GMP Manufacture of IMP

At our two dedicated GMP facilities, we specialise in small-scale IMP and placebo manufacturing of early phase clinical studies from First in Human (FIH) trials to phase II.

With an emphasis on phase appropriate GMP manufacturing, we can provide just enough clinical trial materials to allow you to conduct your clinical studies quickly, without waste and unnecessary expense.

We offer a rapid and cost-effective alternative to conventional CDMOs, providing “just in time” manufacturing services which enable small batches of drug product to be made throughout the duration of a clinical trial without the need for extensive stability programmes.

Clinical Manufacturing Services

Our GMP manufacturing services can provide non-sterile dosage forms including:

· Immediate, sustained and modified release tablets

· Dual API release (IR/SR) tablets

· Solid fill capsules

· Powder blends

· Dry granulation

· Radiolabelled products

· Placebo manufacture

  • Matched placebo tablets
  • Over-encapsulation of tablets/capsules

· Simple IMPs

  • Neat-fill API capsules

All products are batch released by our in house UK qualified QPs who are actively involved throughout the product life cycle.

GMP Support Services

Pharmaceutical packaging and labelling- Including bottles, foil sachets and blisters,

Blinded packaging

Preparation of IMPD for regulatory submissions

Analytical Testing

At BDD, phase appropriate analytical methods are developed and validated for each stage of your clinical development journey from formulation optimisation to QC release testing including:

· Appearance

· Assay and Related Substances (UV, HPLC)

· Blend Homogeneity / Content Uniformity

· Dissolution

· Disintegration

· Tablet Hardness / Friability

· Water Content (Karl Fischer)

Why BDD

Experienced Team

BDD has over 25 years of success conducting early-phase confirmatory clinical trials.

Founded and Led by Science

Established in 1999 by scientists, BDD has consistently placed great science at the forefront of everything we do.

Proven Reliability and Track Record

BDD has a superb track record of reliability, supporting clients from formulation through to the clinic, with hundreds of satisfied partners.

Faster

BDD’s Lean Clinical Development™ approach significantly accelerates traditional development pathways.

Industry-Leading Recruitment

For decades, BDD has built a robust and effective database of volunteers and patients, achieving an industry-leading 80.2% screening-to-enrolment rate. With BDD, your study starts on time.