands play an exciting role in the ever-growing sphere of downstream processing. In speaking with Pharmaceutical Technology®, Phillip Elliott, PhD, associate director of Process Development, BioCina; Jan Bekker, PhD, director, Business Development, Commercial and Technical Operations, BioCina; and Parviz Shamlou, PhD, senior vice-president of Science & Technology, Abzena illuminate the newest innovations with affinity ligands and provide a deeper understanding of the role affinity ligands play in the future of downstream processing.

 eBook
Issue 2
February 2024
Pages: 16-21

When referring to this article, please cite it as Husni, D. A Closer Look at Affinity Ligands. 

A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.

A Closer Look at Affinity Ligands

Working with a contract development and manufacturing organization (CDMO) is a great way for smaller or diversified biotech companies, and even Big Pharma, to expand operations or modalities to reach the patients more efficiently. Outsourcing process development and manufacturing requires a lesser upfront investment with faster timelines while allowing teams at advanced therapy developers to focus on innovation. However, this relationship can deeply impact the quality and efficacy of a product. This article explores the balancing act of ensuring regulatory compliance via internal procedures at a CDMO and what to consider when starting
this relationship.

Iain McGhee is vice president of Quality at Ascend.

Pharmaceutical Technology: Bio/Pharma Outsourcing Innovation

 eBook
February 2024
Issue 2
Pages: 26-30

When referring to this article, please cite it as McGhee, I. Ensuring Quality in Contracted Support. 

Quality

This article looks at the relationship between a CDMO quality organization and the client.

Ensuring Quality in Contracted Support

Drug development companies (sponsors) may assume a commitment to quality is inherent in the operations of every contract development and manufacturing organization (CDMO), simply because product quality is essential for ensuring patient safety. Certainly, every CDMO professes its commitment to quality. So, in evaluating potential partners to manufacture a drug or biologic, how can one accurately assess the CDMO’s commitment to quality?

The answer involves conducting a thorough on-site quality audit, asking the right questions, and requesting detailed information. The answers, data, and documents provided will reveal—by what they contain and what they omit—whether or not the CDMO has a strong quality management system and quality culture.

Bio/Pharma Outsourcing Innovation February 2024 eBook

Ania Szymanska is site head of Quality at Scorpius Biomanufacturing.

 eBook
February 2024
Issue 2
Pages: 22-25

When referring to this article, please cite it as Szymanska, A. How to Evaluate a CDMO’s Commitment to Quality. 

What do you need to ask during the vetting and selection process to ensure your clinical or commercial program won’t be derailed by a quality-related problem? 

Bio/Pharma Outsourcing Innovation, February 2024 eBook

Pharmaceutical Outsourcing Present and Future

Managing the Complexity of Modern Sterile Product Developments

Navigating the Preclinical CRO Outsourcing Process

A Closer Look at Affinity Ligands

Ensuring Quality in Contracted Support

How to Evaluate a CDMO’s Commitment to Quality