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Bioanalytical Testing Trends in 2022

An increasing number of clinical trial registrations, more R&D investment, growing demand for biopharma products, a continued focus on safety and quality, and more third-party testers entering the market are key reasons why the US pharmaceutical analytical testing outsourcing market is expected to reach $5.55 billion in the next five years.1  Globally, the market could reach $12.4 billion by 2028.2

Specifically, bioanalytical testing is anticipated to experience the fastest growth over this period.1 In fact, this segment led the global market in 2020 due to the high number of clinical trial registrations.2 Alcami offers comprehensive serv­ices to support biologic drug product development from preclinical/early-phase programs through commercial. Its bioanalytical testing services are designed to support drug substance and drug product development, vali­dation, and routine analysis, including associated raw materials, excipients, components, and finished goods. Typ­ical programs include therapeutic pro­teins, peptides, and nucleic acid products. Capabilities consist of cell-based assays with associated cell cul­ture workflows, ELISA, electrophoresis, amino acid analysis, HPLC/UPLC with various detection modes such as UV/PDA, CAD, ELSD, RI, FLD, and MS.

“Alcami utilizes high resolution MS for intact mass analysis. We perform identity testing of post-translational modifications, glycan analysis, and peptide mapping,” explains Katie Schlipp, Vice President, Laboratory Operations, Alcami. “Additionally, these products are commonly ana­lyzed by ion pairing chromatography, ion-exchange chromatography, and PCR-based approaches.”

Alcami also offers a high-throughput method development for efficient screening of solvents and columns. This platform allows Alcami to select optimal parameters quickly and develop robust and QC-friendly methods in much shorter timeframes, says Ms. Schlipp.

There are some specific key mar­ket trends that Alcami is seeing in the industry. One is the need for microbial in-use or admixture compatibility stud­ies. A microbial in-use study is intended to evaluate the growth of a low level of microorganisms inoculated into the diluted product over the hold time to represent inadvertent contam­ination during rehydration or dilution of the product.

These studies determine if the product will support the growth and/or proliferation of this inadvertent contamination during the holding pe­riod prior to patient administration. “Our team of experts can support the experimental design and execution of in-use studies and provide a final sci­entific report for our client’s filing,” she says.

A second trend is an increase in the need for environmental monitor­ing. “The global health crisis triggered by the COVID-19 pandemic has in­creased the demand for sterilized pharmaceutical formulations and sci­entific advancements in cleanroom technology,” says Ms. Schlipp. “Alcami experts can guide customers through the stringent regulatory framework as­sociated with cleanroom space and provide support specifically tailored to the needs of each cleanroom to en­sure that quality, safety, and efficacy are maintained.”

She adds that a successful envi­ronmental monitoring program be­gins with the appropriate risk assessment, qualification, and certifi­cation activities for the space and util­ities that lay the groundwork for routine testing. To this end, Alcami provides support in personnel plating, sampling performed during client manufacturing activities, and expertise in remediation efforts in case of unfor­tunate events such as failure to HVAC systems.

She says: “Environmental services are holistically enhanced by Alcami’s microbiological services, from micro­bial and fungal identification to disin­fection efficacy and biological indicators testing.”

Beyond these capabilities, Alcami is investing in new capabilities, includ­ing analytical ultracentrifugation, vari­able pathlength UV for A260/A280 determinations, and new Tandem Quadrupole and QTOF instruments as part of a 16,000-square foot reno­vation in its Durham, NC, laboratory to be commissioned early this year.

Along with the significant invest­ments in analytical capabilities and expansions, Alcami recently an­nounced the acquisition of Masy BioServices. “GMP storage is a critical need in the pharma industry,” says Ms. Schlipp. “Masy offers secure and tightly controlled GMP temperature storage from -196°C to 70°C, includ­ing all ICH stability conditions, for var­ious materials including vaccines, biopharmaceuticals, cell banks, tis­sues, compounds, and medical de­vices. In addition, pharma support services through Masy include equip­ment calibration, large-scale valida­tion and qualification projects, SenseAnywhere monitoring system, and equipment sales, and rentals.”

 

Article Details

Drug Development & Delivery
Issue: January/February 2022

References

  1. United States $5.55 Billion Pharmaceutical Analytical Test­ing Outsourcing Market – Size, Share & Trends Forecast to 2027, Research and Markets, Feb. 1, 2021, https://www.globenewswire.com/en/news-release/2021/02/01/2167066/28124/en/United-States-5-55-Billion-Pharmaceutical-Analytical-Testing-Outsourcing-Market-Size-Share-Trends-Forecast-to-2027.html.
  2. Global Pharmaceutical Analytical Testing Outsourcing Market Analysis Report 2021-2028, ResearchAndMarkets.com, Oct. 12, 2021, https://www.businesswire.com/ news/home/20211012006008/en/Global-Pharmaceutical-Analytical-Testing-Outsourcing-Market-Analysis-Report-2021-2028.

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