Leading analytical lab service providers are increasingly diversifying testing strategies leveraging advanced technologies to enhance efficiency and speed in an era marked by unprecedented therapeutic breakthroughs.

As fast-emerging therapeutic modalities like cellular and molecular medicines call for new analytical methods, the introduction of cutting-edge know-how stretches the boundaries of current pharmacokinetic and immunogenicity assessments, say experts.

And contract development and manufacturing organizations (CDMOs), contract research organizations (CROs), and other analytical lab service providers are aggressively ramping up their service portfolios by combining sophisticated equipment and wide-ranging expertise as changing regulations re-emphasize the need for strong analytical science capabilities.

“SK pharmteco’s analytical capabilities are purpose-built to deliver all capabilities within one campus to support process development and manufacturing operations,” says Dana Cipriano, global head of analytical services, SK pharmteco, an integrated CDMO offering services across cell and gene therapy (CGT), small molecule, and analytical services for drug substances and products.

Headquartered in Sacramento, CA, SK pharmteco has analytical services globally, with a focus on small molecules in Ireland and the U.S. 

According to Cipriano, the CDMO’s analytical team has extensive experience in establishing and optimizing complex methods for highly potent active pharmaceutical ingredients (APIs), with comprehensive qualification and validation capabilities for clinical and commercial products.

Besides, SK pharmteco positions itself as a valuable partner for clients developing innovative drug delivery systems with deep expertise and advanced equipment such as X-ray powder diffraction (XRPD), to help determine the physical form of a solid material, and nuclear magnetic resonance (NMR) spectroscopy, a technique crucial for characterizing complex materials,

Additionally, SK pharmteco, a subsidiary of SK Inc, a South Korean conglomerate, is at the forefront of nitrosamine impurity detection, including small molecule nitrosamines such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), as well as challenging complex molecules for nitrosamine drug substance related impurities (NDSRIs). With new regulations emerging in this area, the CDMO’s expertise ensures clients have access to the latest methods.

“By combining this versatility, advanced equipment, deep expertise, and focus on emerging regulations, along with our commitment to transparency, SK pharmteco Analytical Services offers a unique and comprehensive solution for pharmaceutical and biopharmaceutical companies,” Cipriano contends.

Bioassay support: An industry-wide need?

Biopharmaceuticals are expected to witness the fastest growth in the pharmaceutical analytical testing outsourcing market as the drugs belonging to this category require a high level of testing for the validation of efficacy and safety, reports say.

Even as new drug modalities continue to accelerate beyond therapeutic proteins, the demand is growing for assay development in both traditional biologics and advanced modalities, such as antibody-drug conjugates (ADCs), CGTs, and mRNA vaccines.

“With biologics, we see an industry-wide need for reliable bioassay support to derisk the potency assays, with more and more new testing platforms being available,” says Katie Schlipp, president, lab operations, Alcami.

North Carolina-based Alcami offers analytical development services to support a great variety of therapeutic modalities ranging from small molecules to biologics and CGTs. The CDMO performs method establishment from development to validation and quality control (QC) testing. The availability of multiple labs within the organization lends Alcami the flexibility and agility in supporting its clients’ needs when it comes to end-to-end analytical support for most of the drugs: from sterility and safety testing to bioseparation and bioassays characterization and potency assessment. 

Alcami also possesses an internal equipment validation and IT team. It enables the CDMO to quickly onboard any new analytical testing platform that its clients may need, explains Elena Dukhovlinova, principal scientist, bioassays, Alcami. “Currently we have a variety of equipment that supports small and large molecule characterization and testing including flow cytometry, cell plate imaging, biolayer interferometry (BLI), and analytical ultracentrifugation (AUC) in addition to core capabilities like ultra-performance liquid chromatography (UPLC), mass spectrometry, and capillary electrophoresis.” 

In March, Alcami Corporation announced a new strategic partnership with Tanvex CDMO, a biologics developer offering pre-clinical to commercial biologic CDMO services. Alcami and Tanvex can now offer clients a complete solution from bulk drug substance production through to finished drug product, pairing Alcami’s expertise in liquid and lyophilization sterile filling, packaging, and labeling with Tanvex’s high-throughput bulk drug substance development and manufacturing services.

