From screening to development to manufacturing, analytical partners provide invaluable insights.
Traditional pharmaceutical manufacturing has always involved a certain amount of trial and error. Polymorphs and biological molecules are screened as they’re detected. Pilot batches are analyzed as they emerge from the chamber. Cleanrooms and pipelines are adapted as needs change. Packaging is designed according to best guesses about consumer appeal. Lawsuits and competing products are dealt with as they appear.
But a new wave of analytics experts are helping their pharma partners shift their tactics in all these areas from reactive to proactive; from merely mitigating risks to anticipating them beforehand, and addressing them head-on. This paradigm shift is poised to profoundly disrupt every sector of the pharmaceutical industry.
While analytics experts specializing in pharma aren’t always easy to find, companies who seek these experts out and partner with them are already achieving increases in efficiency, gains in margins, and an extraordinary ability to stay several steps ahead of the competition. Here are just some of the critical ways in which analytics are transforming pharma.
Screening analytics streamline the process of identifying and characterizing useful compounds.
Every drug dosage form begins with an active pharmaceutical ingredient (API). That API can take a wide range of forms, from pure crystalline and noncrystalline compounds to multicomponent systems of cocrystals, including hydrates, solvates and salts. But these solid-state compounds can form according to a variety of structures. Variations in structure, known as polymorphs, can significantly impact the API’s stability, solubility, and pharmacokinetics.
To add further complexity to these challenges, polymorphs often take shape unpredictably, leading to surprising variations in a drug’s chemical properties. And because it’s next to impossible to know in advance how many polymorphs exist for a given compound, competitors may create and patent newly discovered polymorphs of known APIs, leaving those APIs’ original discoverers with smaller shares of the drug markets they helped create.
In light of all these concerns, it’s no surprise that pharmaceutical developers often partner with contract manufacturing organizations (CMOs) who have expertise in screening technologies like X-ray Powder Diffraction (XPRD), as well as infrared, Raman, and nuclear magnetic resonance (NMR).
Experts in screening analytics also specialize in using high-throughput techniques to screen hundreds of molecules per day, vastly streamlining the selection of ideal APIs to include in your formulation, while also identifying potentially useful polymorphs and other molecular variations.
Formulation analytics help quantify chemical properties, and identify potential challenges.
Although every dosage form begins with an API, many complete formulations also include excipients such as diluents, surfactants, pH adjusters and bulking agents, which alter the formulation’s chemical and mechanical properties in desirable ways. However, some of these excipients may create unintended impacts on the bioavailability of the API, or even on other excipients.
While the traditional approach to formulation development follows a pattern of hypothesis, trial, error, and improvement, an increasing number of pharma developers are circumventing much of this time-consuming complexity by partnering with analytics experts who can proactively identify impurities, sensitivities, and other potentially challenging traits of a formulation.
By pinpointing these chemical properties before a single batch has been manufactured, developers can avoid making costly investments in test batches whose chemical properties wouldn’t measure up to the target product profile (TPP).
Batch analytics help identify promising variations, and reduce undesirable ones.
Once a formulation fitting the TPP has been developed, the next step is to manufacture a series of pilot batches, and analyze each batch’s adherence to the drug’s intended physical and pharmacological profile. In this early stage, it’s common for some batches to emerge from the pipeline with variations; some of which may be desirable, while the majority will not.
Throughout this pilot batch stage, analytics experts can use statistical methods to rapidly identify promising pilot batches, minimizing time and resources invested in less-viable variations of the drug. Along the way, these analysts can detect any unexpected sensitivities, or other problematic characteristics, before the developer invests a much larger amount of time and resources in clinical-scale manufacturing.
Manufacturing analytics help ensure GMP compliance and reduce downtime.
Scaling up to the manufacturing phase involves adjustments throughout the organization, from increases in staff and equipment to rethinking of the pipeline as a whole. Facilities that manufacture clinical-stage pharmaceuticals will.inevitably come under scrutiny by organizations such as the US Food and Drug Administration (FDA), who are particularly concerned with a facility’s adherence to good manufacturing practices (GMP) guidelines.
The field of pharma manufacturing pipeline analytics is still young, and experts in applying analytics to GMP can be tough to find. But the benefits of an analytical approach to manufacturing will repay the investment many times over. A facility that takes proactive steps to improve its GMP compliance will be much less likely to experience downtime due to regulatory crackdowns.
But avoidance of regulatory restrictions is far from the only benefit of manufacturing analytics. A facility that adopts a data-driven approach to its pipeline will also experience less downtime due to logistical hangups and process overhauls. Taken together, these benefits make a compelling case for the use of analytics in facility management.
Cleanroom analytics help prevent contamination and other safety issues.
Chemical hazards in the pharmaceutical industry carry elevated risks, since active pharmaceutical ingredients (APIs) are specifically designed to target chemical pathways in the human body. For this reason, the US Occupational Safety and Health Administration (OSHA) provides strict guidance for the handling of hazardous pharmaceuticals; particularly highly potent APIs (HPAPIs).
These hazardous compounds must be handled in cleanrooms, where precautions include segregated areas for handling compounds, sterilization of all equipment and protective clothing by autoclave and/or radiation, single-pass heating, ventilation, and air conditioning (HVAC) systems, restricted access airlocks, closed-system glassware, misting showers in degowning chambers, and change-control procedures designed to minimize direct contact with air and other elements that may contain trace amounts of the HPAPI.
The application of analytics to cleanroom design and organization enables staff and facility managers to take proactive, data-driven steps to address potential safety hazards before they ever manifest in the first place. This means employees can enjoy a safer working environment, in a more efficient, cost-effective facility.
Packaging and market analytics enable design of more durable and attractive containers.
No matter how much effort is put into the development of a stable, bioavailable drug product, certain vulnerabilities may only emerge once the drug is packaged, shipped, and stored for extended periods. The pharmaceutical industry abounds with examples of painstakingly engineered drugs that turned out to degrade when they came in contact with trace amounts of a some packing material, or while stored under uncontrolled conditions.
This is precisely where packaging analytics displays its usefulness. By applying statistical methods to the selection and composition of packaging materials, analysts can predict issues before they have a chance to ruin a single batch, and recommend cost-effective replacements for problematic packages.
In the field of market analytics, meanwhile, experts identify specific packaging and labeling variations that will make the drug stand out among competitors on the shelf, and remain imprinted on customers’ memories for the next time they’re in need of pharmaceutical help.
Analytics throughout the pipeline can protect against lawsuits, as well as certain types of competition.
As helpful as all these applications of analytics are, the true value of an expert analytical partner lies in their ability to integrate data from a wide variety of sources, throughout an entire organization, in order to anticipate and mitigate risks that might otherwise remain undetectable until it’s too late.
For example, screening analytics’ ability to detect potentially useful polymorphs can enable developers to patent those crystalline variations, eliminating competitive formulations that might otherwise use those polymorphs. In a similar way, an organization-wide commitment to collecting and organizing internal research data can enable analysts to build a strong case for an intellectual property claim, protecting the organization from costly legal entanglements.
From small molecules to complex biologics, from pilot batches to full-scale manufacturing pipelines, from initial screening to commercial packaging and marketing, analytics provide unparalleled insights into every stage and aspect of pharmaceutical development.
While analysis who specialize in some of these areas may be hard to find, the intelligence they gather enables them to make innovative recommendations, and help pharmaceutical companies get out in front of problems their competitors haven’t even detected yet. For all these reasons, specialized analytics partners are key assets for any forward-thinking pharma firm.
