A high-speed capsule filling line running in a pharmaceutical production facility

MANUFACTURING, SOURCING & BROKERAGE

The formula is the easy part.
Making it at scale is not.

The formula is the easy part.
Making it at scale is not.

A formula that works on the bench does not automatically work in a 500 kg blender, a capsule filler, or a stick pack line. Kompete selects the right manufacturing partner, translates your formula into documentation the factory can actually execute, and stays on the file through pilot, first production and packaging. You keep ownership of the formula and the relationship.

NO STAKE IN THE OUTCOME

We do not own the factory.

Most manufacturing advice comes from someone with capacity to fill. Kompete has none, which means the recommendation follows the dosage form, the volume, the certification requirements and the target landed cost rather than an internal utilization target. We qualify the site, negotiate the terms, and remain accountable for the technical package regardless of who runs the batch.

CONCEPT TO PALLET

Eight steps from approved formula to finished goods.

01

Manufacturability review

Assess whether the formula can be made at scale, flagging flow, compression, fill weight, solubility and stability risks before a partner is approached.

02

Partner selection

Shortlist qualified sites against dosage form, volume, certification, allergen control and geography, then run the RFQ.

03

Sourcing

Qualify raw material and packaging suppliers, review certificates of analysis, and secure branded ingredient licences where required.

04

Documentation

Build the master batch record, order of addition SOPs, in-process control points and finished product specification.

05

Pilot batch

Run a small scale trial to confirm blend uniformity, flow, fill accuracy and organoleptics before committing to full volume.

06

First production

Attend or oversee the first commercial run, resolve line issues in real time, and confirm in-process results against specification.

07

Release testing

Coordinate finished product testing, review the certificate of analysis and approve the batch for release.

08

Packaging and delivery

Manage primary and secondary packaging, coding, palletization and shipment to your warehouse or fulfilment partner.

Close-up of teal capsules being inserted into a filling plate

PILLAR 01

CMO and CDMO brokerage

Matching a product to a manufacturer is a technical decision before it is a commercial one. We know which sites run which dosage forms well.

Manufacturer matchmaking across capsules, tablets, powders, sticks, gummies, softgels, liquids and topicals

Site qualification covering certification status, allergen control, audit history and capacity

Request for quotation management and comparative cost analysis across bidders

Minimum order quantity negotiation and tiered pricing structures

Pre-validated private label options where speed to market outranks differentiation

Contract and supply agreement review from a technical standpoint

PILLAR 02

Raw material and packaging sourcing

Ingredient decisions made without regulatory input become reformulation costs later.

Raw material sourcing with supplier qualification and certificate of analysis review

Branded ingredient identification, licensing and claim rights confirmation

Clean label substitutions for flow agents, fillers and preservatives

Packaging and component brokerage including bottles, closures, films, sticks, sachets and cartons

Barrier and moisture protection selection matched to the stability profile

Cost engineering and landed cost modelling across sourcing scenarios

PILLAR 03

Technical transfer and batch documentation

The gap between a formula sheet and a factory-executable document is where most first runs go wrong.

Master batch records written to the receiving site’s format and systems

Order of addition blending SOPs with mixing times, speeds and equipment specified

In-process control points with defined acceptance criteria and sampling frequency

Scale-up calculations from bench to pilot to commercial batch size

Overage justification for actives with known process or shelf life losses

Equipment and process parameter recommendations by dosage form

PILLAR 04

Production oversight and quality release

Being in the room on the first run prevents the problems that show up in the third.

Pilot and line trial planning, attendance and troubleshooting

First production run oversight, on site or remote

Deviation and non-conformance investigation with root cause analysis

Certificate of analysis review and batch release recommendation

Retain sample and stability programme initiation at production scale

Post-launch process optimization and yield improvement

Capsule filling machine fading into darkness

THE TRANSFER PACKAGE

What we hand the factory.

A manufacturer cannot execute a spreadsheet of ingredients and percentages. The technical transfer package is the translation layer, and it is the single highest leverage document in the entire production process.

01

Master batch record

Batch size, full ingredient list with overages, weigh-up instructions, equipment, step by step process, yield reconciliation and sign-off points.

02

Order of addition

Sequenced blending instructions with mix times, speeds, screen sizes and hold points, written so a line operator can follow them without interpretation.

03

In-process controls

Defined checkpoints for blend uniformity, moisture, water activity, fill weight, capsule weight variation or tablet hardness, with acceptance criteria and action limits.

04

Finished product specification

Identity, potency, purity, physical and microbial limits with named test methods, forming the basis for batch release and regulatory submission.

PRACTICAL REFERENCE

Matching the format to the reality.

Every dosage form carries a different cost floor, lead time and technical risk. These are the ranges we work with when scoping a first production run.

DOSAGE FORM

TYPICAL FIRST-RUN MOQ

LEAD TIME

PRIMARY TECHNICAL RISK

Capsules

25,000 to 100,000 units

10 to 16 weeks

Powder flow and fill weight variation

Tablets

100,000 to 250,000 units

12 to 20 weeks

Compression, hardness and tooling cost

Powders and tubs

1,000 to 5,000 units

8 to 14 weeks

Blend uniformity and flavour system stability

Stick packs and sachets

25,000 to 100,000 sticks

10 to 16 weeks

Film selection, seal integrity and dosing accuracy

Gummies

50,000 to 150,000 units

14 to 22 weeks

Active stability in the cook, sticking and cold flow

Softgels

100,000 to 250,000 units

16 to 24 weeks

Shell compatibility and fill oxidation

Liquids and shots

5,000 to 20,000 units

10 to 18 weeks

Preservation, phase stability and container compatibility

Ranges are indicative. Actual minimums depend on the site, the ingredient set and the packaging format.

White bottles moving along a blue conveyor on a bottling line

Every format carries its own line speed, tooling and failure mode.

WHERE THE MONEY GOES

The quote is not the cost.

Kompete private label catalog and finished product packaging

A per-unit manufacturing quote typically accounts for a fraction of what a first production run actually costs. Tooling, artwork setup, film plates, minimum raw material buys, stability testing, certification fees, freight and the inventory sitting on a pallet all land after the quote is signed. Kompete builds the full landed cost model before you commit, identifies which line items are negotiable and which are fixed, and structures the first run so that a formula change after pilot does not write off the entire raw material purchase.

COST MODELLING

Full landed cost across manufacturing, raw materials, packaging, testing, certification and freight, modelled at multiple volume tiers.

RISK STAGING

Sequencing the commitment so pilot results inform the raw material purchase rather than following it.

SUPPLY CONTINUITY

Second source identification for critical ingredients and components before a shortage forces a reformulation.

ENGAGEMENT MODEL

Four steps from formula to first pallet.

01

Assess

We review the formula, target format, volume, markets and cost target, and tell you what is manufacturable as written and what needs to change.

02

Match

We shortlist and qualify sites, run the quoting process, and model the true landed cost of each option.

03

Transfer

We build the batch documentation, specifications and controls, and manage the pilot through to a validated first run.

04

Sustain

We stay on the file for release, deviations, second sourcing and the process improvements that follow the first few batches.

Know what it costs before you commit to the run.

Whether you are choosing a first manufacturer, moving a product between sites, or trying to understand why a batch failed, the starting point is a look at the formula and the numbers behind it.