Armed with over four decades of experience, Alcami provides stand-alone analytical development services and the CDMO’s paperless workflow and robust quality systems allow a seamless integration of lab-generated data into the client’s regulatory submission package all over the world.  

On the demand side, Cipriano of SK pharmteco says that for CGTs and other advanced therapies, the demand still centers around the development and phase-appropriate qualification of cell-based functional potency assays.

The regulatory agencies expect to have these methods developed earlier, with a progressive approach to advancing these methods as the product moves through clinical trials.
At the same time, rapid analytical methods that can characterize product and process impurities more robustly are still at the forefront.

SK pharmteco has expanded capabilities to support CGT contract testing clients, allowing for full analytical programs to be developed, qualified, and validated for product release, characterization, and stability programs.

Methods such as next-generation sequencing, rapid safety testing through molecular-based assays and real-time analytics are being explored and gaining regulatory acceptance. 

For newer modalities such as ADCs, oligonucleotides, and gene-edited products, analytical methods and capabilities to support development, product characterization, release, and stability are needed. Capabilities for structural confirmation, physicochemical testing, and potency are required and need complex equipment and staff with the expertise to execute as these modalities evolve. 

These services may not be “off the shelf,” Cipriano notes, and most are product-specific requiring the capacity to establish these methods at the onset of a program for a customer.  Having the right partner is critical to meeting these demands, establishing client platform programs, finding ways to be efficient, and scaling and utilizing capacity appropriately.

The integration of all SK pharmteco analytical and bioanalytical services, she adds, has allowed for additional services such as material science and raw material testing, extractable and leachable programs, and full analytical development to meet the needs of products in clinical through commercial development.

Clinical trial labs: collaborative and interconnected

The rising number of clinical trials is one of the key drivers of the global bioanalytical testing services market which is forecast to reach $6 billion by 2027, growing at a CAGR of 15.6% from $2.6 billion in 2022, according to an estimate by Markets & Markets, a market research firm.

Leading clinical lab service providers are offering a wide range of solutions and strategies to cater to the ever-changing demands of today’s complex clinical studies.

Additionally, the rise of complex CGTs is expanding the scope of specialty testing requirements in clinical studies, necessitating laboratories to broaden their capabilities.

“Our operations model with a menu of over 5000 tests, manages both routine and specialty testing through a single point of accountability,” says Joe Marino, vice president, scientific services at LabConnect, a global lab services provider for clinical trials.

This unique approach, adds Marino, ensures seamless coordination and standardized processes across diverse geographic regions. In addition, LabConnect’s integrated database consolidates all lab results, ensuring compliance with Clinical Data Interchange Standards Consortium (CDISC)/Study Data Tabulation Model (SDTM) standards and submission readiness, which simplifies regulatory filings for the clients.

With a global footprint spanning 93 countries and an industry-leading menu offered by the network of world-class laboratories, LabConnect makes sure that it “can support trials with end-to-end clinical laboratory services no matter how complex the study” is.

LabConnect’s central lab services cover lab kit production, sample management, lab samples and data management.

In April, LabConnect acquired A4P Consulting Ltd. (A4P), a UK-based scientific consultancy company, specializing in bioanalytical and biosample project management, biomarker strategy and logistics solutions in support of pre-clinical and clinical trials.

“This is about staying ahead,” comments Marino, “addressing the rapidly evolving technologies used in clinical testing and ensuring sample integrity on a global scale.”

To ensure sample processing stability, which can sometimes be a challenge limiting the analytical geographic scope, LabConnect has developed the Global Sample Processing Network (GSPN). This innovative solution broadens global access and provides a comprehensive and highly qualified network of laboratories to quickly receive samples from site to processing lab, ensuring better recoveries, consistent quality, and improved cell viability, adds Marino.

Further, study demands are becoming complex and ever-changing. Drug makers sometimes need to quickly support and extend their clinical trial teams with additional scientific and technical expertise.

As testing models become increasingly complex, access to broad technical expertise can be a hurdle for the industry, points out Marino. “That is where our Functional Service Provider (FSP) solutions team comes in,” he says. “This team allows our customers to access staff with scientific acumen for analytical tasks such as, assay validation, data monitoring, test plan development, and regulatory submissions, augmenting their clinical teams. This strategic approach accelerates the drug development process and enhances overall efficiency for our clients.”

