Securing end-to-end biopharmaceutical testing services has become increasingly challenging for biopharma companies at all stages of development and commercialization — particularly small or emerging organizations. These companies may need to overcome several factors, including a lack of resources to conduct cGMP compliant testing in-house, concerns about contamination at all-in-one facilities, and/or difficulty commanding personalized attention from large CDMO partners.
Additionally, a multitude of different modalities exist within the biopharmaceutical market, including monoclonal antibodies, proteins, cell and gene therapies, antibody drug conjugates, oligonucleotides, and subgroups within those modalities. Thus, while biopharma companies may choose API or drug product manufacturing sites all over the world, it often is advantageous for them to leverage a single laboratory — with aptitude in all those areas — for analytical service testing, regardless of whether the company is hyper focused in one area or has several drugs in the pipeline.
The 360° Approach: Communication, Collaboration, and Technological Innovation
Many biopharmaceuticals, especially in the cellular and viral spaces, involve complex and unique testing challenges. While some larger biopharmas may retain in-house expertise and equipment to execute some testing, the capital expense of buying equipment, maintaining cGMP compliance, and the ongoing cost of keeping experienced testing personnel on staff does not make fiscal sense for most companies. Further, even companies with some in-house capability can suffer setbacks due to inexperience, infrequent usage of the equipment, or a misunderstanding of shifting regulations.
The process of discovering and implementing solutions with a contracted lab partnership benefits from up-front discussions between the provider and the biopharma client, formulating a plan to accomplish the latter’s goals. This collaborative approach informs the creation of tailored solutions designed to overcome development and commercialization hurdles specific to that client Moreover, by not consolidating testing and large-scale manufacturing of the biopharmaceuticals it supports, a contracted lab’s focus can remain 100 percent on clients’ analytical testing needs. This dynamic also ensures impartiality in determining material quality: the lab can be stringent in its testing standards without being tied to production of the material.
For example, Cambrex’s process starts with initial discussions between our business development team and clients, a dialogue to help us understand their needs. As we develop proposals based on those conversations, we maintain continuous contact with the client. Thus, by the time the proposal has taken shape, they have a detailed understanding of its scope, how it addresses their stated needs, and where additional (previously unknown) needs may have been identified.
Weekly or biweekly meetings between our team and clients keep them constantly updated regarding ongoing projects through release and stability testing. These meetings also regularly examine — and help clients to understand — evolving requirements as their project advances through different phases, including in-process testing or environmental monitoring.
Real-time collaboration and communication become even more vital as projects move toward commercialization and agency testing requirements become more stringent. Accordingly, through each product or test service Cambrex provides, the client interacts with the same project manager (PM), who organizes testing even if it spans several Cambrex departments and sites — ensuring the client enjoys the simplicity of a single point of contact throughout the partnership.
This dynamic exemplifies a key aspect of the 360° approach to biopharma testing: prioritizing the human element. Even the finest technology, strategy, location, and instrumentation can fall short if CDMO and client teams are not aligned and communicative. Partnering with a contract lab (versus conducting testing in-house) not only helps to ensure quality by leveraging experienced testing professionals, it frees biopharma companies’ personnel to focus on their own core competencies or other projects.
Integrated Analytical Services Drive Biopharma Testing Success
Cambrex’s broad reach in supporting small molecule analytics, large molecules, and cellular- and viral-based therapeutics positions us well to devise creative solutions to our clients’ problems. This includes, when necessary, applying new bioassays and technologies. For example, a recent client required detection of a specific bioprocessing impurity and we innovated a novel approach to detect and quantify trace levels of that impurity using quantitative nuclear magnetic resonance (NMR).
Consider that our Durham, NC, site’s key technologies include gel permeation chromatography instrumentation coupled to a multi-angle light scattering (GPC-MALS) system, a capillary electrophoresis (CE) system, and a reproducible platform for nanoparticle characterization, which allows us to perform particle size analysis and distribution of viruses. These instruments are bioinert and have enhanced our service offerings. This state-of-the-art instrumentation is supplemented with spaces engineered to ensure segregation for testing of proteins, DNA, mammalian viruses, and bacteriophage viruses.
Meanwhile, our Agawam, MA, facility provides environmental monitoring of facilities, buffer and raw material release testing, and reference standard creation. We also offer clients in-process testing services, providing fit-for-purpose statements of analysis (as opposed to full GMP certificates of analysis) when needed. This input can be informative in optimizing their processes. When optimization requires changes to a client’s manufacturing process — which, in turn, may require supplemental validation studies — we can help clients identify their gaps and suggest options including re-validation, co-validation, or supplemental validation studies. In short, the Cambrex network (comprising 13 facilities globally) offers a tool for every job. The assembled toolbox means top-to-bottom integrated analytical support for clients as they move through different phases of their regulatory submission.
Cambrex also regularly reevaluates and bolsters its quality systems and safety procedures not only to ensure quality of service, but to maintain a high level of agility in managing a variety of projects (e.g., a portion of the Durham site quality systems has been designed specifically for our new Biosafety Level 1 [BSL-1] and Biosafety Level 2 [BSL-2] service offerings). We also have worked to improve processes related to biopharmaceutical workflows, including next-generation sequencing (NGS) polymerase chain reaction (PCR), and soon we will add digital PCR capability.
Combining Capability and a 360° Ethos
Cambrex offers testing for biopharmaceuticals and small molecules — including peptides, vaccines, proteins, oligonucleotides, and viruses. We are adept at navigating the challenges associated with technical development for clients’ chemistry, manufacturing, and control (CMC) packages, as well as able to support ongoing testing and release where the material is manufactured. Thus, even as our clients may change manufacturing partners between early development and commercial production, their analytics needs can reliably be fulfilled in one place.
Whether Cambrex is engaged by pharmaceutical companies directly or quality/life sciences consultants seeking testing-related guidance for their clients, we field projects at all stages of development and manufacture. Depending on the product’s phase of development and the type of pharmaceutical, their testing needs will change, and a 360° approach to testing offers the flexibility to readily adapt to those evolving needs.
Thus, before attempting to cover all testing in-house or spreading testing across laboratories (i.e., one lab for drug substance, another for drug product), consider engaging a boutique CDMO offering the ability to customize its testing services to the unique challenges of your pharmaceutical. To learn more, visit www.cambrex.com.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysts. Continuous flow, controlled substances, solid-state science, material characterization, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.