Services

Company Expertise & Service Offerings

Company Offering

Highly experienced Pharma DP Technical Services leader delivering:

  • A structured framework of diagnostics & solutions to realise significant value return for a manufacturing operation’s budget tailored to your site’s environment & standards.
  • Effective & efficient technical leadership in a wide range of areas from process & product changes, quality investigations, to manufacturing network strategy development & Tech Transfer. Leveraging 15 years experience working directly with CMOs.
Primary Service

Optimisation of Manufacturing Process performance

An E2E structured framework to diagnose & optimise drug product manufacturing & packaging performance, realising significant value for your business. An approach which goes beyond just process capability.

Additional Services

  • Quality investigations leadership; CAPA development & implementation strategies

  • Technical leadership in Business Case development for major product or process changes

  • Supply Network strategy development: Drug Product manufacturing source changes; Tech Transfer strategy, including technical due diligence & most cost-effective Tech Transfer plan to deliver equivalent or improved process performance & product quality.

  • Specialised Tech Services experience in the Contract Manufacturing Drug Product environment.

  • Tech Services Staff Training & Mentorship e.g. technical change management (materials & process), Process Development & optimisation, Drug Product Tech Transfer.

Case Studies

Sterile injectable

Case Study 1

61%true E2E yield, vs. 96.8% reported
€450kannual manufacturing cost reduction
ca. 25%operating margin improvement

Challenge

A company has been manufacturing a high volume sterile injectable product for many years. The active ingredient is a commodity material and relatively inexpensive compared even with generic product APIs. It provides a good revenue stream to the company and its supply is critical to patients who need it.

Approach

As part of a program to identify waste across the manufacturing site, a KPI assessment of the product’s manufacturing process was conducted. It was quickly identified that Process Yield was readily available only on the final 2 steps of the process and was at 96.8%. However, taking an E2E cumulative view the process capability analysis revealed that the true yield was just 61%. Further assessment revealed that part batches were being lost at the front end of the process due to various factors and the loss was being tolerated due to low cost of the manufacturing materials. This material loss was assessed at €58k p.a. However, the cost of handling the waste, the assigned high fixed costs for manufacturing the product, as well as the opportunity cost i.e. taking up valuable production line time, constraining use for other products sharing the line, was resulting in a total waste value to the company of >€1m.

Result

Process optimisation fixes were identified, implemented and the process revalidated. Operating margin for the product improved by ca. 25%, with annual manufacturing costs of the product reduced by €450k.

Capsule product at a CMO

Case Study 2

98.4%E2E yield, up from 95.5%
€1.45msaved annually by the Company
>€200ksaved annually by the CMO

Challenge

A capsule-format product was manufactured at a CMO using tolled API, supplied by the MAH company. Sales volumes of the product grew at ca. 10% p.a. averaged over the past 5 years. The MAH company finance and operations teams were satisfied with the stability of the Manufacturing Usage Variance (MUV) numbers year-over-year. As the API being used fell within the Top 5 most expensive materials being tolled to CMOs by the Company, a thorough review of the capsule manufacturing process was conducted in collaboration with the CMO. It was prior agreed that identified savings would be implemented to benefit both parties.

Approach

A process walkdown revealed multiple areas of improvement, including process scale-up to reduce changeover frequencies, analytical testing, QA touch-time etc. A process improvement roadmap was developed, showing the incremental activities required to move from an E2E Yield of 95.5%, to 96.8%, to 97.5%, to a final target of 98.4%. Costs, timelines and net value to the CMO and to the Company were separately developed.

Result

The Company saved €1.45m annually through yield increase from 95.5% to 98.4%, based entirely on reducing waste of the tolled API. The CMO saves >€200k annually due to a range of savings e.g. less time cleaning equipment, reduced QC analysis and samples management, less batch files vs product released, less waste associated with batch start-up and completion (materials in hoppers etc), more efficient use of raw materials etc.

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