In this unique FSP model, LabConnect’s global team of technical and scientific experts support their clients, serving as an extension of their clinical team, quickly coordinating all laboratory-related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions to meet the evolving study demands of traditional to increasingly complex clinical trials.

FSP solutions are offered across scientific project management, biospecimen management and vendor management.

With over 1600 clinical trials across multiple therapeutic areas worldwide, LabConnect has a wide range of therapeutic areas including CGTs, immuno-oncology and vaccines.

It is all about collaborative and interconnected labs that facilitate seamless data sharing and interdisciplinary partnering to foster a dynamic ecosystem for the pharmaceutical and biopharma industries.

A compelling strategy

Industry reports show that analytical and testing are the most outsourced services in the pharmaceutical sector and bioanalytical testing plays a major role in all phases of pharmaceutical and biopharmaceutical development.

Unlike earlier, where pharma and biopharma companies used to outsource only late-phase drug development and routine processes, in recent years they are increasingly outsourcing testing services much earlier in the development cycle.

The key objective of pharmaceutical companies choosing to outsource is to gain access to innovative technologies to accelerate product development and instrumentation.

Advancements in technology are also driving the trend towards outsourcing of analytical testing, notes Marino of LabConnect. “Innovations such as increased sensitivity, new developments in multiplexing, and improved stability are changing the field of analytical testing,” he says. “These advancements require scientific expertise that clinical laboratory service providers like LabConnect leverage to create efficiencies and cost savings for sponsors who may not have the resources to invest in analytical expertise internally.”

It may not be feasible for pharmaceutical companies to purchase and operate specialized equipment themselves for a limited number of programs. Contract labs support hundreds of programs, making significant investments worthwhile and enabling them to hire and retain qualified, experienced staff for specialized testing. Examples of this include inductively coupled plasma-mass spectrometry (ICP–MS) and inductively coupled plasma-optical emission spectrometry (ICP–OES), which are used to detect elemental impurities.

Virtual companies that do not have any internal analytical capabilities usually call on one or more CROs to do all of their analytical testing.

Another trend observed is that clients are willing to outsource end-to-end analytical support to a CDMO that is not the primary manufacturer of their drug substance or drug product, says Katie Schlipp of Alcami. “The main driver for this decision is usually a method development and testing bottleneck at the manufacturing site,” she says.

The accessibility of specialized analytical testing service providers with key capabilities to deliver optimal results rapidly is yet another factor that has led to growing consideration among pharmaceutical businesses to outsource testing services to third-party providers.

“With pharma and biopharma companies under ever-increasing pressure to streamline operations, optimize costs, and accelerate timelines, analytical lab outsourcing services present a compelling strategy,” observes Cipriano of SK pharmteco.

By offering more expertise and instrumentation than many in-house labs can maintain, customers can tap into cutting-edge technologies and specialized capabilities for specific projects, ensuring they have the right tools for the job.

Outsourcing can also eliminate the need for significant capital expenditures on equipment and infrastructure while also providing economies of scale, potentially offering lower per-test costs.

Additionally, Cipriano maintains that in-house labs can struggle to adapt to fluctuating workloads. Outsourcing allows the possibility to seamlessly scale analytical capabilities up or down based on project needs, ensuring the necessary capacity is available without underutilizing resources.

Just as there are no two molecules alike, there are no partner needs that are the same.

A challenge, however, is the need to adapt to global regulatory requirements and changing analytical performance expectations, says Marino. Providers must have the expertise to drive the necessary changes without impacting timelines.

The main challenge and the biggest reward, notes Elliot Franco, vice president, lab operations, RTP, Alcami, is to evolve into a modality-agnostic service provider, as more clients become “generalists” and develop a large variety of therapeutic molecules. “That’s the path Alcami has chosen, and we are thrilled to grow and evolve with and for our clients,” Franco beams. 

---

Soman Harachand is a pharmaceutical journalist based in Mumbai and a regular contributor to Contract Pharma. He can be reached at harachand@gmail.com.