Behind the Headlines Episode 27

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

Artificial intelligence, machine learning, and novel instruments are helping drug developers.

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

J.P. Morgan Report Lists Biologics, Obesity, China

Top Trends Reshaping Pharma R&D

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The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced on Feb. 15, 2024 that they have launched two public electronic catalogues for real-word data (RWD). The RWD catalogues will help regulators, researchers, and pharmaceutical companies identify suitable data sources for research and assessment of study protocols and results.

Created to promote transparency, encourage good practices, and build trust in RWD, the catalogues build on former databases developed by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The RWD sources catalogue replaces the ENCePP Resources Database. The RWD studies catalogue replaces the European Union electronic register of post-authorization studies. The ENCePP website has been renewed. Data sources, centers, and networks have migrated to the new catalogues; however, some content will remain on the renewed ENCePP website.

Improvements over the previous databases have been included in the new catalogues. An agreed set of metadata have been used to describe and connect data sources to studies, based on a list of metadata published by the HMA-EMA Big Data Steering group in May 2022. Functionalities have been implemented such as a wider set of metadata, enhanced view, and export and data submissions.

“The publication of the RWD catalogues brings the European medicines regulatory network closer to more data-driven regulation. Improving discoverability of data is one of the priorities set in the HMA-EMA joint Big Data Task Force final report (phase two), reflected in the European medicines agencies network strategy to 2025 and implemented through the joint HMA-EMA Big Data Steering Group workplan. Ultimately, these developments will help European patients receive better medicines faster and promote safe and effective use of the medicines on the market,” EMA stated in a press release.

about the catalogues will be hosted by EMA on March 4, 2024. 

Articles

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

EMA and HMA Launch Real-Word Data Catalogues

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

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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.

Pharmaceutical Outsourcing Present and Future

Pharmaceutical Technology/Pharmaceutical Technology Europe Outsourcing Innovation

Chris Spivey is the editorial director of 

 eBook
Issue 2
February 2024
Pages: 31-32

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

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

Andrea Allmendinger is chief science officer at ten23 health.

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

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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.

Managing the Complexity of Modern Sterile Product Developments

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.

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

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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.

Navigating the Preclinical CRO Outsourcing Process

Pharmaceutical Technology/Pharmaceutical Technology Europe Outsourcing Innovation eBook February 2024

 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.

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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

Feliza Mirasol is the science editor for 

BioVaxys Technology announced on Feb. 12, 2024 that has acquired the entire portfolio of discovery, preclinical, and clinical development-stage assets from IMV Inc., Immunovaccine Technologies, and IMV USA. These assets were being developed in the oncology, infectious disease, antigen desensitization, and other immunological fields and were based on IMV’s DPX immune educating platform technology.

As part of the transaction, BioVaxys also acquired the extensive technology portfolio of these assets from HIMV, LLC, an acquisition division formed by Horizon Technology Finance and IMV’s other secured creditors. HIMV was formed for the purpose of acquiring IMV’s intellectual property through a secured party credit bid. The transaction is anticipated to close by Feb. 22, 2024.

Under the deal, BioVaxys will pay $750,000 upfront in cash. It will also make various clinical development and regulatory milestone payments and will pay a 15% share in license revenues as well as a 6% gross sales royalty on product sales. BioVaxys will also pay in shares of its common stock, valued at an aggregate of $250,000.

Through the acquisition, BioVaxys gains maveropepimut-S (MVP-S), a DPX-formulated cancer vaccine designed to deliver antigenic peptides from survivin, a cancer antigen commonly overexpressed in advanced cancers. MVP-S also delivers an innate immune activator and a universal CD4 T-cell helper peptide. MVP-S was recently in Phase IIb clinical trials for advanced relapsed-refractory diffuse large b cell lymphoma and platinum-resistant ovarian cancer. It is also being clinically evaluated in bladder and breast cancer.

The DPX antigen delivery platform is designed to stimulate a specific, coordinated, and persistent anti-tumor immune response and can package a wide range of bioactive molecules in a single formulation, such as multiple nucleic acids/messenger RNA (mRNA), proteins, peptides, virus-like particles, innate immune activators, and small molecules. Thus packaged, these molecules can then be “fed” to dendritic cells and antigen presenting cells to stimulate a specific immune response.

