PTM by MRM: Introducing New Methods to Solve Old Problems

PTM by MRM: A More Efficient Way to Find What You're Looking For

In biotherapeutic development, post-translational modifications (PTMs) can be as elusive as the proverbial needle in a haystack. Traditional methods for identifying and quantifying PTMs involve a painstaking, linear process of individual assays performed one after the other. They require multiple sample preparations and precious time, and findings are often found insufficient by regulators. ABC Laboratories is pleased to introduce a better way.

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Biosimilars: They Look the Same... But One is a Real Stinker.

Biosimilars Sometimes Behave Differently. The Key is Knowing When it Matters.

Biosimilars by nature look much like their comparator products, but they sometimes behave quite differently. That's because the two products often originate from different cell lines or expression systems. And no matter how hard you strive for parity in the way they're cultured, minor differences in manufacturing can lead to sticky variations in primary amino acid sequence, glycosylation chemical modifications and protein folding issues. The FDA understands biosimilar products sometimes behave differently than their name-brand counterparts. But, they do expect you to understand why those differences occur, and to demonstrate that they have no clinical significance. That's where ABC Laboratories comes in.

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Agrochemical Product Development: Taking Your Product to New Markets?

Get Post-Registration Support from the Product Development Experts at ABC

These days, it takes roughly 10 years and a development budget with eight zeros to successfully register a new crop protection products. But being first to market is just the beginning. Whether you expand into new territories, seek label expansions or require ongoing environmental monitoring, a trusted development partner is just as important post-registration as it is prior to initial regulatory approval.

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Environmental Assessments: Don't Let Your Environmental Package Be a Regulatory Sticking Point

Seamless E/A Solutions from the Drug Development Experts at ABC

A quality Environmental Assessment (EA) package is a critical component of many new drug product submissions. Not having the right data—or not starting EA investigations soon enough—is an often-underestimated development risk. In fact, these common missteps can lead to lengthy environmental fate or ecotoxicity studies that will delay a drug's approval by up to two years. ABC helps develop drugs and evaluates their environmental impacts. Click here for more.

Cytotoxic Drug Development: Choose Your Partner Well

Choose Your Partner Well - Ask ABC

Although regulatory requirements are fundamentally the same for all investigational drugs, working with cytotoxic materials presents unique challenges. Heightened safety procedures and encumbering personal protective equipment can be a drag on timelines—or worse, lead to procedural or analytical errors that compromise data integrity. It's critical to choose a CRO with cytotoxic expertise, yet the field of competent outsourcing partners is small.

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CGMP Radiosynthesis: Will Your CRO Be There When It Counts?

Better Insight, Better Outcomes

Expert 14C radiolabeling for human clinical programs requires extensive training and experience. Having supported radiolabeled studies for more than 30 years, ABC Laboratories was one of the first to produce 14C-labeled API and formulate CTMs under CGMP requirements. Our experienced radiosynthethic chemists have worked with many drug candidates so we can help guide you through the detailed CGMP process. We work in tandem with your chemistry, regulatory, and QA personnel to ensure that a high-quality API or drug product CTM, that meets your specifications, is delivered to the clinic on time. Click here for more.

Extractables & Leachables: Feeling Spooked by E/L Risk?

Let ABC Help Reduce the Risk of E/L Surprises.

When late in development, few unknowns are as worrisome as potential impurities from your packaging or delivery device. That said, it is well understood that container-closure systems can interact with even the most stable formulation. By applying Quality by Design (QbD) principles to your extractables and leachables program, the experts at ABC Laboratories will help reduce the risk of surprises and keep your NDA filing on track. Our approach combines a solid understanding of compound chemistry, careful analysis of potential E/L risks and well-thought-out study design to address regulatory data requirements in an efficient and cost-effective manner. Click here for more.