“The DPX platform and addition of maveropepimut-S to our pre-existing clinical pipeline immediately positions BioVaxys as a major player in ovarian cancer and expands our pipeline to include advanced relapsed-refractory diffuse large B cell lymphoma (DLBCL), bladder, and breast cancer,” said Kenneth Kovan, president and chief operating officer, BioVaxys, in a company press release.“We see tremendous commercial potential with the DPX platform, which was a major driver of the transaction. The range of antigens that can be packaged and the cargo capacity of DPX present the opportunity for BioVaxys to monetize multiple development partnerships such as in the multi-valent and mRNA vaccine fields, expand our own immunotherapeutric pipeline, and establish what we believe will be an almost perpetual string of new BioVaxys IP derived from novel DPX formulations. We envision DPX enabling new immunotherapeutics not just from BioVaxys, but from a number of other companies via business development partnerships.”

BioVaxys has acquired the full portfolio of discovery, preclinical, and clinical development-stage assets of the former IMV.

BioVaxys Acquires Full Portfolio of Former IMV

Iain McGhee is vice president of Quality at Ascend.

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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.

Bio/Pharma Outsourcing Innovation February 2024 eBook

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. 

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

Ensuring Quality in Contracted Support

Ania Szymanska is site head of Quality at Scorpius Biomanufacturing.

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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?

How to Evaluate a 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.

 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? 

Nelson Labs announced on Feb. 14, 2024 that its facility in Itasca, Ill., is being established as a Pharmaceutical Center of Excellence for parenteral and ophthalmic drug product manufacturers. The facility will feature more than 30,000 square feet of space and include instrumentation for full chemistry, manufacturing, and controls (CMC) support.

The laboratory is compliant with current good manufacturing practices and includes a SKAN isolator suite for performing testing for sterility assurance. The suite will add to the lab’s existing sterility assurance capabilities. The lab will also provide support for drug substances, drug products, raw materials, and primary container closure release and stability studies, including high-performance liquid chromatography (HPLC), ultra-high performance liquid chromatography, ion chromatography, LC-mass spectrometry detector (MSD); spectroscopic, including UV-Vis, Fourier transform infrared spectroscopy, and atomic absorption; spectrometric, including Inductively coupled plasma mass spectrometry.

“The development of a Pharmaceutical Center of Excellence at our Itasca laboratory reflects our commitment to providing comprehensive CMC support services for POPD,” said Aryo Nikopour, vice president, Global Segment Leader, Pharma, Nelson Labs, in a press release. “Nelson Labs has been a global leader in laboratory testing for over 35 years, known for its scientific excellence and commitment to quality. We are excited to enter this next stage of world-class testing for pharmaceutical and biopharmaceutical products.”

Nelson Labs provides microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. The company as more than 3000 customers and facilities in the United States, Mexico, Asia, and Europe. Services include more than 900 laboratory tests and regulatory consulting.

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

Nelson Labs Creates Center of Excellence for Parenteral and Ophthalmic Drug Manufacturing

Samsung Biologics announced on Feb. 7, 2024 that it has signed a partnership agreement with LegoChem Biosciences, a biotech company focused on antibody-drug conjugate (ADC) programs, to develop and manufacture an antibody for an ADC candidate.

Under the deal, Samsung Biologics will provide antibody development and drug substance manufacturing services for LegoChem Biosciences’ ADC program for treating solid tumors. LegoChem Biosciences intends to submit an investigational new drug application to FDA in the first half of 2025. According to a company press release, non-clinical data has shown promising efficacy results.

Samsung Biologics is on track to adding ADCs to its pipeline. The company expects to have a new standalone, dedicated ADC facility—currently being constructed—to be operational within 2024.

“Collaboration between Samsung Biologics and LegoChem Biosciences will enable us to deliver on our common goal to develop and manufacture efficient and safe therapeutics for patients,” said John Rim, CEO and president of Samsung Biologics, in the press release. “We look forward to working with LegoChem Biosciences to support their pipeline of innovative ADC candidates and secure new opportunities in the fast-growing ADC field.”

“LegoChem Biosciences had previously supplied antibodies for ADC through only overseas companies, but we expect that we will be able to secure a stable domestic supply chain through this contract,” said Yong-Zu Kim, CEO and president of LegoChem Biosciences, in the release.

Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.

Featured Content

Behind the Headlines Episode 27

Ask the Expert

Drug Digest September 2025

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

Top Trends Reshaping Pharma R&D